header logo image


Page 9«..891011..2030..»

Archive for the ‘Genetic Engineering’ Category

The limits of synthetic biology through the origins of SARS-CoV-2 – Drug Target Review

Tuesday, September 15th, 2020

Conspiracy theories about COVID-19 have been spreading since the early days of the outbreak. But how do we know whether a biological entity is artificially made or has occurred naturally? Marc Baiget Francesch explores the capabilities of current scientific approaches in terms of virus engineering and how this applies to the present pandemic.

OVER THE LAST few months, numerous theories relating to the origin of the novel coronavirus SARS-CoV-2 have invaded the internet. Sometimes, these theories can give rise to more interesting discussions than what is originally intended by the authors. For example, the theory that the new coronavirus has been purposely made as a biological weapon would mean that SARS-CoV-2 is a synthetic organism, which simultaneously implies that scientists can create synthetic viruses. How much truth is there in that implication? How far can current technologies go in terms of artificial microorganisms design? To answer these questions, we first need to understand the current state of synthetic biology as a field and acknowledge its limitations.

While making a new virus from scratch is not technically impossible, it would require a level of knowledge that is implausible to imagine in any scientific institution at present

Synthetic biology greatly relies on predictive models and computer simulated structures. Computer programmes use the information collected by years of research in molecular biology, which is stored in huge libraries of microorganisms, molecules and domains, to explore their potential when modified or combined in silico that is, on a computer. The idea of these programmes is to form combinations that, presumably, do not exist in nature in order to analyse potential structures for multiple uses. However, despite in silico models providing valuable information and saving time and money on in vitro experimentation, they are far from perfect.

Professor JA Davies, from the University of Edinburgh, published a paper in the open access journal Life that analysed the current flaws of the engineering approach in synthetic biology. While he recognises that this approach, based on the design-build-test dogma, is interesting and that relying on standard pre-existing parts simplifies the overall design of synthetic structures, it lacks biological understanding.1

In biology, every component from a microorganism has a metabolic cost, ie, the more components you add to a cell, the less energy the cell can direct to each part. Therefore, the fewer parts used for a function, the better. In genetic engineering this is a crucial consideration, since adding new genes normally supposes that pre-existing genes are deleted in order for the organism to be viable. In addition, the interactions between two different pre-existing parts might affect its original function. Hence, as Professor Davies argues, using a novel part, designed for a specific function, might prove easier than trying to reproduce the same function with two pre-existing ones. Ultimately, evolution is based on constant changes of previous structures induced by a huge number of factors and not on the combination of unchanging structures. So, while synthetic biology can cover a lot of unexplored possibilities, it is still far from being an almighty tool or competing with natural evolution.

This brings us to the next question: how capable are current scientific approaches in terms of virus engineering? Researchers can recreate an existing virus from scratch, and this is what many research teams have been attempting since the coronavirus started to spread in order to understand the virus better.2 However, creating a new one is another story. It is possible to create new viruses from original ones; though, there are some restrictions. As aforementioned, synthetic biology relies on the use of pre-existing parts, which means we would need to use different parts of existing viruses and assemble them in order to produce a new virus. Dr Robert F Garry, a microbiologist specialising in virology, commented in Business Insider that there is no consensus on what exactly makes a virus pathogenic.3 Therefore, while making a new virus from scratch is not technically impossible, it would require a level of knowledge that is implausible to imagine in any scientific institution at present. Nevertheless, our current knowledge of molecular science allows us to identify potentially man-made structures or microorganisms.4 This is possible because they are based on pre-existent parts; an engineered virus would have identifiable segments of DNA that belong to other viruses whose sequences are stored in libraries. This means that we should be able to identify if a new virus was artificially designed or is a product of natural evolution.

To study the case of the novel coronavirus, we need to have access to its genetic sequence. This has been a major advancement in epidemiology, as for previous pandemics researchers had to wait from months to years in order to study the microorganism responsible for the outbreak, whereas the structure of SARS-CoV-2 was available within weeks. By analysing its genetic structure, scientists have realised that the backbone of the virus is, indeed, a new one.5 However, this does not mean that the virus was not artificially made; we just know that the backbone was not copied from another virus.

What about prompting an existent virus to mutate? It could be that biotechnologists induced mutations to a known virus in order to produce a novel one, like what we see in nature. However, when scientists evaluated the structure of SARS-CoV-2 and compared it to other viral structures, the closest relative they found was SARS-CoV RaTG13, which showed a 96 percent similarity to the novel coronavirus.6 Although 96 percent may seem a lot, considering the size of SARS-CoV-2, which is close to 30,000 nucleotides long, this four percent difference is quite significant around 1,200 nucleotides.7

Studying evolution and natural processes is key for synthetic biology to expand and become an even more powerful tool

Nevertheless, there may still be some resistance to debunking certain theories. One might argue that, while using known parts of similar viruses, targeted mutations could have been applied to give the virus the ability to attach to human cells which is essentially what makes this virus able to infect humans. One of the most curious facts about the coronavirus is that the receptor binding domain the part that makes SARS-CoV-2 able to attach to human cells was simulated in silico once the sequence of the virus was made available. This sequence showed poor efficiency on the simulations, meaning that nature has found a mechanism that we had not been able to predict.3 If we put together all the facts and reflect on the fact that 75 percent of the new emerging diseases are from zoonotic origin, it appears the theories around SARS-CoV-2 being a man-made virus are quite unrealistic, to say the least.8

Something I have found interesting since the search of the origin of the SARS-CoV-2 started, is that we have confirmed that synthetic biology still has a long way to go. We still need to understand a lot about nature to get a bigger picture of how things work and to grasp all the possibilities that molecular biology has to offer. Studying the evolution of viruses not only benefits the epidemiologists, but also the synthetic biologists, who gain insights into how molecular interactions work. This newfound knowledge can be used to improve current models and propose frameworks for the creation of new molecules. Therefore, one can conclude that studying evolution and natural processes is key for synthetic biology to expand and become an even more powerful tool.

Marc Baiget Francesch is an MSc in Pharmaceutical Engineering and currently works as an Assistant Editor for the International Journal of Molecular Sciences. He also writes articles and innovation grants as a freelancer.

Excerpt from:
The limits of synthetic biology through the origins of SARS-CoV-2 - Drug Target Review

Read More...

Bio-weapon warning: Next pandemic could be genetically engineered, experts warn – Daily Express

Tuesday, September 15th, 2020

Terrorists could genetically modify diseases to attack their enemies, and the consequences would be far more devastating than an outbreak of natural origin, scientists believe. If terrorists were able to obtain the biotechnology which allowed them to genetically modify a pathogen or virus, the consequences could be deadly for humanity and it could be the root of the next major pandemic.

The world has struggled to cope with a virus outbreak of natural origins in the coronavirus pandemic, with almost one million dead.

However, if a new virus were to be engineered, it would be completely foreign to scientists who would ultimately struggle to be able to contain and find a cure.

Vivek Wadhwa from Harvard Law Schoool, said advancements in gene-editing technology such as CRISPR are making it easier to create bioweapons.

Much in the same way as vaccines are created by identifying the antigen which triggers the immune response which are then isolated and then injected it into humans a similar process could happen by identifying the lethal traits in viruses to make them even more harmful.

Mr Wadwha wrote in an essay for Foreign Policy: "With COVID-19 bringing Western economies to their knees, all the worlds dictators now know that pathogens can be as destructive as nuclear missiles.

"Whats even more worrying is that it no longer takes a sprawling government lab to engineer a virus.

"Thanks to a technological revolution in genetic engineering, all the tools needed to create a virus have become so cheap, simple, and readily available that any rogue scientist or college-age biohacker can use them, creating an even greater threat.

It is now too late to stop the global spread of these technologies the genie is out of the bottle.

READ MORE:Coronavirus conspiracy theory: Claims of bioweapons and the apocalypse

"We must treat the coronavirus pandemic as a full dress rehearsal of what is to come unfortunately, that includes not only viruses that erupt from nature, but also those that will be deliberately engineered by humans.

Mr Wadhwa is not the only expert concerned about the potential rise of bioterrorism.

Bryan Walsh, author of the book End Times which details the existential threats humanity faces, told Express.co.uk: When I look into the near future, the thing that worries me the most is the threat of a bioengineered pandemic created out the lab using some of these new tools for genetic editing.

"That is particularly dangerous because diseases and pandemics are a threat already but what could be created in a lab on purpose say by terrorists would be much worse than anything created by nature."

DON'T MISSBill Gates: Terrorists could kill TENS OF MILLIONS with BIOWEAPONSNext biological weapon FOUND? Insect ARMY being harnessed in the USWas this coronavirus PATIENT ZERO? Vicious bat attack at Chinese lab

Other scientists, however, are more optimistic about the benefits of CRISPR and other gene-editing tools.

Helen ONeill, a molecular geneticist at University College London, believes disease could one day be irradiated through genetic modification.

She said: There are endless capacities when it comes to gene editing.

We can take your blood cells, we fix them and reinsert them back in to you.

"Soon every baby will have every letter of its genome read on the day it is born so we can tailor medication for them.

View original post here:
Bio-weapon warning: Next pandemic could be genetically engineered, experts warn - Daily Express

Read More...

Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Production Capacity to Over 2…

Tuesday, September 15th, 2020

GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVXCoV2373, Novavax COVID19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVXCoV2373 is a stable, prefusion protein made using Novavax recombinant protein nanoparticle technology and includes Novavax proprietary MatrixM adjuvant.

Todays agreement with Serum Institute enhances Novavax commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents, said Stanley C. Erck, President and Chief Executive Officer of Novavax. We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks.

The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021.

The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:

Novavax Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:

Signing of the manufacturing agreement with Novavax for NVX-CoV2373 is another great milestone for both companies, which will further strengthen our existing relationship. SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help ensure the supply of this most-needed vaccine, said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.

About NVX-CoV2373

NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

About Matrix-M

Novavax patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

About Serum Institute of India

Serum Institute of India Pvt. Ltd. was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics. Serum is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

Serum is ranked as India's No. 1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.

The philanthropic philosophy of Serum continues with its work on newer vaccines and biologicals.

Learn more about Serum Institute of India at https://www.seruminstitute.com/.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

Novavax Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading Risk Factors in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Novavax

InvestorsSilvia Taylor and Erika Trahanir@novavax.com240-268-2022

MediaBrandzone/KOGS CommunicationEdna Kaplankaplan@kogspr.com617-974-8659

More:
Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax' Global Production Capacity to Over 2...

Read More...

Death by COVID: 5 immune response markers that predict whether an infected person is likely to survive – Genetic Literacy Project

Tuesday, September 15th, 2020

[Researchers] have identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, and those who didnt survive the disease. The researchers used a systems serology technique to generate a detailed profile of SARS-Co-2-specific humoralantibody generatingresponses in hospitalized patients, which they validated in a second patient cohort. The findings indicated that individuals who survived COVID-19 infection and those who died exhibited antibody responses that were primarily directed against different SARS-CoV-2 proteins.

By looking at the overall profile of the immune response, we can begin to truly understand how the immune system responds to COVID-19 and then use that knowledge to prevent the worst outcomes of this disease, [said researcher Galit Alter.]

Its still not clear why some individuals infected with SARS-CoV-2 recover from infection and others die, the authors noted. While the rapid spread of SARS-CoV-2, even during the asymptomatic phase of this infection, is alarming, more harrowing is our inability to predict disease trajectories among symptomatic individuals. And without any therapeutics or vaccines as countermeasures, there is an urgent need to start mapping how immunity to the virus starts to develop. This knowledge will not only help to guide patient care, but could help to direct the development of future immune-based strategies against the disorder.

Read the original post

Read more:
Death by COVID: 5 immune response markers that predict whether an infected person is likely to survive - Genetic Literacy Project

Read More...

Was COVID-19 Manmade? Meet the Scientist Behind the Theory – Boston magazine

Tuesday, September 15th, 2020

Research

The worlds preeminent scientists say a theory from the Broad Institutes Alina Chan is too wild to be believed. But when the theory is about the possibility of COVID being man-made, is this science or censorship?

Illustration by Benjamen Purvis

In January, as she watched the news about a novel virus spreading out of control in China, Alina Chan braced for a shutdown. The molecular biologist at the Broad Institute of Harvard and MIT started stockpiling medicine and supplies. By the time March rolled around and a quarantine seemed imminent, shed bought hundreds of dollars worth of fillets from her favorite fishmonger in Cambridge and packed them into her freezer. Then she began to ramp down her projects in the lab, isolating her experimental cells from their cultures and freezing them in small tubes.

As prepared as she was for the shutdown, though, she found herself unprepared for the frustration of being frozen out of work. She paced the walls of her tiny apartment feeling bored and useless. Chan has been a puzzle demon since childhood, which was precisely what she loved about her workthe chance to solve fiendishly difficult problems about how viruses operate and how, through gene therapy, they could be repurposed to help cure devastating genetic diseases. Staring out her window at the eerily quiet streets of her Inman Square neighborhood, she groaned at the thought that it could be months before she was at it again. Her mind wandered back to 2003, when she was a teenager growing up in Singapore and the first SARS virus, a close relative of this coronavirus, appeared in Asia. It hadnt been anything like this. That one had been relatively easy to corral. How had this virus come out of nowhere and shut down the planet? Why was it so different? she asked herself.

Then it hit her: The worlds greatest puzzle was staring her in the face. Stuck at home, all she had to work with was her brain and her laptop. Maybe they were enough. Chan fired up the kettle for the first of what would become hundreds of cups of tea, stacked four boxes on her kitchen counter to raise her laptop to the proper height, pulled back her long dark hair, and began reading all of the scientific literature she could find on the coronavirus.

It wasnt long before she came across an article about the remarkable stability of the virus, whose genome had barely changed from the earliest human cases, despite trillions of replications. This perplexed Chan. Like many emerging infectious diseases, COVID-19 was thought to be zoonoticit originated in animals, then somehow found its way into people. At the time, the Chinese government and most scientists insisted the jump had happened at Wuhans seafood market, but that didnt make sense to Chan. If the virus had leapt from animals to humans in the market, it should have immediately started evolving to life inside its new human hosts. But it hadnt.

On a hunch, she decided to look at the literature on the 2003 SARS virus, which had jumped from civets to people. Bingo. A few papers mentioned its rapid evolution in its first months of existence. Chan felt the familiar surge of puzzle endorphins. The new virus really wasnt behaving like it should. Chan knew that delving further into this puzzle would require some deep genetic analysis, and she knew just the person for the task. She opened Google Chat and fired off a message to Shing Hei Zhan. He was an old friend from her days at the University of British Columbia and, more important, he was a computational god.

Do you want to partner on a very unusual paper? she wrote.

Sure, he replied.

One thing Chan noticed about the original SARS was that the virus in the first human cases was subtly differenta few dozen letters of genetic codefrom the one in the civets. That meant it had immediately morphed. She asked Zhan to pull up the genomes for the coronaviruses that had been found on surfaces in the Wuhan seafood market. Were they at all different from the earliest documented cases in humans?

Zhan ran the analysis. Nope, they were 100 percent the same. Definitely from humans, not animals. The seafood-market theory, which Chinese health officials and the World Health Organization espoused in the early days of the pandemic, was wrong. Chans puzzle detectors pulsed again. Shing, she messaged Zhan, this paper is going to be insane.

In the coming weeks, as the spring sun chased shadows across her kitchen floor, Chan stood at her counter and pounded out her paper, barely pausing to eat or sleep. It was clear that the first SARS evolved rapidly during its first three months of existence, constantly fine-tuning its ability to infect humans, and settling down only during the later stages of the epidemic. In contrast, the new virus looked a lot more like late-stage SARS. Its almost as if were missing the early phase, Chan marveled to Zhan. Or, as she put it in their paper, as if it was already well adapted for human transmission.

That was a profoundly provocative line. Chan was implying that the virus was already familiar with human physiology when it had its coming-out party in Wuhan in late 2019. If so, there were three possible explanations.

Perhaps it was just staggeringly bad luck: The mutations had all occurred in an earlier host species, and just happened to be the perfect genetic arrangement for an invasion of humanity. But that made no sense. Those mutations would have been disadvantageous in the old host.

