Biotechnology – StemCell Therapy

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Biotechnology is multidisciplinary field which has major impact on our lives. The technology is known since years which involves working with cells or cell-derived molecules for various applications. It has wide range of uses and is termed technology of hope which impact human health, well being of other life forms and our environment. It has revolutionized diagnostics and therapeutics; however, the major challenges to the human beings have been threats posed by deadly virus infections as avian flu, Chikungunya, Ebola, Influenza A, SARS, West Nile, and the latest Zika virus. Personalized medicine is increasingly recognized in healthcare system. In this chapter, the readers would understand the applications of biotechnology in human health care system. It has also impacted the environment which is loaded by toxic compounds due to human industrialization and urbanization. Bioremediation process utilizes use of natural or recombinant organisms for the cleanup of environmental toxic pollutants. The development of insect and pest resistant crops and herbicide tolerant crops has greatly reduced the environmental load of toxic insecticides and pesticides. The increase in crop productivity for solving world food and feed problem is addressed in agricultural biotechnology. The technological advancements have focused on development of alternate, renewable, and sustainable energy sources for production of biofuels. Marine biotechnology explores the products which can be obtained from aquatic organisms. As with every research area, the field of biotechnology is associated with many ethical issues and unseen fears. These are important in defining laws governing the feasibility and approval for the conduct of particular research.

Keywords: Stem Cell Research, Itaconic Acid, Levulinic Acid, Salmon Calcitonin, Agricultural Biotechnology

The term biotechnology was coined by a Hungarian engineer Karl Ereky, in 1919, to refer to the science and methods that permit products to be produced from raw materials with the aid of living organisms. Biotechnology is a diverse field which involves either working with living cells or using molecules derived from them for applications oriented toward human welfare using varied types of tools and technologies. It is an amalgamation of biological science with engineering whereby living organisms or cells or parts are used for production of products and services. The main subfields of biotechnology are medical (red) biotechnology, agricultural (green) biotechnology, industrial (white) biotechnology, marine (