Maybe the virus had been circulating undetected in humans for months, working out the kinks, and nobody had noticed. Also unlikely. Chinas health officials would not have missed it, and even if they had, theyd be able to go back now through stored samples to find the trail of earlier versions. And they werent coming up with anything.

That left a third possibility: The missing phase had happened in a lab, where the virus had been trained on human cells. Chan knew this was the third rail of potential explanations. At the time, conspiracy theorists were spinning bioweapon fantasies, and Chan was loath to give them any ammunition. But she also didnt want to play politics by withholding her findings. Chan is in her early thirties, still at the start of her career, and an absolute idealist about the purity of the scientific process. Facts were facts.

Or at least they used to be. Since the start of the pandemic, the Trump administration has been criticized for playing fast and loose with factsdenying, exaggerating, or spinning them to suit the presidents political needs. As a result, many scientists have learned to censor themselves for fear that their words will be misrepresented. Still, Chan thought, if she were to sit on scientific research just to avoid providing ammunition to conspiracy theorists or Trump, would she be any better than them?

Chan knew she had to move forward and make her findings public. In the final draft of her paper, she torpedoed the seafood-market theory, then laid out a case that the virus seemed curiously well adapted to humans. She mentioned all three possible explanations, carefully wording the third to emphasize that if the novel coronavirus did come from a lab, it would have been the result of an accident in the course of legitimate research.

On May 2, Chan uploaded the paper to a site where as-yet-unpublished biology papers known as preprints are shared for open peer review. She tweeted out the news and waited. On May 16, the Daily Mail, a British tabloid, picked up her research. The very next day, Newsweek ran a story with the headline Scientists Shouldnt Rule Out Lab as Source of Coronavirus, New Study Says.

And that, Chan says, is when shit exploded everywhere.

Alina Chan, a molecular biologist at the Broad Institute, says we cant rule out the possibility that the novel coronavirus originated in a labeven though she knows its a politically radioactive thing to say. / Photo by Mona Miri

Chan had come to my attention a week before the Newsweek story was published through her smart and straightforward tweets, which I found refreshing at a time when most scientists were avoiding any serious discussion about the possibility that COVID-19 had escaped from a biolab. Id written a lot about genetic engineering and so-called gain-of-function researchthe fascinating, if scary, line of science in which scientists alter viruses to make them more transmissible or lethal as a way of assessing how close those viruses are to causing pandemics. I also knew that deadly pathogens escape from biolabs with surprising frequency. Most of these accidents end up being harmless, but many researchers have been infected, and people have died as a result.

For years, concerned scientists have warned that this type of pathogen research was going to trigger a pandemic. Foremost among them was Harvard epidemiologist Marc Lipsitch, who founded the Cambridge Working Group in 2014 to lobby against these experiments. In a series of policy papers, op-eds, and scientific forums, he pointed out that accidents involving deadly pathogens occurred more than twice a week in U.S. labs, and estimated that just 10 labs performing gain-of-function research over a 10-year period would run a nearly 20 percent risk of an accidental release. In 2018, he argued that such a release could lead to global spread of a virulent virus, a biosafety incident on a scale never before seen.

Thanks in part to the Cambridge Working Group, the federal government briefly instituted a moratorium on such research. By 2017, however, the ban was lifted and U.S. labs were at it again. Today, in the United States and across the globe, there are dozens of labs conducting experiments on a daily basis with the deadliest known pathogens. One of them is the Wuhan Institute of Virology. For more than a decade, its scientists have been discovering coronaviruses in bats in southern China and bringing them back to their lab in Wuhan. There, they mix genes from different strains of these novel viruses to test their infectivity in human cells and lab animals.

When word spread in January that a novel coronavirus had caused an outbreak in Wuhanwhich is a thousand miles from where the bats that carry this lineage of viruses are naturally foundmany experts were quietly alarmed. There was no proof that the lab was the source of the virus, but the pieces fit.

Despite the evidence, the scientific community quickly dismissed the idea. Peter Daszak, president of EcoHealth Alliance, which has funded the work of the Wuhan Institute of Virology and other labs searching for new viruses, called the notion preposterous, and many other experts echoed that sentiment.

That wasnt necessarily what every scientist thought in private, though. They cant speak directly, one scientist told me confidentially, referring to the virology communitys fear of having their comments sensationalized in todays politically charged environment. Many virologists dont want to be hated by everyone in the field.

There are other potential reasons for the pushback. Theres long been a sense that if the public and politicians really knew about the dangerous pathogen research being conducted in many laboratories, theyd be outraged. Denying the possibility of a catastrophic incident like this, then, could be seen as a form of career preservation. For the substantial subset of virologists who perform gain-of-function research, Richard Ebright, a Rutgers microbiologist and another founding member of the Cambridge Working Group, told me, avoiding restrictions on research funding, avoiding implementation of appropriate biosafety standards, and avoiding implementation of appropriate research oversight are powerful motivators. Antonio Regalado, biomedicine editor of MIT Technology Review, put it more bluntly. If it turned out COVID-19 came from a lab, he tweeted, it would shatter the scientific edifice top to bottom.

Thats a pretty good incentive to simply dismiss the whole hypothesis, but it quickly amounted to a global gaslighting of the mediaand, by proxy, the public. An unhealthy absolutism set in: Either you insisted that any questions about lab involvement were absurd, or you were a tool of the Trump administration and its desperation to blame China for the virus. I was used to social media pundits ignoring inconvenient or politically toxic facts, but Id never expected to see that from some of our best scientists.

Which is why Chan stood out on Twitter, daring to speak truth to power. It is very difficult to do research when one hypothesis has been negatively cast as a conspiracy theory, she wrote. Then she offered some earnest advice to researchers, suggesting that most viral research should be done with neutered viruses that have had their replicating machinery removed in advance, so that even if they escaped confinement, they would be incapable of making copies of themselves. When these precautions are not followed, risk of lab escape is exponentially higher, she explained, adding, I hope the pandemic motivates local ethics and biosafety committees to think carefully about how they can reduce risk. She elaborated on this in another tweet several days later: Id alsopersonallyprefer if high biosafety level labs were not located in the most populous cities on earth.

How Safe Are Bostons Biolabs?

As one of the world centers of biotech, the Hub is peppered with academic and corporate labs doing research on pathogens. Foremost among them is Boston Universitys National Emerging Infectious Diseases Laboratories (NEIDL), the only lab in the city designated as BSL-4 (the highest level of biosafety and the same level as the Wuhan Institute of Virology). It is one of just a dozen or so in the United States equipped to work with live versions of the worlds most dangerous viruses, including Ebola and Marburg. Researchers there began doing so in 2018 after a decade of controversy: Many locals objected to the risks of siting such a facility in the center of a major metropolitan area.

The good news? Before opening, NEIDL undertook one of the most thorough risk assessments in history, learning from the mistakes of other facilities. Even Lynn Klotz, a senior science fellow at the Washington, DCbased Center for Arms Control and Non-Proliferation, who advised local groups that opposed NEIDL, told the medical website Contagion that the lab likely has the best possible security protocols and measures in place.

But the reality, Klotz added, is that most lab accidents are caused by human error, and there is only so much that can be done through good design and protocols to proactively prevent such mistakes. (Or to guard against an intentional release by a disgruntled researcher, as allegedly happened in the anthrax attacks of 2001.) Rutgers molecular biologist Richard Ebright, a longtime critic of potentially dangerous pathogen research, says the risks introduced by NEIDL are not low enough and definitely not worth the negligible benefits.

Still, risk is relative. Klotz has estimated the chance of a pathogen escape from a BSL-4 lab at 0.3 percent per year, and NEIDL is probably significantly safer than the typical BSL-4 lab. And if catching a deadly pathogen is your fear, well, currently you run a good risk of finding one in your own neighborhood. Until that gets cleared up, the citys biolabs are probably among the safer spaces in town.

Chan had started using her Twitter account this intensely only a few days earlier, as a form of outreach for her paper. The social platform has become the way many scientists find out about one anothers work, and studies have shown that attention on Twitter translates to increased citations for a paper in scientific literature. But its a famously raw forum. Many scientists are not prepared for the digital storms that roil the Twitterverse, and they dont handle it well. Chan dreaded it at first, but quickly took to Twitter like a digital native. Having Twitter elevates your work, she says. And I think its really fun to talk to nonscientists about that work.

After reading her tweets, I reviewed her preprint, which I found mind-blowing, and wrote her to say so. She thanked me and joked that she worried it might be career suicide.

It wasnt long before it began to look like she might be right.

Speaking her mind, it turns outeven in the face of censurewas nothing new for Chan, who is Canadian but was raised in Singapore, one of the more repressive regimes on earth. Her parents, both computer science professionals, encouraged free thinking and earnest inquiry in their daughter, but the local school system did not. Instead, it was a pressure-cooker of a system that rewarded students for falling in line, and moved quickly to silence rebels.

That was a bad fit for Chan. You have to bow to teachers, she says. Sometimes teachers from other classes would show up and ask me to bow to them. And I would say, No, youre not my teacher. Back then they believed in corporal punishment. A teacher could just take a big stick and beat you in front of the class. I got whacked so many times.

Still, Chan rebelled in small ways, skipping school and hanging out at the arcade. She also lost interest in her studies. I just really didnt like school. And I didnt like all the extracurriculars they pack you with in Singapore, she says. That changed when a teacher recruited her for math Olympiads, in which teams of students compete to solve devilishly hard arithmetic puzzles. I really loved it, she says. You just sit in a room and think about problems.

Chan might well have pursued a career in math, but then she came up against teams from China in Olympiad competitions. They would just wipe everyone else off the board, she says. They were machines. Theyd been trained in math since they could walk. Theyd hit the buzzer before you could even comprehend the question. I thought, Im not going to survive in this field.

Chan decided to pursue biology instead, studying at the University of British Columbia. I liked viruses from the time I was a teen, she says. I remember the first time I learned about HIV. I thought it was a puzzle and a challenge. That instinct took her to Harvard Medical School as a postdoc, where the puzzle became how to build virus-like biomolecules to accomplish tasks inside cells, and then to Ben Devermans lab at the Broad Institute. When I see an interesting question, I want to spend 100 percent of my time working on it, she says. I get really fixated on answering scientific questions.

Deverman, for his part, says he wasnt actively looking to expand his team when Chan came along, but when opportunities to hire extraordinary people fall in my lap, he takes them. Alina brings a ton of value to the lab, he explains, adding that she has an ability to pivot between different topics and cut to the chase. Nowhere was that more on display than with her coronavirus work, which Deverman was able to closely observe. In fact, Chan ran so many ideas past him that he eventually became a coauthor. She is insightful, determined, and has the rare ability to explain complex scientific findings to other scientists and to the public, he says.

Those skills would prove highly useful when word got out about her coronavirus paper.

If Chan had spent a lifetime learning how to pursue scientific questions, she spent most of the shutdown learning what happens when the answers you come up with are politically radioactive. After the Newsweek story ran, conservative-leaning publications seized on her paper as conclusive evidence that the virus had come from a lab. Everyone focused on the one line, Chan laments. The tabloids just zoomed in on it. Meanwhile, conspiracists took it as hard evidence of their wild theories that there had been an intentional leak.

Chan spent several exhausting days putting out online fires with the many people who had misconstrued her findings. I was so naive, she tells me with a quick, self-deprecating laugh. I just thought, Shouldnt the world be thinking about this fairly? I really have to kick myself now.

Even more troubling, though, were the reactions from other scientists. As soon as her paper got picked up by the media, luminaries in the field sought to censure her. Jonathan Eisen, a well-known professor at UC Davis, criticized the study in Newsweek and on his influential Twitter account, writing, Personally, I do not find the analysis in this new paper remotely convincing. In a long thread, he argued that comparing the new virus to SARS was not enough to show that it was preadapted to humans. He wanted to see comparisons to the initial leap of other viruses from animals to humans.

Moments later, Daszak piled on. The NIH had recently cut its grant to his organization, EcoHealth Alliance, after the Trump administration learned that some of it had gone to fund the Wuhan Institute of Virologys work. Daszak was working hard to get it restored and trying to stamp out any suggestion of a lab connection. He didnt hold back on Chan. This is sloppy research, he tweeted, calling it a poorly designed phylogenetic study with too many inferences and not enough data, riding on a wave of conspiracy to drive a higher impact. Peppering his tweets with exclamation points, he attacked the wording of the paper, arguing that one experiment it cited was impossible, and told Chan she didnt understand her own data. Afterward, a Daszak supporter followed up his thread with a GIF of a mike drop.

It was an old and familiar dynamic: threatened silverback male attempts to bully a junior female member of the tribe. As a postdoc, Chan was in a vulnerable position. The world of science is still a bit medieval in its power structure, with a handful of institutions and individuals deciding who gets published, who gets positions, who gets grants. Theres little room for rebels.

What happened next was neither old nor familiar: Chan didnt back down. Sorry to disrupt mike drop, she tweeted, providing a link to a paper in the prestigious journal Nature that does that exact experiment you thought was impossible. Politely but firmly, she justified each point Daszak had attacked, showing him his mistakes. In the end, Daszak was reduced to arguing that she had used the word isolate incorrectly. In a coup de grce, Chan pointed out that actually the word had come from online data provided by GenBank, the NIHs genetic sequence database. She offered to change it to whatever made sense. At that point, Daszak stopped replying. He insists, however, that Chan is overinterpreting her findings.

With Eisen, Chan readily agreed to test her hypothesis by finding other examples of viruses infecting new hosts. Within days, a perfect opportunity came along when news broke that the coronavirus had jumped from humans to minks at European fur farms. Sure enough, the mink version began to rapidly mutate. You actually see the rapid evolution happening, Chan said. Just in the first few weeks, the changes are quite drastic.

Chan also pointed out to Eisen that the whole goal of a website such as bioRxiv (pronounced bioarchive)where she posted the paperis to elicit feedback that will make papers better before publication. Good point, he replied. Eventually he conceded that there was a lot of interesting analysis in the paper and agreed to work with Chan on the next draft.

The Twitter duels with her powerful colleagues didnt rattle Chan. I thought Jonathan was very reasonable, she says. I really appreciated his expertise, even if he disagreed with me. I like that kind of feedback. It helped to make our paper better.

With Daszak, Chan is more circumspect. Some people have trouble keeping their emotions in check, she says. Whenever I saw his comments, Id just think, Is there something I can learn here? Is there something hes right about that I should be fixing? Ultimately, she decided, there was not.

By late May, both journalists and armchair detectives interested in the mystery of the coronavirus were discovering Chan as a kind of Holmes to our Watson. She crunched information at twice our speed, zeroing in on small details wed overlooked, and became a go-to for anyone looking for spin-free explications of the latest science on COVID-19. It was thrilling to see her reasoning in real time, a reminder of why Ive always loved science, with its pursuit of patterns that sometimes leads to exciting revelations. The website CNET featured her in a story about a league of scientists-turned-detectives who were using genetic sequencing technologies to uncover COVID-19s origins. After it came out, Chan added scientist-turned-detective to her Twitter bio.

Shes lived up to her new nom de tweet. As the search for the source of the virus continued, several scientific teams published papers identifying a closely related coronavirus in pangolinsanteater-like animals that are heavily trafficked in Asia for their meat and scales. The number of different studies made it seem as though this virus was ubiquitous in pangolins. Many scientists eagerly embraced the notion that the animals might have been the intermediate hosts that had passed the novel coronavirus to humans. It fit their preexisting theories about wet markets, and it would have meant no lab had been involved.

As Chan read the pangolin papers, she grew suspicious. The first one was by a team that had analyzed a group of the animals intercepted by anti-smuggling authorities in southern China. They found the closely related virus in a few of them, and published the genomes for that virus. Some of the other papers, though, were strangely ambiguous about where their data was coming from, or how their genomes had been constructed. Had they really taken samples from actual pangolins?

Once again, Chan messaged Shing Hei Zhan. Shing, somethings weird here, she wrote. Zhan pulled up the raw data from the papers and compared the genomes they had published. Individual copies of a virus coming from different animals should have small differences, just as individuals of a species have genetic differences. Yet the genomes in all of the pangolin papers were perfect matchesthe authors were all simply using the first groups data set. Far from being ubiquitous, the virus had been found only in a few pangolins who were held together, and it was unclear where they had caught it. The animals might have even caught it from their own smuggler.

Remarkably, one group of authors in Nature even appeared to use the same genetic sequences from the other paper as if it were confirmation of their own discovery. These sequences appear to be from the same virus (Pangolin-CoV) that we identified in the present study.

Chan called them out on Twitter: Of course its the same Pangolin-CoV, you used the same dataset! For context, she later added, Imagine if clinical trials were playing fast and loose with their patient data; renaming patients, throwing them into different datasets without clarification, possibly even describing the same patient multiple times across different studies unintentionally.

She and Zhan posted a new preprint on bioRxiv dismantling the pangolin papers. Confirmation came in June when the results of a study of hundreds of pangolins in the wildlife trade were announced: Not a single pangolin had any sign of a coronavirus. Chan took a victory lap on Twitter: Supports our hypothesis all this time. The pangolin theory collapsed.

Chan then turned her Holmesian powers on bigger game: Daszak and the Wuhan Institute of Virology. Daszak had been pleading his case everywhere from 60 Minutes to the New York Times and has been successful in rallying sympathy to his cause, even getting 77 Nobel laureates to sign a letter calling for the NIH to restore EcoHealth Alliances funding.

In several long and detailed tweetorials, Chan began to cast a cloud of suspicion on the WIVs work. She pointed out that scientists there had discovered a virus that is more than 96 percent identical to the COVID-19 coronavirus in 2013 in a mineshaft soon after three miners working there had died from a COVID-like illness. The WIV didnt share these findings until 2020, even though the goal of such work, Chan pointed out, was supposedly to identify viruses with the potential to cause human illnesses and warn the world about them.

Even though that virus had killed three miners, Daszak said it wasnt considered a priority to study at the time. We were looking for SARS-related virus, and this one was 20 percent different. We thought it was interesting, but not high risk. So we didnt do anything about it and put it in the freezer, he told a reporter from Wired. It was only in 2020, he maintained, that they started looking into it once they realized its similarity to COVID-19. But Chan pointed to an online database showing that the WIV had been genetically sequencing the mine virus in 2017 and 2018, analyzing it in a way they had done in the past with other viruses in preparation for running experiments with them. Diplomatic yet deadpan, she wrote, I think Daszak was misinformed.

For good measure, almost in passing, Chan pointed out a detail no one else had noticed: COVID-19 contains an uncommon genetic sequence that has been used by genetic engineers in the past to insert genes into coronaviruses without leaving a trace, and it falls at the exact point that would allow experimenters to swap out different genetic parts to change the infectivity. That same sequence can occur naturally in a coronavirus, so this was not irrefutable proof of an unnatural origin, Chan explained, only an observation. Still, it was enough for one Twitter user to muse, If capital punishment were as painful as what Alina Chan is doing to Daszak/WIV regarding their story, it would be illegal.

Daszak says that indeed he had been misinformed and was unaware that that virus found in the mine shaft had been sequenced before 2020. He also says that a great lab, with great scientists, is now being picked apart to search for suspicious behavior to support a preconceived theory. If you believe, deep down, something fishy went on, then what you do is you go through all the evidence and you try to look for things that support that belief, he says, adding, That is not how you find the truth.

Many of the points in Chans tweetorials had also been made by others, but she was the first reputable scientist to put it all together. That same week, Londons Sunday Times and the BBC ran stories following the same trail of breadcrumbs that Chan had laid out to suggest that there had been a coverup at the WIV. The story soon circulated around the world. In the meantime, the WIV has steadfastly denied any viral leak. Lab director Yanyi Wang went on Chinese television and described such charges as pure fabrication, and went on to explain that the bat coronavirus from 2013 was so different than COVID that it could not have evolved into it this quickly and that the lab only sequenced it and didnt obtain a live virus from it.

To this day, there is no definitive evidence as to whether the virus occurred naturally or had its origins in a lab, but the hypothesis that the Wuhan facility was the source is increasingly mainstream and the science behind it can no longer be ignored. And Chan is largely to thank for that.

In late spring, Chan walked through the tall glass doors of the Broad Institute for the first time in months. As she made her way across the gleaming marble foyer, her sneaker squeaks echoed in the silence. It was like the zombie apocalypse version of the Broad; all the bright lights but none of the people. It felt all the weirder that she was wearing her gym clothes to work.

A few days earlier, the Broad had begun letting researchers back into their labs to restart their projects. All computer work still needed to be done remotely, but bench scientists such as Chan could pop in just long enough to move along their cell cultures, provided they got tested for the virus every four days.

In her lab, Chan donned her white lab coat and took inventory, throwing out months of expired reagents and ordering new materials. Then she rescued a few samples from the freezer, took her seat at one of the tissue-culture hoodsstainless steel, air-controlled cabinets in which cell engineers do their workand began reviving some of her old experiments.

She had mixed emotions about being back. It felt good to free her gene-therapy projects from their stasis, and she was even more excited about the new project she and Deverman were working on: an online tool that allows vaccine developers to track changes in the viruss genome by time, location, and other characteristics. It came out of my personal frustration at not being able to get answers fast, she says.

On the other hand, she missed being all-consumed by her detective work. I wanted to stop after the pangolin preprint, she says, but this mystery keeps drawing me back in. So while she waits for her cell cultures to grow, shes been sleuthing on the sideonly this time she has more company: Increasingly, scientists have been quietly contacting her to share their own theories and papers about COVID-19s origins, forming something of a growing underground resistance. Theres a lot of curiosity, she says. People are starting to think more deeply about it. And they have to, she says, if we are going to prevent future outbreaks: Its really important to find out where this came from so it doesnt happen again.

That is what keeps Chan up at nightthe possibility of new outbreaks in humans from the same source. If the virus emerged naturally from a bat cave, there could well be other strains in existence ready to spill over. If they are closely related, whatever vaccines we develop might work on them, too. But that might not be the case with manipulated viruses from a laboratory. Someone could have been sampling viruses from different caves for a decade and just playing mix-and-match in the lab, and those viruses could be so different from one another that none of our vaccines will work on them, she says. Either way, We need to find where this came from, and close it down.

Whatever important information she finds, we can be sure Chan will share it with the world. Far from being shaken by the controversy her paper stirred, she is more committed than ever to holding a line that could all too easily be overrun. Scientists shouldnt be censoring themselves, she says. Were obliged to put all the data out there. We shouldnt be deciding that its better if the public doesnt know about this or that. If we start doing that, we lose credibility, and eventually we lose the publics trust. And thats not good for science. In fact, it would cause an epidemic of doubt, and that wouldnt be good for any of us.

Read the original post:
Was COVID-19 Manmade? Meet the Scientist Behind the Theory - Boston magazine

Read More...

New study by ICGEB-Emory Vaccine Center offers hope to improve Indias plasma therapy regimen – Express Healthcare

Tuesday, September 15th, 2020

Study highlights role of IgG antibodies that bind to the receptor binding domain (RBD) of the SARS-CoV-2, and not the IgG antibodies that bind to the whole viral protein mix, as an excellent surrogate measurement to estimate neutralising antibodies

While intensive efforts continue to focus on development of an effective vaccine, anti-viral or other therapeutic entity, plasma therapy is currently being widely explored as an interim strategy to treat COVID-19.

A recent study by ICMR while raising the lack of benefits from plasma therapy, has highlighted the urgent need for prior measurement of neutralising antibody titres in donors and participants, which may better aid in delineating the role of plasma therapy in management of COVID-19.

Neutralising antibodies, typically of IgG subclass that can potentially block viral infection, are key components for the success of plasma therapy and titers of >320 are generally considered most suitable for successful plasma therapy. Currently, however, mere presence of IgG antibody, regardless of its neutralising ability, is used as a selection criterion for donor convalescent plasma because assessment of neutralising antibodies in routine clinical samples remains a challenge.

Thus, it is important to note that we have insufficient knowledge to understand whether all donors had sufficient titers of neutralising antibodies to donate plasma, and whether these titers reflected in all recipients that received the transfusion.

In this direction, a new ICMR funded study led by Drs Anmol Chandele and Kaja Murali Krishna of ICGEB-Emory Vaccine Center at the International Centre for Genetic Engineering and Biotechnology, in collaboration with ICMR-National Institute of Malaria Research, Department of Biotechnology and the Emory Vaccine Center, Atlanta gives new hope to improve plasma therapy regimen in India1.

This study finds that nearly half of the COVID-19 recovered individuals examined did not have appreciable levels of neutralising antibodies despite having SARS-CoV-2 specific IgG. More importantly, this study finds that it was IgG antibodies that bind to the receptor binding domain (RBD) of the SARS-CoV-2, and not the IgG antibodies that bind to the whole viral protein mix, served as an excellent surrogate measurement to estimate neutralising antibodies. They report that RBD binding IgG titers of more than 1:3000 indicate neutralising antibody levels of more 1:320, a titer which is likely to increase chances of success with plasma therapy.

It is important to note that many Indian government agencies and institutions are already making efforts to bring these RBD-based IgG assays more widely available, and thus this study is very relevant and timely to scientifically validate these efforts. It is notable that the Translational Health Sciences and Technology Institute (THSTI), which is another institute within the Delhi NCR biocluster, has made available an in-house RBD IgG ELISA assay that was recently used for a sero-survey in Pune and very recently RBD IgG assay facility is has been inaugurated in Nagpur.

These basic research efforts currently pursued at the ICGEB-Emory Vaccine Center to understand human immunology of COVID-19 infections in India, gives renewed hope to tailor and improve plasma therapy in India.

References:

Read the original:
New study by ICGEB-Emory Vaccine Center offers hope to improve Indias plasma therapy regimen - Express Healthcare

Read More...

Promoting CRISPR crops at the expense of GMOs is short-sighted when we need both – Genetic Literacy Project

Tuesday, September 15th, 2020

With an ever-growing CRISPR genome-editing toolbox, scientists are creating crops that can resist diseases and pests, withstand global warming, and offer better nutrition. The emergence of this technology offers a crucial opportunity for renewed public engagement around crop engineering. In order to actualize the potential of CRISPR-edited food, we must work together to create and share strategies for productive dialogue. This article identifies one area of necessary improvement in communication and public engagement.

Describing how CRISPR-edited crops are arguably more natural than GMOs, or how these crops could potentially use fewer chemicals than their GMO predecessors reinforces pervasive societal suspicions of GMOs. If we think that engineered crops will play a key role in addressing environmental and public health issues, then promoting CRISPR-edited crops at the expense of GMOs is short-sighted. Instead, we must use CRISPR as a new avenue for renewing productive discourse with the public. CRISPR offers a way to bring everyone back to the table, reintroducing voices into vital conversations that will impact us all.

The question, Is this safe? captures this tension between distancing CRISPR from GMOs in order to separate a new technology from its polarized relative, while not discarding GMOs and avoiding difficult conversations. Science communicators can use the question Is this safe? as a case study to further identify problematic practices and offer strategies for communication alternatives. Before answering this question, we must better understand the consumers decision-making process.

The processes behind engineering a CRISPR-edited crop and a GMO share many commonalities and, in some instances, lead to nearly identical outcomes .

In the wake of an incoming wave of CRISPR-edited crops, communicators have an opportunity to renew conversations surrounding what is natural, and in doing so, address concerns about naturalness and safety. For science communicators, do we suggest that CRISPR-edited crops are more natural? Do we explain how brands with a natural label dont always align with what consumers think they are buying? Or do we do we zoom out and try to separate natural from safe, so we dont tacitly buy into notions that GMOs are all unsafe?

Read the original post

View post:
Promoting CRISPR crops at the expense of GMOs is short-sighted when we need both - Genetic Literacy Project

Read More...

CollPlant Biotechnologies Signs Distribution Agreement for its Vergenix Flowable Gel Product in the Commonwealth of Independent States (CIS) -…

Tuesday, September 15th, 2020

REHOVOT, Israel, Sept. 14, 2020 /PRNewswire/ --

CollPlant (NASDAQ: CLGN) a regenerative and aesthetic medicine company, today announced that it has signed an agreement for distribution of its VergenixFlowable Gel (FG) product in six Commonwealth of Independent States (CIS) countries: Belarus, Kazakhstan, Georgia, Azerbaijan, Armenia and Uzbekistan.

The Company also reported that it has received the first order in an amount ofhundreds of thousands of U.S. dollars. Based on deal terms, CollPlant will deliver a portion of the order immediately and the remainder over the next six months. The distributor is a Swiss-headquartered pharmaceutical group of companies and the agreement is for a five-year period.

"This distribution agreement will enable new patient populations in the CIS to benefit from Vergenix FG use, which has also already elicited positive feedback in Europe for rapid recovery of chronic wounds," said Yehiel Tal, CEO of CollPlant. "We are proud of the transformative potential of our recombinant human collagen platform technology that facilitates optimal treatment options for patients and remain open to additional collaborations that will bolster commercial infrastructure for Vergenix FG as well as support for our pipeline development efforts. At the same time, we continue to strategically focus on innovative applications of our rhCollagen in medical aesthetics and 3D Bioprinting of organs and tissues. "

Vergenix FG is based on the Company's rhCollagen technology and is a wound-care product designed to treat acute and chronic hard-to-heal wounds, such as diabetic ulcers, pressure sores, surgical cuts and trauma wounds. A single applicationof the product provides an optimized treatment for the healing process until full wound closure.

Recently, a study was publishedin The Diabetic Foot Journal, Vol 23 No 2 2020, byIacopi E et al from the University Hospital in Pisa,Italy. The study demonstrated thatVergenixFG had excellent clinical outcomes inpatientswith post-surgicaldiabetic footwounds. VergenixFG has received CE marking and other regulatory approvals that allow sales and treatments in Europe, Israel and other countries.

About CollPlant

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.

Our products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and, we believe, are ushering in a new era in regenerative and aesthetic medicine.

Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In October 2018, we entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant's BioInks in the manufacture of 3D bioprinted lungs for transplant in humans.

In January 2020, we also entered into a Joint Development Agreement with 3D Systems Corporation, or 3D Systems, pursuant to which we and 3D Systems jointly develop tissue and scaffold bioprinting processes for third party collaborators. Our industry collaboration also includes the Advanced Regenerative Manufacturing Institute, or ARMI.

For more information about CollPlant, visithttp://www.collplant.com

Safe Harbor Statements

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements.Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its ability to continue as a going concern, and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the outbreak of coronavirus; the Company's expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based BioInk and products for medical aesthetics; the Company's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products in 3D Bioprinting and medical aesthetics; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the Company's reliance on third parties to conduct some or all aspects of its product manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company's strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact atCollPlant:

Eran RotemDeputy CEO & CFOTel: + 972-73-2325600Email: [emailprotected]

Sophia Ononye-Onyia, PhD MPH MBAFounder & CEO, The Sophia Consulting FirmTel: +1-347-851-8674E-mail: [emailprotected]|

SOURCE CollPlant

Home

Read the rest here:
CollPlant Biotechnologies Signs Distribution Agreement for its Vergenix Flowable Gel Product in the Commonwealth of Independent States (CIS) -...

Read More...

The timeless tale of monarch butterfly migration – centraljersey.com

Tuesday, September 15th, 2020

By Michele S. Byers

Do you ever read through old newspapers and notice that sometimes the topic and perspective are still pretty current and fresh? So much has changed in the world in recent decades, but our fascination with nature is timeless. Please enjoy the following column written 34 years ago by Dave Moore, the former executive director of the New Jersey Conservation Foundation, with a few edits to reflect more recent research and understanding:

Ever notice those bright orange and black butterflies that fly purposefully through our yards and sometimes cluster overnight in trees? They are monarch butterflies, and their flight is purposeful: They are migrating south for the winter.

The monarch butterfly migrates all the way to the mountains of central Mexico, often from as far as New Jersey, New England or nearby Canada. This is one of the most amazing migration stories in nature; one in which the route has been partially realized by naturalists for a long time, but fully understood only a decade ago with the discovery of the long-sought wintering place of the monarchs.

Researchers are still adding to the story. For example, it was at first thought that the same butterflies returned to New Jersey a year after their southward migration. Its now realized that its the grandchildren or even the great-great-great-great grandchildren who come back to the northeast.

Science is still a long way from learning how the butterflies have managed to arrive at the same small area of Mexico over millions of years. But they have, and during their migrations they even congregate on certain trees at specific locations, year after year. These way-points in themselves are popular tourist attractions, as is the Mexican destination.

One butterfly tree of which I am aware stands in Island Beach State Park near Barnegat Lighthouse, and is decorated by thousands of monarchs each autumn. When science finally solves the riddle of the monarchs migration, I suppose a little more magic will have gone out of our lives.

But the danger of lost magic is greater for another reason, and not just in terms of monarch migrations. Can you imagine a world without our common songbirds, or minus many of the larger birds that annually make long round trips south and north?

While we protect them up here, their habitats are being bulldozed and burned away in South America as many countries destroy forests to make way for new development.

The monarchs are lucky; Mexico has set aside their wintering place for tourist and scientific reasons. Not so with the birds.

There are so many plants and animals we know nothing about that are becoming extinct before we can really study them. Fewer than a tenth of the plants, insects and animals on earth have been identified. The rate of extinction is speeding up due to peoples blind exploitation of the environment.

We must do much more to protect reserves where plants and animals can survive in the hope of someday revealing exciting secrets for medicines and foods to help us survive. We must also do a better job of regulating our own chemicals so they dont do us and other life forms in.

Bugs and weeds dont attract as much attention as whales and pandas, but they are equally important in the scheme of things.

Monarch butterflies feed only on milkweed, for example. If we lose the milkweed, we lose the butterfly. And by the way, monarchs have the ability to turn milkweed juice into a toxic substance that has taught predators to avoid them. Other butterflies have learned to mimic monarchs to get the same protection.

With all this loss of life-forms, and with our growing interest in genetic engineering, genetic diversity becomes more important, even as its being threatened. That means we must protect natural areas worldwide, protect native plants and animals, and learn more about the effects of our pesticides and other chemicals before its too late.

You have read about possible links between the herbicide Agent Orange and cancer. Agent Orange contains 2,4-D, a common herbicide. Recent studies point toward a connection between 2,4-D and three cancers in humans, including Hodgkins disease.

Given that everything is connected to everything else, we need to proceed carefully. Not only do we not know who lives in the world with us, but we dont even know what the majority of chemical substances we manufacture are doing to them or us.

Back to Michele: Since Daves nature column was written in September 1986, more research has been done on monarch butterfly migration, as well as on the harmful impacts of many chemical herbicides and pesticides, not just Agent Orange.

The annual journey of monarch butterflies still amazes. In Cape May, the New Jersey Audubon Society now monitors monarch butterflies each fall as they congregate on the peninsula in preparation for their flight across the Delaware Bay. If you get a chance this fall, be sure to visit to see migrating birds and butterflies.

Michele S. Byers is the executive director of the New Jersey Conservation Foundation, Far Hills. She may be reached at info@njconservation.org

Link:
The timeless tale of monarch butterfly migration - centraljersey.com

Read More...

Novavax to Participate in Upcoming Investor Conferences – GlobeNewswire

Tuesday, September 15th, 2020

GAITHERSBURG, Md., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will participate in five upcoming investor conferences. A topic of discussion will be Novavax COVID-19 vaccine candidate, NVX-CoV2373.

Conference details are as follows:

Citi 15th Annual BioPharma Virtual Conference

H.C. Wainwright 22nd Annual Global Investment Conference

Cantor Virtual Global Healthcare Conference

Morgan Stanley Virtual 18th Annual Global Healthcare Conference

Leerink CyberRx Series: Vaccine Forum

A replay of the presentations will also be accessible under the Investors/Events sectionwww.novavax.com.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

InvestorsSilvia Taylor and Erika Trahanir@novavax.com240-268-2022

MediaBrandzone/KOGS CommunicationEdna Kaplankaplan@kogspr.com617-974-8659

See the article here:
Novavax to Participate in Upcoming Investor Conferences - GlobeNewswire

Read More...

Investor Interest in Meat Alternative Biotechs… – Labiotech.eu

Tuesday, September 15th, 2020

In recent times, an unexpectedly large number of investments have closed in biotech startups offering sustainable meat alternatives. Why are investors flocking to this field amid a raging pandemic?

Traditional agriculture is a major polluter, especially in the case of meat production. The highest estimations place its share of global greenhouse gas emissions at up to 20%. In an effort to meet the growing demand for sustainability, many biotech companies are developing less energy-intensive sources of protein via fermentation and plant products.

In spite of the financial chaos resulting from the Covid-19 pandemic this year, big money has gone to biotech startups producing meat alternatives. In the US, the prime example is Impossible Foods, which genetically engineers yeast to give plant-based meat alternatives a realistic meat flavor. Last month, Impossible Foods raised a Series G round of 169M ($200M) to accelerate the commercialization of its technology globally.

In Europe, a similar pattern is emerging. The Finnish startup Solar Foods raised a total of 18.5M in a Series A last week. By late 2022, the company plans to launch a protein food ingredient grown from bacteria using electricity, carbon dioxide, water, and nitrogen.

Add to the mix an 8.5M Series A round raised by the German startup Mushlabs, which grows protein-rich mushroom roots via fermentation, and a 19.5M fundraise by Lever VC, a venture firm financing companies developing protein alternatives. Within just a few months, the field has started to blossom.

According to Albrecht Wolfmeyer, International & National Head of the food startup incubator ProVeg, these rounds are just the tip of the iceberg.

Think of precision fermentation and companies like Legendairy in Germany, Remilk in Israel, or Perfect Day in the US, which just raised 254.3M ($300M) in its Series C, Wolfmeyer said. In Europe, the investment rounds are still way smaller but they are growing along with the enthusiasm.

There are several reasons behind this funding surge, said Nick Cooney, founder and Managing Partner of Lever VC. For example, more startups in the field are emerging than ever. And as the first wave of products establish themselves in the market, investors get encouraged to join the party.

In my freezer, I have pints of ice cream from the grocery store that have real whey in them produced via fermentation, without the need for live animals the whey comes from US-based Perfect Day, noted Cooney.

Pasi Vainikka, co-founder and CEO of Solar Foods, likened the situation to the rise of the digital tech sector at the turn of the 21st century. The development of the first mobile devices was basically laying the foundations for a new industrial sector in the global economy, Vainikka explained. I can see the same with food now.

What is most remarkable is that all of this progress comes in spite of the fact that the pandemic threatens economic recessions around the world.

Covid-19 didnt turn out to be as destructive to the food innovation and investment ecosystem as we first thought, said Wolfmeyer. Investors were not as reluctant as expected but mostly rather bullish.

As food companies, they are all deemed essential businesses so never had to pause operations or stop going into the lab, added Cooney.

In fact, dramatic rises were seen in the sales of vegan and plant-based alternatives to meat and dairy products during the pandemic, and they remain high. This surge in demand even outweighed increasing sales of traditional meat and dairy products seen during the hamster shopping season in Spring, said Cooney.

While the field in general seemed robust in the face of pandemic uncertainty, Wolfmeyer and Cooney saw some food biotech startups falling through the gaps, especially those that depended on providing food services. The ProVeg Incubator, for example, advised early-stage startups on how to tighten their belts and apply for governmental support.

What has also become clear this year is that startups making meat alternatives could also strengthen protein supplies during the uncertain times of the pandemic.

Weve seen significant disruptions in the conventional meat supply chain, said Caroline Bushnell, Associate Director of Corporate Engagement at the Good Food Institute in a July article by Fast Company. Companies using fermentation- and cell-based production methods could better automate the meat production process and make it more resilient to Covid-19 shutdowns.

Politicians seem to be thinking along similar lines. Theyre opening up new ways to maintain a steady protein supply in the face of future disruption.

Weve also seen in the past six months governments working to move forward with further establishing the regulatory pathway for biotech-based alternative protein products, as a way to diversify the protein supply chain, said Cooney.

The EU has also recently allocated a 550B recovery fund with a focus on green initiatives such as making agriculture more sustainable. These funds could trickle down to biotechs working in the food and cellular agriculture space, though some worry about the lack of precise guidelines on how to spend this funding.

One of the limitations of this growing movement is the strict stance of the European Commission on products containing genetically modified (GM) ingredients. Impossible Foods is currently awaiting an EU decision on whether it will be able to commercialize its products on European soil. Some believe the company might substitute its meat flavoring for a non-GM alternative to speed up the approval.

For many food biotech startups in Europe, though, this anti-GM environment is no hindrance. For example, Solar Foods doesnt require the use of genetically modified organisms, since it uses a natural strain of bacteria found in soil. Similarly, Mushlabs grows mushroom roots in a fermentation system with no need for genetic engineering.

In general, the main obstacles standing in the way of getting lab-grown food into the mainstream are pricing, quality, and public image. Affordable pricing will take time while the startups scale up their technology. Food quality and public image could still have an uphill struggle given the historically mixed reception of fake meat.

Maybe its for companies like ourselves now to prove new products are good enough so that they dont taste like in the past, Vainikka said.

So it must taste good and be equal, or better than, what we have today. Then people will naturally go for it.

Images from Elena Resko and Solar Foods

Read more:
Investor Interest in Meat Alternative Biotechs... - Labiotech.eu

Read More...

Neogene Therapeutics Raises $110 Million Series A Financing to Develop Next-Generation Fully Personalized Neo-Antigen T Cell Receptor (TCR) Therapies…

Tuesday, September 15th, 2020

Sept. 14, 2020 12:00 UTC

Series A Financing led by EcoR1 Capital, Jeito Capital and Syncona with continued support of strategic seed investors Vida Ventures, TPG and Two River

Neogenes proprietary technology platform identifies specific T cell receptor (TCR) genes from routine tumor samples using state-of-the-art synthetic biology tools

Co-founded by renowned T cell engineering expert Ton Schumacher, Ph.D. and Carsten Linnemann, Ph.D. with investment from cell therapy industry veteran Arie Belldegrun, M.D. FACS

NEW YORK & AMSTERDAM--(BUSINESS WIRE)-- Neogene Therapeutics, Inc., a pre-clinical stage biotechnology company pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer, today announced that it has raised $110 million in a Series A financing. The financing was co-led by EcoR1 Capital, Jeito Capital and Syncona, with participation from Polaris Partners and Pontifax. Seed investors Vida Ventures, TPG and Two River also participated in the round.

Neogene, a Two River company, was founded in 2018 by a team of world-class cell therapy experts to advance the development of neo-antigen T cell therapies. Carsten Linnemann, Ph.D., Chief Executive Officer of Neogene, and Ton Schumacher, Ph.D., Principal Investigator at the Netherlands Cancer Institute, Oncode Institute and 2020 recipient of the Dutch Research Councils Stevin Award co-founded the Company with individual investments by cell therapy industry veterans Arie Belldegrun, M.D. FACS, founder of Kite Pharma, Inc. and Co-Founder and Executive Chairman of Allogene Therapeutics, Inc. and David Chang, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Allogene. Dr. Linnemann and Dr. Schumacher previously co-founded T-Cell Factory B.V., a company acquired by Kite Pharma in 2015.

Dr. Schumacher, an internationally leading immunologist in the areas of neo-antigen biology and T cell engineering, developed the seminal concepts of Neogenes proprietary technology. Neogenes platform allows for the isolation of neo-antigen specific TCR genes from tumor biopsies that are routinely obtained from cancer patients during treatment. The tumor-infiltrating lymphocytes (TIL) obtained by these tumor biopsies frequently express TCRs specific for mutated proteins found in cancer cells (neo-antigens). The Companys proprietary technology uses state-of-the-art DNA sequencing, DNA synthesis and genetic screening tools to identify such neo-antigen specific T cell receptor genes within tumor biopsies with high sensitivity, specificity and at scale. The isolated TCR genes are subsequently engineered into T cells of cancer patients to provide large numbers of potent T cells for therapy.

Neogene is committed to forging a path for new fully personalized engineered T cell therapies in solid cancer that are redirected towards neo-antigens found on cancer cells, said Dr. Linnemann. While engineered T cell therapies have transformed the treatment paradigm for patients with hematologic malignancies, the industry has struggled to translate this success to the enormous unmet need in patients with advanced solid tumors. We believe that through a fully individualized approach using patient-specific TCRs to target neo-antigens, engineered T cell therapy can become broadly accessible to these patients. We are excited that our vision is shared by an outstanding syndicate of marquee investors, who have a deep understanding of and commitment towards the development of novel cell therapies in oncology.

Neo-antigens represent ideal targets for cancer therapy, as they inevitably arise from DNA mutations that enable tumor development in the first place. Further supporting this concept is clear, correlative evidence linking T cell reactivity against neo-antigens with tumor regression in several patients, said Dr. Schumacher. The Neogene platform makes it possible to exploit the neo-antigen reactive TCRs that are present in TIL without a requirement for viable tumor material. In addition, its syn-bio based approach offers major advantages with respect to standardization and scalability and will be critical to achieve our goal of bringing personalized engineered T cell therapies to patients.

In this Series A financing, Neogene expands its distinguished investor base with leading health-care investors from both the U.S. and Europe. For the seed-investors Vida Ventures, TPG and Two River, Neogene marks the second major collaboration in the cell therapy space after the launch of Allogene Therapeutics in 2018. Neogenes seed-financing in 2019 enabled the Company to achieve proof-of-concept for its neo-antigen technology platform and built on the respective expertise of Vida Ventures, Two River and TPG in the gene and cell therapy space.

We believe that Neogenes technology and therapeutic approach has the potential to become a game changer for the treatment of cancer, said Oleg Nodelman, Founder and Managing Director of EcoR1 Capital. We are impressed by the bold vision of the management team and are thrilled to support Neogene as it advances its mission of developing novel therapies for cancer patients in need.

Neogenes approach perfectly aligns with Jeitos mission. Jeito was launched recently to support new and established entrepreneurs aspiring to help patients in need by pioneering novel, ground-breaking medicines underlined by highest quality innovation, said Rafale Tordjman, Founder and Chief Executive Officer at Jeito Capital. We are delighted to welcome Neogene as the first investment into our new portfolio.

We are excited to partner with the outstanding Neogene team, said Martin Murphy, Chief Executive Officer of Syncona. Neogenes technology offers a radically innovative approach to utilize the therapeutic potential of TIL cells by employing state-of-the-art TCR engineering and synthetic biology technologies. Facilitated by the Series A, Neogene intends to further develop its technology with growing offices in Amsterdam and the U.S. with the goal to initiate Phase I clinical studies in 2022.

About Neogene Therapeutics

Neogene Therapeutics, Inc. is a pre-clinical stage biotechnology company pioneering development of next-generation, fully personalized engineered T cells therapies for a broad spectrum of cancers. The Companys engineered T cells target mutated proteins found in cancer cells due to cancer-associated DNA mutations, or neo-antigens, that render tumor cells vulnerable to detection by T cells. Neogenes proprietary technology platform aims to identify TCR genes with specificity for neo-antigens from tumor biopsies. Neogenes novel approach intends to deliver a tailored set of TCR genes for each individual patient, which will be engineered into patient-derived T cells directing them towards neo-antigens in tumor cells, with the goal of providing a fully personalized engineered T cell therapy for cancer.

For more information, please visit http://www.neogene.com, and follow Neogene Therapeutics on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005309/en/

Read the original here:
Neogene Therapeutics Raises $110 Million Series A Financing to Develop Next-Generation Fully Personalized Neo-Antigen T Cell Receptor (TCR) Therapies...

Read More...

‘Moondust’ carnation uses genetic engineering to achieve its blue color – Batesville Daily Guard

Wednesday, September 2nd, 2020

The search for flowers with shades and hues different from what nature provides has been ongoing since humankind discovered the intricacies of plant breeding. But there are limits to the color range that can be achieved using traditional breeding techniques. For example, blue pigments are lacking from many plants.

But science now allows breeders to extend the natural range of colors, using genetic engineering. Moondust carnation, first grown commercially in 1997, is a mini-carnation with purple-mauve flowers that gets its blue color from petunia genes grafted into the DNA of the carnation.

Twelve scientists at an Australian company called Florigene labored for a decade to isolate the gene responsible for blue color in petunia and then transfer it into the carnation. To date, they have released five carnations with the "Moon" prefix, all with varying shades of mauve, blue, violet or purple.

Flower color expression is caused by the subtle blending of pigments contained in the vacuoles (think of vacuoles as storage closets in the cell) and plastid bodies (think of these as like chlorophyll, but with a color other than green) suspended in the cell sap. Just as the man at the paint store blends different pigments to a neutral base to color paint, flower color is caused by the subtle blends of several pigments.

But roses, carnations, lilies and orchids all lack a class of blue pigments called delphinidins, named after the violet-blue we see in delphinium. The gene for delphinidin production is what the Floragene scientists removed from petunia and transferred to the carnation.

The development of the blue carnation was not the primary goal of the research team; no, they wanted to make a blue rose. But, transplanting genes is easy to say but hard to do in the lab, so they honed their techniques on carnations a much easier species to manipulate than roses. The team has not given up on the idea of a blue rose, but it is now exploring the possibility of inserting genes from sea anemones into the rose to create the blue shades. The petunia gene didnt work in roses.

You may be thinking by now, "Ive seen blue carnations for years. Whats new about this?" True, there have been blue carnations available since the 1970s, but their blue was due to food color, not natural pigments.

Scott Admire with Little Rocks United Wholesale Florists said they used to dye white carnations shipped in from cut flower growers in Central and South America. The carnations would have to be shipped in as a "dry pack," exposed to neither water nor the floral preservative silver thiosulphate. The carnations would then suck in the pigment-laden water with a good deal of it ending up in the petals, turning the flowers the shade of blue you see atop a decorated birthday cake.

Carnation flowers sometime get "sleepy" and curl up. This is caused by the production of a plant growth hormone called ethylene, which is a part of the natural aging process in flower development. Cut flower growers combat this by using the silver-containing floral preservative that stops the production of ethylene. Floragene scientists are currently seeking clearance to introduce a line of plants that do not produce ethylene, thus eliminating the need for the silver thiosulphate treatment.

This ethylene-blocking technology is not new, and in fact, an Arkansas boy Dr. Randy Woodson from Fordyce and now a dean at Purdue University responsible for the agricultural research program patented a technique in the early 1990s using the "anti-sense" procedure. Using this technique, the gene for ethylene production is switched end-for-end in the DNA strand, rendering it inoperative. It's not clear if the Floragene technique uses this same "anti-sense" technology.

Are the scientists involved in creating genetically modified plants playing God? What about environmental concerns? For the former question, my theological credentials are suspect, but to the latter question I feel confident there is no significant environmental risk in growing blue carnations. The plants are essentially pollen sterile and carnations are harvested in the tight-bud stage, so the likelihood of out-crossing with wild carnations is remote.

See the original post:
'Moondust' carnation uses genetic engineering to achieve its blue color - Batesville Daily Guard

Read More...

Chile poised to tackle food shortages and climate change with ‘Golden Apple’ and other CRISPR-edited crops – Genetic Literacy Project

Wednesday, September 2nd, 2020

Chiles intense political unrest exacerbated by months of COVID-19 quarantine has temporarily overshadowed a relentless environmental, farming crisis: an intense droughtthe worst in the countrys history now moving into its tenth year. The last few months have offered a temporary respite, with rains reaching average levels. But Chile is in desperate need of longer term responses to worsening climactic conditions that threaten to intensify existing food shortages and jeopardize the nations vital agriculture industry.

Biochemist and president of the Chilean Society of Plant Biology Dr. Claudia Stange believes she is part of the solution. Climate change is here to stay, she believes, so its time to mobilize genetic technology and adapt. Stange and her colleagues at the University of Chile are gene editing new varieties of apple, kiwi and tomato to improve their nutritional content and resistance to drought and saline soils.

This is not the first major effort to harness CRISPR and and transgenics (GMOs) to improve the environmental hardiness or nutritional content of crops. Golden Rice, recently approved for roll out in the Philippines after more than two decades of stops and starts, is a humanitarian project initiated by university scientists to generate a GMO rice high in beta carotene, a precursor to vitamin A. Vitamin A is largely absent from the diets of millions of people in southeast Asia. This deficiency is to blame for 250 000to500 000 cases of childhood blindness every year, with half of them ending in death, according to the World Health Organization (WHO).

Dr. Stanges first major project, launched in 2011 and financed with public funds, had a similar goal to that of Golden Rice: to develop an apple genetically modified to synthesize carotenoids. Due to technical constraints and an inability to get similar results using conventional plant breeding methods, genetic engineering was recognized as the best tool for producing what came to be known as the Golden Apple.

If the project is successful, it could be a major economic and health coup for Chile. It is the worlds fourth largest exporter of apples, so improving the nutritional profile of exported varieties would boost its apple industry and benefit consumers worldwide, Stange told me:

Today consumers are looking for foods that are functional, that means, with a higher content of antioxidants, vitamins, etc. Those characteristics would be fulfilled by our apples with the highest content of carotenoids -which are provitamin A molecules- and antioxidants that counteract various diseases and aging.

The Golden Apple project successfully developed transgenic lines of biofortified apple seedlings years ago, but commercializing it was another matter. Although the development and cultivation of GMO crops like corn, soybean and canola is routine in South American countries including Brazil and Argentina, progress in Chile has been slowed by regulatory obstacles and political opposition to recombinant DNA technology.

Although the country imports large quantities of grain harvested from GMO plants in other countries, Chiles biotech regulations would have prohibited the commercialization of home-grown Golden Apples. Chile currently exports locally cultivated GMO corn, soybean and canola seeds, mostly to the United States, Canada and South Africa. Facing regulatory obstacles, financing for the Golden Apple project dried up by 2014, bringing the research to an unceremonious end.

But the Golden Apple was recently given a faint breath of life. Stange was blocked in bringing her bio-fortified apple to market because it was transgenicit involved the transfer of genes from one species to another. But with advances in gene editing, specifically CRISPR, a technique that has fueled development of a new generation of improved crops, an apple with similar traits could be developed without the use of foreign genes. Chile is now growing gene-edited cereal, vegetable and fruit crops in field trials, although there is as yet no path to commercialization

There are crucial differences between gene editing and older genetic modification technology, Stange explained:

In GMOs, one or more genes from another plant or organism are inserted into a plant of interest so that gene, when expressed, gives it beneficial traits the original plant didnt havefor example, the production of provitamin-A, resistance to drought or pathogens.

In gene editing, molecular biology strategies are also used, but in this case its to avoid that a specific gene is expressed in the plant of interest. By specifically editing or mutating that gene, the plant presents positive traits that it didnt previously have.They [genetic modification and gene editing] are two strategies that seek the same end. Only in the last one there is no exogenous DNA material. For this reason, its more easily accepted in countries where GMOs arent.

After Argentina became the first country to green light gene editing research for agricultural purposes in 2015, Chile followed in 2018 with a similar rule that allows the techniques to be used as long as no transgenes are added to the target plant. Brazil, the United States, Australia, Canada, Colombia, Israel, Japan and other countries subsequently enacted their own gene editing regulations.

Building on their earlier research, Stange and her team expanded work on Golden Apples in 2018, but this time with CRISPR. These next-generation apples will not only provide high levels of Vitamin A and more antioxidants, they will resist browning, which reduces food wastethe same effect achieved by the Arctic apple, developed using a different genetic engineering technique in Canada.

To date we are selecting apple seedlings that have the desired traits: this means, that they have edited the genes of interest, that produce less browning, higher carotenoid content and that are not GMOs. At the end of the year we will be able to have the first seedlings to be transferred to Los Olmos nursery, where they will continue the evaluation in the greenhouse and field.

In the meantime, our team will continue to generate and select more lines so as to have a large number of plants that allows us to choose the best ones when they produce fruit, Stange adds about the project financed by CORFO and carried out in association with the Biofrutales Consortium and Vivero Los Olmos.

These apples wont reach our tables for a while, however. Stange estimated that it will take five years to select the best genotypes of edited apple trees, before taking them to field production.

In March 2020, Stanges laboratory launched another effort designed to address the impact of climate change on regional agricultural production: Proyecto Anillo (Ring Project) Plant Abiotic Stress for a Sustainable Agriculture (PASSA), financed by ANID. The project was developed with the help of Drs. Michael Handford and Lorena Norambuena at the University of Chiles Center for Molecular Biology, in association with Dr. Juan Pablo Martnez from the Institute of Agricultural Research (INIA) and Dr. Ricardo Tejos from Arturo Prat University.

PASSA aims to develop drought- and salt-tolerant tomato and kiwi rootstocks with CRISPR, directly addressing the water emergency situation that is gradually worsening in Chile. Tomatoes are the most consumed vegetable globally and in Chile. The South American nation is also the third largest kiwi exporter after New Zealand and Italy. Shielding these crops from increasing water scarcity and desertification is therefore an essential objective.

According to Stange:

Tomato and kiwi crops are very relevant to the countrys economy. In the case of tomato, well study the traits of the Poncho negro, a Chilean variety originating in the Azapa Valley (Arica) that has a high salinity tolerance and whose genetic breeding would increase the productivity of tomato 7742 (seminis), the most produced and marketed variety in Chile. [I]t can be grafted onto Poncho Negro.

Regarding kiwis, we will seek to increase salinity and drought tolerance of varieties used as rootstocks, to improve the productivity of Hayward commercial kiwi plants.

While the Golden Apple project requires established, fruit-producing trees, fruits are not needed to grow young kiwi and tomato plants; they can be evaluated at the laboratory and greenhouse level under conditions of drought and salinity.

Unfortunately, quarantine has forced the researchers to prioritize bioinformatic activities over laboratory experiments, delaying the project for up to six months. With this setback, it could take three years to edit the plants and evaluate them in field trials.

There is another technical obstacle that must be surmounted as well: adapting crops originating in other parts of world to local conditions:

Currently the new varieties are acquired by paying royalties to foreign companies.

This implies bringing those varieties [to Chile] and waiting a few seasons until they adapt to our edaphoclimatic conditions, with the expectation that they will produce the fruits as they are produced where they were generated. This is a risk. In our case, they are varieties already produced and marketed in Chile to which we will add these new traits.

Stange believes that the future for genetically engineered fruit, vegetables and grains will be brighter than the recent past. GMO crops are gradually being embraced and there is a growing global trend outside of precautionary-obsessed Europe towards relatively lax regulatory oversight of CRISPR gene editing. That could allow for the commercialization of new consumer-focused crop varieties, she says.

The benefit that these biofortified plants bring will overcome the conceptual reluctance to GMOs, especially in countries that appreciate the health value that these types of improved products give them. The need will make countries join the incorporation of GM and edited plant crops.

Daniel Norero is a science communications consultant and fellow at the Cornell Alliance for Science. He studied biochemistry at the Catholic University of Chile. Follow him on Twitter @DanielNorero

Read the original here:
Chile poised to tackle food shortages and climate change with 'Golden Apple' and other CRISPR-edited crops - Genetic Literacy Project

Read More...

The promise and perils of synthetic biology take center stage in a fast-paced new Netflix series – Science Magazine

Wednesday, September 2nd, 2020

Christian DitterNetflix6 episodes

The first season of the Netflix series Biohackers, consisting of six episodes released on the streaming platform on 20 August, tells a fictional tale centered around the sociotechnological movement known as do-it-yourself (DIY) biology, in which amateurs, professionals, anarchists, and civic-minded citizens push the boundaries of mainstream biology. The shows main characters include a wealthy biopharmaceutical executive, a group of medical students, a number of stereotypical biohackers making animals glow and plants play music, and a community of transhumanists intent on modifying their bodies for seemingly impractical endeavors.

Whereas biological experimentation was once the sole domain of trained professionals in well-stocked and well-funded institutional labs, the field has been democratized by the emergence of the open-source movement, plummeting sequencing costs, greater access to reagents and devices, the proliferation of online resources, and the emergence of tools and methodologies that enable nonexperts to genetically engineer organisms without years of professional training. [Valid concerns regarding some of the activities associated with the DIY bio community have been voiced by the Presidential Commission for the Study of Bioethical Issues (1).]

Medical student Mia Akerlund (right) meets biohackers pushing the boundaries of mainstream biology.

The show follows Mia Akerlund (played by Luna Wedler), a first-year medical student vying for a position at a prestigious biopharmaceutical firm headed by celebrated professor Tanja Lorenz (Jessica Schwarz). Akerlund and Lorenz clearly have some shared history, as well as their own secrets, although viewers are not privy to the details of either at the start of the series. For much of the first episodes, the relationship between these two enigmatic characters is revealed slowly through both flash-forwards and flashbacks. But we know that a big reveal is coming; the programs official description teases a secret so big it could change the fate of humanity.

Throughout the seasons six fast-paced episodes, the viewer is exposed to technologies and techniques that would be familiar to many professional scientists. And while the time frames of the various experiments conducted are often compressed for dramatic effect, Christian Ditterthe shows creator, writer, director, and showrunnergoes out of his way to present complex science as accurately as possible. In one montage, for example, we watch various biohackers, some with better aseptic technique than others, add reagents to microcentrifuge tubes, load polymerase chain reaction machines, and examine gels to assess whether they have accurately created a desired genomic sequence. In another scene, a student suffering from a degenerative disease seeks to develop his own cure in a secret lab, where he can work without burdensome oversight. The student injects himself with an unknown liquid, his purported cure. Here, the shows dialogue surrounding the cure and its antidote (to be administered if things go wrong) offers insight into how RNA interference therapies work.

But the show also serves as a pedagogical vehicle to raise many timely and interesting ethical, legal, and social concerns. From bioluminescent mammals to the collection of genetic material for clinical trials, the series storyline highlights how cavalierly we sometimes approach genomic data and genetic engineering. Later episodes depict even more egregious examples of biohacking, including organisms modified to transmit viruses as efficiently as possible. At one point, a character suggests that the ends of her research justify the experimental means, even when her methods demonstrate a gross disregard for test subjects who may suffer as a result.

The show also offers insight into some of the motivations that drive DIY biology efforts. For example, in one scene, a confidant of Akerlund expresses dismay that Lorenz is willing to sell a cheaply acquired drug to desperate patients for inflated prices. Such frustrations are what drive many citizens operating outside traditional institutions to develop their own pharmaceutical solutions.

It is ironic that Biohackers is set in Germany, one of the few places where genetic engineering experimentation outside of licensed facilities is illegal and can result in a fine or even imprisonment (2). Yet, given all that transpires in the show, one is left with the sense that such measures maybe justified.

References and Notes:1. Presidential Commission for the Study of Bioethical Issues, New directions: The ethics of synthetic biology and emerging technologies (2010).2. Sections 8 and 39 of the German Genetic Engineering Act [Gentechnikgesetz (GenTG)].

The reviewer is at Zvi Meitar Institute for Legal Implications of Emerging Technologies, Herzliya, Israel, and the Department of Molecular Biophysics and Biochemistry, Yale University, New Haven, CT, USA.

Read the original post:
The promise and perils of synthetic biology take center stage in a fast-paced new Netflix series - Science Magazine

Read More...

How Groups of Cells Cooperate to Build Organs and Organisms – The Scientist

Wednesday, September 2nd, 2020

Efforts to use regenerative medicinewhich seeks to address ailments as diverse as birth defects, traumatic injury, aging, degenerative disease, and the disorganized growth of cancerwould be greatly aided by solving one fundamental puzzle: How do cellular collectives orchestrate the building of complex, three-dimensional structures?

While genomes predictably encode the proteins present in cells, a simple molecular parts list does not tell us enough about the anatomical layout or regenerative potential of the body that the cells will work to construct. Genomes are not a blueprint for anatomy, and genome editing is fundamentally limited by the fact that its very hard to infer which genes to tweak, and how, to achieve desired complex anatomical outcomes. Similarly, stem cells generate the building blocks of organs, but the ability to organize specific cell types into a working human hand or eye has been and will be beyond the grasp of direct manipulation for a very long time.

But researchers working in the fields of synthetic morphology and regenerative biophysics are beginning to understand the rules governing the plasticity of organ growth and repair. Rather than micromanaging tasks that are too complex to implement directly at the cellular or molecular level, what if we solved the mystery of how groups of cells cooperate to construct specific multicellular bodies during embryogenesis and regeneration? Perhaps then we could figure out how to motivate cell collectives to build whatever anatomical features we want.

New approaches now allow us to target the processes that implement anatomical decision-making without genetic engineering. In January, using such tools, crafted in my lab at Tufts Universitys Allen Discovery Center and by computer scientists in Josh Bongards lab at the University of Vermont, we were able to create novel living machines, artificial bodies with morphologies and behaviors completely different from the default anatomy of the frog species (Xenopus laevis) whose cells we used. These cells rebooted their multicellularity into a new form, without genomic changes. This represents an extremely exciting sandbox in which bioengineers can play, with the aim of decoding the logic of anatomical and behavioral control, as well as understanding the plasticity of cells and the relationship of genomes to anatomies.

Deciphering how an organism puts itself together is truly an interdisciplinary undertaking.

Deciphering how an organism puts itself together is truly an interdisciplinary undertaking. Resolving the whole picture will involve understanding not only the mechanisms by which cells operate, but also elucidating the computations that cells and groups of cells carry out to orchestrate tissue and organ construction on a whole-body scale. The next generation of advances in this area of research will emerge from the flow of ideas between computer scientists and biologists. Unlocking the full potential of regenerative medicine will require biology to take the journey computer science has already taken, from focusing on the hardwarethe proteins and biochemical pathways that carry out cellular operationsto the physiological software that enables networks of cells to acquire, store, and act on information about organ and indeed whole-body geometry.

In the computer world, this transition from rewiring hardware to reprogramming the information flow by changing the inputs gave rise to the information technology revolution. This shift of perspective could transform biology, allowing scientists to achieve the still-futuristic visions of regenerative medicine. An understanding of how independent, competent agents such as cells cooperate and compete toward robust outcomes, despite noise and changing environmental conditions, would also inform engineering. Swarm robotics, Internet of Things, and even the development of general artificial intelligence will all be enriched by the ability to read out and set the anatomical states toward which cell collectives build, because they share a fundamental underlying problem: how to control the emergent outcomes of systems composed of many interacting units or individuals.

Many types of embryos can regenerate entirely if cut in half, and some species are proficient regenerators as adults. Axolotls (Ambystoma mexicanum) regenerate their limbs, eyes, spinal cords, jaws, and portions of the brain throughout life. Planarian flatworms (class Turbellaria), meanwhile, can regrow absolutely any part of their body; when the animal is cut into pieces, each piece knows exactly whats missing and regenerates to be a perfect, tiny worm.

The remarkable thing is not simply that growth begins after wounding and that various cell types are generated, but that these bodies will grow and remodel until a correct anatomy is complete, and then they stop. How does the system identify the correct target morphology, orchestrate individual cell behaviors to get there, and determine when the job is done? How does it communicate this information to control underlying cell activities?

Several years ago, my lab found that Xenopus tadpoles with their facial organs experimentally mixed up into incorrect positions still have largely normal faces once theyve matured, as the organs move and remodel through unnatural paths. Last year, a colleague at Tufts came to a similar conclusion: the Xenopus genome does not encode a hardwired set of instructions for the movements of different organs during metamorphosis from tadpole to frog, but rather encodes molecular hardware that executes a kind of error minimization loop, comparing the current anatomy to the target frog morphology and working to progressively reduce the difference between them. Once a rough spatial specification of the layout is achieved, that triggers the cessation of further remodeling.

The deep puzzle of how competent agents such as cells work together to pursue goals such as building, remodeling, or repairing a complex organ to a predetermined spec is well illustrated by planaria. Despite having a mechanistic understanding of stem cell specification pathways and axial chemical gradients, scientists really dont know what determines the intricate shape and structure of the flatworms head. It is also unknown how planaria perfectly regenerate the same anatomy, even as their genomes have accrued mutations over eons of somatic inheritance. Because some species of planaria reproduce by fission and regeneration, any mutation that doesnt kill the neoblastthe adult stem cell that gives rise to cells that regenerate new tissueis propagated to the next generation. The worms incredibly messy genome shows evidence of this process, and cells in an individual planarian can have different numbers of chromosomes. Still, fragmented planaria regenerate their body shape with nearly 100 percent anatomical fidelity.

Permanent editingof the encoded target morphology without genomic editing reveals a new kind of epigenetics.

So how do cell groups encode the patterns they build, and how do they know to stop once a target anatomy is achieved? What would happen, for example, if neoblasts from a planarian species with a flat head were transplanted into a worm of a species with a round or triangular head that had the head amputated? Which shape would result from this heterogeneous mixture? To date, none of the high-resolution molecular genetic studies of planaria give any prediction for the results of this experiment, because so far they have all focused on the cellular hardware, not on the logic of the softwareimplemented by chemical, mechanical, and electrical signaling among cellsthat controls large-scale outcomes and enables remodeling to stop when a specific morphology has been achieved.

Understanding how cells and tissues make real-time anatomical decisions is central not only to achieving regenerative outcomes too complex for us to manage directly, but also to solving problems such as cancer. While the view of cancer as a genetic disorder still largely drives clinical approaches, recent literature supports a view of cancer as cells simply not being able to receive the physiological signals that maintain the normally tight controls of anatomical homeostasis. Cut off from these patterning cues, individual cells revert to their ancient unicellular lifestyle and treat the rest of the body as external environment, often to ruinous effect. If we understand the mechanisms that scale single-cell homeostatic setpoints into tissue- and organ-level anatomical goal states and the conditions under which the anatomical error reduction control loop breaks down, we may be able to provide stimuli to gain control of rogue cancer cells without either gene therapy or chemotherapy.

During morphogenesis, cells cooperate to reliably build anatomical structures. Many living systems remodel and regenerate tissues or organs despite considerable damagethat is, they progressively reduce deviations from specific target morphologies, and halt growth and remodeling when those morphologies are achieved. Evolution exploits three modalities to achieve such anatomical homeostasis: biochemical gradients, bioelectric circuits, and biophysical forces. These interact to enable the same large-scale form to arise despite significant perturbations.

N.R. FULLER, SAYO-ART, LLC

BIOCHEMICAL GRADIENTS

The best-known modality concerns diffusible intracellular and extracellular signaling molecules. Gene-regulatory circuits and gradients of biochemicals control cell proliferation, differentiation, and migration.

BIOELECTRIC CIRCUITS

The movement of ions across cell membranes, especially via voltage-gated ion channels and gap junctions, can establish bioelectric circuits that control large-scale resting potential patterns within and among groups of cells. These bioelectric patterns implement long-range coordination, feedback, and memory dynamics across cell fields. They underlie modular morphogenetic decision-making about organ shape and spatial layout by regulating the dynamic redistribution of morphogens and the expression of genes.

BIOMECHANICAL FORCES

Cytoskeletal, adhesion, and motor proteins inside and between cells generate physical forces that in turn control cell behavior. These forces result in large-scale strain fields, which enable cell sheets to move and deform as a coherent unit, and thus execute the folds and bends that shape complex organs.

The software of life, which exploits the laws of physics and computation, is enabled by chemical, mechanical, and electrical signaling across cellular networks. While the chemical and mechanical mechanisms of morphogenesis have long been appreciated by molecular and cell biologists, the role of electrical signaling has largely been overlooked. But the same reprogrammability of neural circuits in the brain that supports learning, memory, and behavioral plasticity applies to all cells, not just neurons. Indeed, bacterial colonies can communicate via ionic currents, with recent research revealing brain-like dynamics in which information is propagated across and stored in a kind of proto-body formed by bacterial biofilms. So it should really come as no surprise that bioelectric signaling is a highly tractable component of morphological outcomes in multicellular organisms.

A few years ago, we studied the electrical dynamics that normally set the size and borders of the nascent Xenopus brain, and built a computer model of this process to shed light on how a range of various brain defects arise from disruptions to this bioelectric signaling. Our model suggested that specific modifications with mRNA or small molecules could restore the endogenous bioelectric patterns back to their correct layout. By using our computational platform to select drugs to open existing ion channels in nascent neural tissue or even a remote body tissue, we were able to prevent and even reverse brain defects caused not only by chemical teratogenscompounds that disrupt embryonic developmentbut by mutations in key neurogenesis genes.

Similarly, we used optogenetics to stimulate electrical activity in various somatic cell types totrigger regeneration of an entire tadpole tailan appendage with spinal cord, muscle, and peripheral innervationand to normalize the behavior of cancer cells in tadpoles strongly expressing human oncogenes such as KRAS mutations. We used a similar approach to trigger posterior regions, such as the gut, to build an entire frog eye. In both the eye and tail cases, the information on how exactly to build these complex structures, and where all the cells should go, did not have to be specified by the experimenter; rather, they arose from the cells themselves. Such findings reveal how ion channel mutations result in numerous human developmental channelopathies, and provide a roadmap for how they may be treated by altering the bioelectric map that tells cells what to build.

We also recently found a striking example of such reprogrammable bioelectrical software in control of regeneration in planaria. In 2011, we discovered that an endogenous electric circuit establishes a pattern of depolarization and hyperpolarization in planarian fragments that regulate the orientation of the anterior-posterior axis to be rebuilt. Last year, we discovered that this circuit controls the gene expressionneeded to build a head or tail within six hours of amputation, and by using molecules that make cell membranes permeable to certain ions to depolarize or hyperpolarize cells, we induced fragments of such worms to give rise to a symmetrical two-headed form, despite their wildtype genomes. Even more shockingly, the worms continued to generate two-headed progeny in additional rounds of cutting with no further manipulation. In further experiments, we demonstrated that briefly reducing gap junction-mediated connectivity between adjacent cells in the bioelectric network that guides regeneration led worms to regenerate head and brain shapes appropriate to other worm species whose lineages split more than 100 million years ago.

My group has developed the use of voltage-sensitive dyes to visualize the bioelectric pattern memory that guides gene expression and cell behavior toward morphogenetic outcomes. Meanwhile, my Allen Center colleagues are using synthetic artificial electric tissues made of human cells and computer models of ion channel activity to understand how electrical dynamics across groups of non-neural cells can set up the voltage patterns that control downstream gene expression, distribution of morphogen molecules, and cell behaviors to orchestrate morphogenesis.

The emerging picture in this field is that anatomical software is highly modulara key property that computer scientists exploit as subroutines and that most likely contributes in large part to biological evolvability and evolutionary plasticity. A simple bioelectric state, whether produced endogenously during development or induced by an experimenter, triggers very complex redistributions of morphogens and gene expression cascades that are needed to build various anatomies. The information stored in the bodys bioelectric circuitscan be permanently rewritten once we understand the dynamics of the biophysical circuits that make the critical morphological decisions. This permanent editing of the encoded target morphology without genomic editing reveals a new kind of epigenetics, information that is stored in a medium other than DNA sequences and chromatin.

Recent work from our group and others has demonstrated that anatomical pattern memories can be rewritten by physiological stimuli and maintained indefinitely without genomic editing. For example, the bioelectric circuit that normally determines head number and location in regenerating planaria can be triggered by brief alterations of ion channel or gap junction activity to alter the animals body plan. Due to the circuits pattern memory, the animals remain in this altered state indefinitely without further stimulation, despite their wildtype genomes. In other words, the pattern to which the cells build after damage can be changed, leading to a target morphology distinct from the genetic default.

N.R. FULLER, SAYO-ART, LLC

First, we soaked a planarian in voltage-sensitive fluorescent dye to observe the bioelectrical pattern across the entire tissue. We then cut the animal to see how this pattern changes in each fragment as it begins to regenerate.

We then applied drugs or used RNA interference to target ion channels or gap junctions in individual cells and thus change the pattern of depolarization/hyperpolarization and cellular connectivity across the whole fragment.

As a result of the disruption of the bodys bioelectric circuits, the planarian regrows with two heads instead of one, or none at all.

When we re-cut the two-headed planarian in plain water, long after the initial drug has left the tissue, the new anatomy persists in subsequent rounds of regeneration.

Cells can clearly build structures that are different from their genomic-default anatomical outcomes. But are cells universal constructors? Could they make anything if only we knew how to motivate them to do it?

The most recent advances in the new field at the intersection of developmental biology and computer science are driven by synthetic living machines known as biobots. Built from multiple interacting cell populations, these engineered machines have applications in disease modeling and drug development, and as sensors that detect and respond to biological signals. We recently tested the plasticity of cells by evolving in silico designs with specific movement and behavior capabilities and used this information to sculpt self-organized growth of aggregated Xenopus skin and muscle cells. In a novel environmentin vitro, as opposed to inside a frog embryoswarms of genetically normal cells were able to reimagine their multicellular form. With minimal sculpting post self-assembly, these cells form Xenobots with structures, movements, and other behaviors quite different from what might be expected if one simply sequenced their genome and identified them as wildtype X. laevis.

These living creations are a powerful platform to assess and model the computations that these cell swarms use to determine what to build. Such insights will help us to understand evolvability of body forms, robustness, and the true relationship between genomes and anatomy, greatly potentiating the impact of genome editing tools and making genomics more predictive for large-scale phenotypes. Moreover, testing regimes of biochemical, biomechanical, and bioelectrical stimuli in these biobots will enable the discovery of optimal stimuli for use in regenerative therapies and bioengineered organ construction. Finally, learning to program highly competent individual builders (cells) toward group-level, goal-driven behaviors (complex anatomies) will significantly advance swarm robotics and help avoid catastrophes of unintended consequences during the inevitable deployment of large numbers of artificial agents with complex behaviors.

Understanding how cells and tissues make real-time anatomical decisions is central to achieving regenerative outcomes too complex for us to manage directly.

The emerging field ofsynthetic morphology emphasizes a conceptual point that has been embraced by computer scientists but thus far resisted by biologists: the hardware-software distinction. In the 1940s, to change a computers behavior, the operator had to literally move wires aroundin other words, she had to directly alter the hardware. The information technology revolution resulted from the realization that certain kinds of hardware are reprogrammable: drastic changes in function could be made at the software level, by changing inputs, not the hardware itself.

In molecular biomedicine, we are still focused largely on manipulating the cellular hardwarethe proteins that each cell can exploit. But evolution has ensured that cellular collectives use this versatile machinery to process information flexibly and implement a wide range of large-scale body shape outcomes. This is biologys software: the memory, plasticity, and reprogrammability of morphogenetic control networks.

The coming decades will be an extremely exciting time for multidisciplinary efforts in developmental physiology, robotics, and basal cognition to understand how individual cells merge together into a collective with global goals not belonging to any individual cell. This will drive the creation of new artificial intelligence platforms based not on copying brain architectures, but on the multiscale problem-solving capacities of cells and tissues. Conversely, the insights of cognitive neurobiology and computer science will give us a completely new window on the information processing and decision-making dynamics in cellular collectives that can very effectively be targeted for transformative regenerative therapies of complex organs.

Michael Levinis the director of the Allen Discovery Center at Tufts University and Associate Faculty at Harvard Universitys Wyss Institute. Email him atmichael.levin@tufts.edu. M.L. thanks Allen Center Deputy DirectorJoshua Finkelsteinfor suggestions on the drafts of this story.

Originally posted here:
How Groups of Cells Cooperate to Build Organs and Organisms - The Scientist

Read More...

Viral Vector Manufacturing Market Forecast to Reach $1.47 Billion by 2025 – ResearchAndMarkets.com – Business Wire

Wednesday, September 2nd, 2020

DUBLIN--(BUSINESS WIRE)--The "Viral Vector Manufacturing Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

The global viral vector manufacturing market is projected to grow at a CAGR of 22.09% to reach a market size of US$1,469.144 million in 2025 from US$443.592 million in 2019.

The viral vector market is primarily being driven by the growing adoption of adenoviral vectors, lentiviral vectors, as well as retroviral vectors. The growing adoption stems from the need for effectively transferring therapeutic gene into the target cells that are an integral part of the process that involves the insertion of a functional copy of a gene into a defective cell one of the preferred treatment options for most chronic diseases, which is known as Gene therapy.

Furthermore, the growing number of clinical trials, the increasing number of gene therapy, and the expanding cognizance of effective mode of disease treatment are further expected to drive the growth of the viral vector manufacturing market during the forecast period. Since vector designing, production, packaging, and release testing is subject to limited availability and faced with challenges due to the complex nature of technologies and platform and thus many players in this space often endeavor in striking strategic collaboration and acquisitions that cover many aspects like the delivery of clinical grade product under its ambit, to facilitate the successful collaboration development of viral agent-based products.

Moreover, the efficient ability to express the therapeutic genes and non-pathogenic nature is another factor that is responsible for driving the growth of this market. The other key factors that are expected to drive the growth of the market are the increasing investment in the biopharmaceutical production coupled with the growing aging population, healthcare expenditure, technological advancement, especially in the genetic engineering segment.

Moreover, the increasing accessibility of healthcare facilities, the growing demand for treatment of disease due to the increasing global burden of diseases are a few of the other factors that are poised to drive the growth of this market during the forecast period. Nevertheless, despite the transitioning of this niche industry to high manufacturing is one such factor that may restrain the growth of the market to a certain extent.

Therefore, with such growing recognition of the importance of viral vectors, various developments are taking place in the viral vector manufacturing market. For instance, in June 2020, it was announced by Emergent BioSolutions Inc. (NYSE: EBS) which is a global life sciences company that it is going to invest $75 Million in Canton Site and expand viral vector and gene therapy capability facilitating the reinforcement of its contract development and manufacturing (CDMO) capabilities.

Again, in June 2020, Oxford Biomedica (LSE: OXB) which is a major gene and cell therapy group, announced that it has signed an agreement of collaboration with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization that has been established to provide the first strategic vaccine development and progressive manufacturing capability in the UK. Under this 5-year agreement, the organization will work towards enabling the manufacture of vaccines that are based on viral vector, to contribute towards a swift growth in the domestic capacity for this specialized field of vaccine manufacturing.

In April 2020, Merck KGaA (FWB: MRK) a leading science and technology company announced that a 100 million facility, second in Carlsbad, California USA that is intended to boost its BioReliance viral and gene therapy service offering to help their customers to aid their customers to commercialize the gene therapies that are brought about by viral vectors concomitantly helping innovators scale up their production that is in tandem with the quantum that allows them to reach out to more patients.

Earlier, in January 2020, the launch of ZYNTEGLO (autologous CD34+ cells encoding A-T87Q-globin gene) in Germany was announced by bluebird bio, Inc. (Nasdaq: BLUE). ZYNTEGLO is a one-time gene therapy that has been specifically developed for patients aged 12 years and older with transfusion-dependent -thalassemia (TDT) who do not possess 0/0 genotype.

In December 2019, it was announced that a leading supplier of services and technologies for the life sciences industry called Novasep launched oXYgene which is a fully integrated offering for the construction of facilities dedicated towards customers to aid them in their viral vector production.

In October 2019, it was reported that GE Healthcare Life Sciences which has now rebranded itself as Cytiva, was about to launch the KUBio box which is an adaptable, flexible and fully integrated environment for biomanufacturing to accelerate the production gene therapies based on of viral vector. These latest additions were intended to bring gene therapies swiftly to the market thereby contributing to the increased capacity in the viral vector area.

In March 2018, it was reported that Sartorius Stedim Biotech SA (SSB), which is a major international technology partner supplier of products and services biopharmaceutical industry has been selected by ABL Europe as its chief supplier of single-use systems whereby the new viral vector manufacturing capacity has been started in Strasbourg at its European facility. ABL Europe, a subsidiary of ABL Inc. provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.

Key Topics Covered

1. Introduction

1.1. Market Definition

1.2. Market Segmentation

2. Research Methodology

2.1. Research Data

2.2. Assumptions

3. Executive Summary

3.1. Research Highlights

4. Market Dynamics

4.1. Market Drivers

4.2. Market Restraints

4.3. Porters Five Forces Analysis

4.4. Industry Value Chain Analysis

5. Viral Vector Manufacturing Market Analysis, By Type

5.1. Introduction

5.2. Retroviral vectors

5.3. Lentiviral Vectors

5.4. Adenoviral Vectors

5.5. Others

6. Viral Vector Manufacturing Market Analysis, By Application

6.1. Introduction

6.2. Vaccinology

6.3. Gene Therapy

7. Viral Vector Manufacturing Market Analysis, By End-User

7.1. Introduction

7.2. Pharmaceutical & Biotechnology Companies

7.3. Research Institutes

7.4. Contract Research Organizations

8. Viral Vector Manufacturing Market Analysis, by Geography

8.1. Introduction

8.2. North America

8.3. South America

8.4. Europe

8.5. The Middle East & Africa

8.6. Asia-Pacific

9. Competitive Environment and Analysis

9.1. Major Players and Strategy Analysis

9.2. Emerging Players and Market Lucrativeness

9.3. Mergers, Acquisitions, Agreements, and Collaborations

9.4. Vendor Competitiveness Matrix

10. Company Profiles

10.1. Sirion-Biotech GmbH

10.2. Vigene Biosciences

10.3. Batavia Biosciences B.V.

10.4. Virovek

10.5. Lonza

10.6. Vector Biolabs

10.7. Cobra Biologics

10.8. MaxCyte, Inc.

10.9. Genelux

10.10. BioNTech SE

For more information about this report visit https://www.researchandmarkets.com/r/c3nfai

View original post here:
Viral Vector Manufacturing Market Forecast to Reach $1.47 Billion by 2025 - ResearchAndMarkets.com - Business Wire

Read More...

CAR T-Cell Optimization Starts in Production, Extends to Therapy – Genetic Engineering & Biotechnology News

Wednesday, September 2nd, 2020

Just as heat-seeking missiles race toward the infrared signatures of their targets, chimeric antigen receptor (CAR) T cells home in on cancer-associated or -specific antigens. Once the antigens are engaged, CAR T cells let fly with cytotoxic flak, granules containing perforin and granzymes, while activating supplementary tumor-killing mechanisms such as stromal sensitization and macrophage polarization. It is to be hoped that by the time the cytotoxic smoke clears, the cancer will have been destroyed.

The development of CAR T cells has revolutionized adoptive cellular therapies against cancer. CARs are genetically engineered to combine antigen- or tumor-specific-binding with T-cell activating domains. T cells, obtained from the patient (autologous cells) or from a healthy donor (allogeneic cells), are typically transduced with an engineered vector, expanded, and infused back into the patient for tumor eradication.

In the 10 years since its inception, the CAR T-cell field has progressed rapidly. Two CAR T-cell products have been approved for clinical use, and many more products are undergoing clinical trials or are in development. Although the field initially focused on B-cell malignancies, it is now advancing on solid tumors.

Despite its initial success, the CAR T-cell field must find ways to generate products that are potent, affordable, and available. To achieve enduring success, the CAR T-cell field is undertaking a range of initiatives. These include the engineering of bridging proteins for multiantigen targeting; the creation of nonviral allogeneic off-the-shelf products; the organization of vein-to-vein networks; and the development of precisely tuned therapies, that is, precisely timed and dosed therapies.

Cellular therapy is a living drug, declares Steve Shamah, PhD, senior vice president, Obsidian Therapeutics. As with any drug, damage can occur if the therapy is not carefully regulated. Our company focuses on creating controllable cell therapies by engineering CAR T cells or tumor-infiltrating lymphocytes to produce regulatable cytokines and proteins that can enhance functional activity, especially against solid tumors.

For example, the company is developing a platform that armors CAR T cells with immunomodulatory factors such as interleukin-15 (IL-15) or CD40 ligand. Shamah explains, These factors can enhance functional activity by driving T-cell expansion, conferring resistance to immunosuppression, improving antigen presentation, and inducing antigen spread. However, both factors can also produce systemic toxicity. Our technology modulates the level and timing of their activity in a fully controlled, dose-dependent manner using an FDA-approved small-molecule drug.

The Obsidian platform, cytoDRiVE, adds a drug-responsive domain (DRD) onto a therapeutic protein of interest. DRD tags are misfolded or inherently unstable in the cell. However, they can be reversibly stabilized by the binding of approved small-molecule drugs. When the drug is absent, the DRD-tagged protein is turned off. When the drug is present, the DRD-tagged protein is turned on. When DRD tags are in place, the concentration of the small-molecule drug serves as a biological rheostat for controlling the dosing of the therapeutic protein.

Preclinical in vivo mouse studies assessed anti-CD19 CAR T cells that were engineered to express an IL-15-DRD that responded to the FDA-approved drug acetazolamide. In these studies, tumor regression was demonstrated.

Controlling the precise timing and expression level of these immunomodulatory factors in CAR T cells could significantly enhance safety and therapeutic efficacy, concludes Shamah.

Obsidian is currently focusing on the oncology space, but the company is also exploring other areas such as autoimmunity and even the regulation of transcription factors to enable controllable in vivoCRISPR-Cas9 gene editing.

Despite the remarkable success of CAR T-cell therapies, relapses can occur within six months for up to 50% of patients treated with anti-CD19 CAR T-cell therapy.Failures can occur due to loss of CD19 expression or to continued tumor proliferation. Aleta Biotherapeutics has developed a novel technology to reactivate CAR T cells in relapsed patients.

Our approach utilizes antigen-bridging proteins to coat tumors with CD19, says Paul Rennert, PhD, Aletas president and CSO. [The tumors are then] recognized by the patients anti-CD19 CAR T cells, essentially creating a cytotoxic synapse that results in tumor cell death.

To thwart anti-CD19 CAR T-cell therapy relapses, the company developed a bridging protein using the extracellular domain of CD19 and an anti-CD20 antibody domain. CD20 is an antigen present on the majority of B-cell malignancies. Rennert explains that these injected bridging proteins will coat the patients tumor cells with CD19, creating a target to activate or reactivate a patients anti-CD19 CAR T cells.

To show proof-of-principle, the company performed in vivo studies using a half-life-extended form of the bridging protein injected into mice carrying CD20-positive tumor cells and anti-CD19 CAR T cells. Rennert emphasizes, Our studies demonstrated this strategy can be used to reactivate CD19 CAR T cells to prevent and reverse relapses.

Other programs in development include a bridging protein for injection to improve outcomes in multiple myeloma patients treated with CAR T cells, and bridging protein programs for HER2-positive breast cancer patients with central nervous system metastases. The company is preparing investigational new drug applications for its technology and plans to start Phase I trials in 2021.

Assessing whether engineered CAR T-cell and T-cell receptor (TCR) therapies have successfully attacked and penetrated solid tumors (and not normal cells) can be like finding the proverbial needle in the haystack. Traditional methods using immunohistochemistry are useful for immune profiling, but they cannot differentiate engineered versus endogenous cells, points out Christopher Bunker, PhD, senior director of business development, Advanced Cell Diagnostics, a Bio-Techne brand. We developed a means to easily detect and track engineered therapeutic cells and delineate their pharmacokinetics within the tumor microenvironment of intact tumor biopsies, as well as their on-target/off-tumor activity.

Enter RNAscope, an RNA in situ hybridization technology that can enable single-cell spatial transcriptomics. RNAscope, Bunker asserts, is the only off-the-shelf method that can specifically detect engineered CAR T cells and TCR T cells in solid tumor patient biopsies.

Most cell therapies employ lentivirus transduction. Because CAR or TCR transgenes have unique sequences in the viral untranslated regions, these can be used as tags for identification of engineered cell therapies with RNAscope probes. The technology utilizes pools of paired oligos that can be thought of as a ZZ pair, where the paired 3 ends hybridize to ~50 bases of target mRNA, and where the paired 5 ends hybridize to a signal amplification module, which is built through sequential hybridization steps. The signal amplification of paired oligos results in an assay able to detect individual transcripts that appear as visible and quantifiable dots.

Its a little like planting and lighting Christmas trees, quips Bunker. The ZZ pairs plant trees along the mRNA with branches that are decorated either with fluorophores or chromogens. Although the primary technology currently features four colors, the company has developed a HiPlex (12-plex) assay and foresees even higher-plex assays with different detection methods.

We envision assays based on our core technologies that enable spatial analysis of perhaps a hundred transcripts in combination with tens of proteins, Bunker projects. In the context of cell therapy development, these will enable a more comprehensive understanding of tumor biology and immune cell profiles to determine the most effective treatment strategy for a patient, as well as for monitoring efficacy of solid tumor cellular therapies.

Companies developing CAR T-cell products are also eyeing a future involving GMP production. Thus, a critical early question is how to choose the best T-cell medium for manufacturing processes. To test the suitability of a CAR T-cell growing medium, companies must assess factors such as cell viability, cell expansion, cytokine profiles, and cell purity. A medium suitable for a CAR T-cell manufacturing process also needs to support rapid activation and CAR transduction. Additionally, the selected medium needs to be compatible with a variety of donors.

There are many available choices for T-cell culture media ranging from do-it-yourself recipes to commercially available one-size-fits-all complete formulations. CellGenix has developed a novel T-cell medium that avoids the use of human serum. Sebastian Warth, PhD, a senior scientist at CellGenix, explains, To achieve consistent results, human serum requires extensive testing prior to its use for production of cellular products due to lot-to-lot inconsistencies. Since human serum is a limited resource and might not be available in large quantities, it is unfavorable for commercial-scale manufacturing. Furthermore, the human origin of serum poses a certain risk of containing adventitious agents and is, therefore, a risk to the safety of the T-cell therapy product.

The companys TCM GMP-Prototype medium provides a serum-free and xeno-free product for early-onset T-cell expansion. According to Warth, key advantages include promotion of sustained viability, support for expansion of CD4+ and CD8+ T cells, promotion of a central memory and early differentiated memory T-cell phenotype, and maintenance of a high proportion of cytokine-producing cells including polyfunctional cells. Further, it was optimized for and verified with CAR T cells.

While autologous CAR T-cell therapies have proven highly successful, they also require a long and expensive manufacturing process. The dream of being able to utilize off-the-shelf allogeneic T cells is on the horizon.

Devon J. Shedlock, PhD, senior vice president, research and development,Poseida Therapeutics, reports, With our technology, we are able to genetically modify cells to create a fully allogenic, or off-the-shelf, product that does not require additional immunosuppression treatment like earlier generation approaches. We also have developed technology to allow us to make hundreds of doses from a single manufacturing run from healthy donors, thereby dropping the cost substantially.

According to Shedlock, the technology consists of three key aspects: 1) the piggyback DNA Modification System, 2) the Cas-CLOVER site-specific gene editing system, and 3) the Booster Molecule.

The PiggyBac DNA Modification System is a nonviral technology for stably integrating genes into DNA. One key feature is that piggyBac preferentially inserts into less mature T cells, enabling the production of therapies that have a high proportion of stem cell memory T cells, or Tscm cells.

Viral technologies are virtually excluded from Tscm cells, Shedlock states. However, Tscm cells are the ideal cell type for cell-based therapies because they have the ability to engraft and potentially last a lifetime, can produce wave after wave of more differentiated cells to attack the tumor, and are much more tolerable with low levels of adverse events compared to other CAR T-cell products.

The companys Cas-CLOVER gene editing technology is a hybrid gene editing technology used to edit the T cells to make allogeneic products. Cas-CLOVER works well in resting T cells, which is important in preserving Tscm cells in a fully allogeneic CAR T-cell product, Shedlock elaborates. It also is a very precise and clean system. This is a particularly important safety issue for allogeneic products that may be given to many patients.

The Booster Molecule is added during manufacture and is temporarily expressed on the cell surface to allow cell stimulation. Normally when allogeneic CAR T-cell products are created, the T-cell receptor must be eliminated to avoid the graft-versus-host reaction, which is a major safety issue. Importantly, this booster stimulation occurs while preserving the Tscm phenotype.

Poseida Therapeutics expects to launch a clinical trial for its multiple myeloma allogeneic product late this year or early next year. The company will also begin clinical trials later in 2021 on its pan-solid tumor allogeneic program.

Creation of partnerships can help drive development of CAR T-cell therapeutics from concept through clinical trials. Advanced therapies require advanced supply chain and data management, advises Minh Hong, PhD, head of autologous cell therapy, Lonza Pharma & Biotech. Prior biopharmaceutical models of mass production and distributionand the systems that support themare not effective for personalized therapeutics. As manufacturing demand increases for autologous cell therapies, there is an overarching need to both industrialize and simplify the entire supply chain ecosystem.

Hong says the overall project needs to be considered from a more comprehensive perspective: Due to the criticality of the starting material, everything from cell sourcing, patient coordination and scheduling for collection/infusion, transportation logistics, and manufacturing logistics needs to be coordinated, ensuring the highest standards, regulatory compliance, and safety throughout the process.

To meet these needs, Lonza is building a network of partners to develop a fully integrated vein-to-vein solution, that is, a system that includes all touch points involved in patient scheduling and sample collection, through material shipping logistics, manufacturing, and eventually the infusion of the cell therapy back into the patient. The partner network, Hong indicates, will help participants define smart workflows and execute an integration strategy. Hong sums up the networks therapeutic implications as follows: We believe these partnerships will decrease time to clinical program setup.

Lonza has more than a 20-year history of providing clinical and commercial manufacturing. Hong asserts, Our company brings to the table our process development and manufacturing experience along with proprietary solutions including a manufacturing execution system solution, MODA-ESTM, for electronic batch records and manufacturing traceability. In addition, we have announced partnerships with Vineti for a supply chain orchestration system and Cryoport to aid in shipping and logistics.

Lonza is also looking beyond CAR T-cell therapies. We would not limit our solutions and partnerships to autologous cell therapies, Hong declares. We can envision solutions for our in vivo viral vector manufacturing clients as well as our traditional allogeneic cell therapy clients.

View post:
CAR T-Cell Optimization Starts in Production, Extends to Therapy - Genetic Engineering & Biotechnology News

Read More...

Genetic Engineering Market 2020 Share Growing Rapidly with Recent Trends, Revenue, Top Players and Forecast to 2027 – Scientect

Wednesday, September 2nd, 2020

Fort Collins, Colorado Reports Globe recently added the Genetic Engineering Market research report which has an in-depth scenario analysis of the market size, share, demand, growth, trends, and the forecast from 2020-2027. The report deals with the impact analysis of the COVID-19 pandemic. The COVID-19 pandemic has affected export-import, demand and industry trends and is expected to have economic effects on the market. The report provides a comprehensive analysis of the impact of the pandemic across the industry and an overview of a post-COVID-19 market scenario.

The report mainly mentions definitions, classifications, applications, and market reviews of the Genetic Engineering industry. It also includes product portfolios, manufacturing processes, cost analyzes, structures and the gross margin of the industry. It also offers a comprehensive analysis of key competitors, their regional breakdown and market size.

Global Genetic Engineering Market to reach USD XX billion by 2025.Global Genetic Engineering Market valued approximately USD XX billion in 2017 is anticipated to grow with a healthy growth rate of more than XX% over the forecast period 2019-2026.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The report provides a comprehensive analysis in an organized manner in the form of tables, graphs, charts, figures, and diagrams. The organized data paves the way for thorough examination and research of the current and future outlook of the market.

The examination of the Genetic Engineering industry provides an in-depth analysis of the key market drivers, opportunities, challenges, and their impact on the working of the market. The technological advancements and product developments, driving the demands of the market are also covered in the report.

The report provides comprehensive data on the Genetic Engineering market and its trends to assist the reader in formulating decisions to accelerate the business. The report provides a complete overview of the economic scenario of the market, along with benefits and limitations.

Genetic Engineering market report contains industrial chain analysis and value chain analysis to provide a comprehensive view of the Genetic Engineering market. The study is composed of market analysis along with a detailed analysis of the application segments, product types, market size, growth rate, and current and emerging trends in the industry.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

By Devices:

By Techniques:

By End-User:

By Application:

Geographically, the market is spread across several key geographical regions, and the report covers the regional analysis as well as the production, consumption, revenue, and market share in those regions for the forecast period of 2020-2027. The regions includeNorth America, Latin America, Europe, Asia-Pacific, and the Middle East and Africa.

Radical Coverage of the Genetic Engineering Market:

Thank you for reading our report. For further queries on the report and customization, please connect with us. Our team will ensure you get the report best suited for your needs.

How Reports Globe is different than other Market Research Providers

The inception of Reports Globe has been backed by providing clients with a holistic view of market conditions and future possibilities/opportunities to reap maximum profits out of their businesses and assist in decision making. Our team of in-house analysts and consultants works tirelessly to understand your needs and suggest the best possible solutions to fulfill your research requirements.

Our team at Reports Globe follows a rigorous process of data validation, which allows us to publish reports from publishers with minimum or no deviations. Reports Globe collects, segregates, and publishes more than 500 reports annually that cater to products and services across numerous domains.

Contact us:

Mr. Mark Willams

Account Manager

US: +1-970-672-0390

Email:[emailprotected]

Web:reportsglobe.com

View original post here:
Genetic Engineering Market 2020 Share Growing Rapidly with Recent Trends, Revenue, Top Players and Forecast to 2027 - Scientect

Read More...

From Cotton to Brinjal: Fraudulent GMO Project in India Sustained by Deception – CounterPunch

Wednesday, September 2nd, 2020

Insecticidal Bt (Bacillus thuringiensis) cotton is the first and only GM (genetically modified) crop that has been approved in India. It has been cultivated in the country for more than 20 years. In a formal statement to the Supreme Court of India, the Indian government has asserted that hybrid Bt cotton is an outstanding success. It therefore argues that Bt cotton is a templatefor the introduction of GM food crops.

However, over the last week, two important webinars took place that challenged the governments stance. The first was on Bt cotton and involved a panel of internationally renowned scientists who conclusively debunked the myth of Bt cotton success in India. The webinar, organised by the Centre for Sustainable Agriculture and Jatan, focused on an evidence-based evaluation of 18 years of approved Bt cotton cultivation in India.

The second webinar discussed the case of Bt brinjal, which the countrys apex regulatory body, the Genetic Engineering Appraisal Committee (GEAC), has brought to the brink of commercialisation. The webinar highlighted deep-seated problems with regulatory processes in India and outlined how the GEAC is dogged by secrecy, conflicts of interest and (scientific) fraud: participants outlined how the GEAC has been colluding with crop developers and seed companies to drive GM crops into agriculture.

Bt cotton failure

The panel for the Bt cotton webinar (YouTube: Bt Cotton in India: Myths & Realities An Evidence-Based Evaluation) on 24 August included Dr Andrew Paul Gutierrez, senior emeritus professor in the College of Natural Resources at the University of California at Berkeley; Dr Keshav Kranthi, former director of Central Institute for Cotton Research in India; Dr Peter Kenmore, former FAO representative in India, and Dr Hans Herren, World Food Prize Laureate.

Dr Herren said that the failure of Bt cotton is a classic representation of what an unsound science of plant protection and faulty direction of agricultural development can lead to.

He explained:

Bt hybrid technology in India represents an error-driven policy that has led to the denial and non-implementation of the real solutions for the revival of cotton in India, which lie in HDSS (high density short season) planting of non-Bt/GMO cotton in pure line varieties of native desi species and American cotton species.

He argued that a transformation of agriculture and the food system is required; one that entails a shift to agroecology, which includes regenerative, organic, biodynamic, permaculture and natural farming practices.

Dr Kenmore said that Bt cotton is an aging pest control technology:

It follows the same path worn down by generations of insecticide molecules from arsenic to DDT to BHC to endosulfan to monocrotophos to carbaryl to imidacloprid. In-house research aims for each molecule to be packaged biochemically, legally and commercially before it is released and promoted. Corporate and public policy actors then claim yield increases but deliver no more than temporary pest suppression, secondary pest release and pest resistance.

Recurrent cycles of crises have sparked public action and ecological field research which creates locally adapted agroecological strategies.

He added that this agroecology:

now gathers global support from citizens groups, governments and UN-FAO. Their robust local solutions in Indian cotton do not require any new molecules, including endo-toxins like in Bt cotton.

Prof Gutierrez presented the ecological reasons as to why hybrid Bt cotton failed in India: long season Bt cotton introduced in India was incorporated into hybrids that trapped farmers into biotech and insecticide treadmills that benefited GMO seed manufacturers.

He noted:

The cultivation of long-season hybrid Bt cotton in rainfed areas is unique to India. It is a value capture mechanism that does not contribute to yield, is a major contributor to low yield stagnation and contributes to increasing production costs.

Prof Gutierrez asserted that increases in cotton farmer suicides are related to the resulting economic distress.

He argued:

A viable solution to the current GM hybrid system is adoption of improved non-GM high-density short-season fertile cotton varieties.

Presenting data on yields, insecticide usage, irrigation, fertiliser usage and pest incidence and resistance, Dr Keshav Kranthi said that a critical analysis of official statistics (eands.dacnet.nic.inandcotcorp.gov.in) shows that Bt hybrid technology has not been providing any tangible benefits in India either in yield or insecticide usage.

He said that cotton yields are the lowest in the world in Maharashtra, despite being saturated with Bt hybrids and the highest use of fertilisers. Yields in Maharashtra are less than in rainfed Africa where there is hardly any usage of technologies such as Bt, hybrids, fertilisers, pesticides or irrigation.

It is revealing that Indian cotton yields rank 36th in the world and have been stagnant in the past 15 years and insecticide usage has been constantly increasing after 2005, despite an increase in area under Bt cotton.

Dr Kranthi argued that research also shows that the Bt hybrid technology has failed the test of sustainability with resistance in pink bollworm to Bt cotton, increasing sucking pest infestation, increasing trends in insecticide and fertiliser usage, increasing costs and negative net returns in 2014 and 2015.

Dr Herren said that GMOs exemplify the case of a technology searching for an application:

It is essentially about treating symptoms, rather than taking a systems approach to create resilient, productive and bio-diverse food systems in the widest sense and to provide sustainable and affordable solutions in its social, environmental and economic dimensions.

He went on to argue that the failure of Bt cotton is a classic representation of what an unsound science of plant protection and a faulty direction of agricultural development can lead to:

We need to push aside the vested interests blocking the transformation with the baseless arguments of the world needs more food and design and implement policies that are forward looking We have all the needed scientific and practical evidence that the agroecological approaches to food and nutrition security work successfully.

Bt brinjal the danger is back

The governments attempt to use a failed technology as a template for driving GMOs into agriculture has been exposed. Nevertheless, the GEAC has been moving forward with late-stage trials of Bt brinjal, while ignoring the issues and arguments against its commercialisation that were forwarded a decade ago.

In February 2010, the Indian government placed an indefinite moratorium on the release of Bt brinjal after numerous independent scientific experts from India and abroad had pointed out safety concerns based on data and reports in the biosafety dossier that Mahyco, the crop developer, had submitted to the regulators.

The then Minister of the Ministry of Environment and Forests Jairam Ramesh had instituted a unique four-month scientific enquiry and public hearings. His decision to reject the commercialisation of Bt brinjal was supported by advice from the renowned scientists.Their collective appraisals demonstrated serious environmental and biosafety concerns.

Jairam Ramesh pronounced a moratorium on Bt brinjal in February 2010 by stating:

it is my duty to adopt a cautious, precautionary principle-based approach and impose a moratorium on the release of Bt brinjal, till such time independent scientific studies establish, to the satisfaction of both the public and professionals, the safety of the product from the point of view of its long-term impact on human health and environment, including the rich genetic wealth existing in brinjal in our country.

The moratorium has not been lifted and the conditions he set out have still not been met. Moreover, five high-level reportshave advised against the adoption of GM crops in India. Appointed by the Supreme Court, the Technical Expert Committee (TEC) Final Report (2013) was scathing about the prevailing regulatory system and highlighted its inadequacies. The TEC went a step further by recommending a 10-year moratorium on the commercial release of all GM crops.

The regulatory process was shown to lack competency, possessed endemic conflicts of interest and demonstrated a lack of expertise in GMO risk assessment protocols, including food safety assessment and the assessment of environmental impacts.

Ten years on and regulators have done nothing to address this woeful state of affairs. As we have seen with the relentless push to get GM mustard commercialised, the problems persist. Through numerous submissions to the Supreme Court, Aruna Rodrigues has described how GM mustard is being forced through withflawed tests (or no tests) and a lack of public scrutiny.Regulators are seriously conflicted: they promote GMOs openly, fund them and then regulate them.

And this is precisely what the webinar Bt brinjal the danger is back (watch onYouTube) discussed on 27 August. Organised by the Coalition for a GM-Free India, the webinar was arranged because the regulators have again brought to the brink of commercialisation a new Bt brinjal event a different Bt brinjal than the 2010 version. Also included in the webinar were the experiences of Bt brinjal introduction in Bangladesh.

Dr Ramanjaneyulu (Centre for Sustainable Agriculture) highlighted how need has never been established for Bt brinjal of which India is a recognised centre of diversity. The argument for Bt brinjal in the run-up to Jairam Rameshs moratorium was that pesticide use is a problem in containing the brinjal fruit and shoot borer. He noted that Bt brinjal was promoted by Monsanto, USAID and Cornell University, but serious protocol violations, environmental contamination concerns and potential adverse health impacts were discovered.

He outlined simple non-pesticidal, agroecological management practises that can and are being used to deal with the brinjal fruit and shoot borer.

Farida Akhter of UBINIG (Policy Research for Development Alternative) outlined how the introduction of Bt brinjal in Bangladesh was not needed but imposed on the country, which has 248 varieties of brinjal. Where pesticide use is problematic, she argued that it concerns hybrid varieties rather than traditional cultivars of which 24 varieties are resistant to fruit and shoot borer.

Akhter said that poor quality brinjal and financial losses for farmers have been major issues. Many have abandoned Bt brinjal, but farmers have received incentives to cultivate and where they have done so, fertiliser use has increased and there have been many pest attacks, with 35 different types of pesticides applied.

The Bill Gates-funded Cornell Alliance for Science, a public relations entity that promotes GM agriculture, and USAID, which serves the interests of the GMO biotech sector, tried to sell Bt brinjal on the basis it would save people from the overuse of pesticides and related illnesses. But Akhter argued that Bangladesh was targeted because the Philippines and India had rejected Bt brinjal. Again, protocol violations occurred leading to its introduction and Akhter concluded that there was no scientific basis for Bt brinjal: its introduction was political.

As for India, event EE1, the initial Bt brinjal, has now been replaced by event 142, a different Bt brinjal. Kavitha Kuruganti (Alliance for Sustainable and Holistic Agriculture) explained this in the webinar and notes that the GEAC, immediately after the 2010 moratorium was announced, went straight ahead and sanctioned new trials for this Bt brinjal. The GEAC basically stated that the moratorium did not apply to this version, while ignoring all the criticisms about lack of competence, conflicts of interest, non-transparency and protocol violations. It was effectively business as usual!

With event EE1, Kuruganti implied that the GEAC acted more like a servant for Mayco and its Monsanto master. Nothing has changed. She noted the ongoing revolving door between crop developers (even patent holders) and regulators. As before, developers-cum-lobbyists were actually sitting on regulatory bodies as event 142 was proceeding.

Under public-private-partnership arrangements, event 142 has been licensed to private companies for biosafety testing/commercialisation. Despite major concerns, the GEAC has pressed ahead with various trials. In May 2020, under lockdown, Kuruganti notes that the GEAC held a virtual meeting and sanctioned what were effectively final trials prior to commercialisation. She explains that important information and vital data is not in the public domain.

According to Kuruganti, the regulator sits with the crop developer and the companies and grant biosafety clearance, claiming all tests (soil, pollen flow, toxicity, etc) are complete. What is also disturbing is that these licensed companies have closed and opened under new names (with the same people in charge), thereby making accountability and liability fixing very difficult if something were to go wrong further down the line.

She concludes that the story of event 142 is even worse than event EE1:

Once again, they are certainly hiding things that they dont want conscientious scientists and aware citizens to see and know.

Taken together, the two webinars highlighted how hybrid Bt cotton is being deceptively used as a template for rolling out GM food crops: a fraud being used to promote another fraud in order to force unnecessary GMOs into Indian agriculture.

See the original post:
From Cotton to Brinjal: Fraudulent GMO Project in India Sustained by Deception - CounterPunch

Read More...

Page 9«..891011..2030..»


2024 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick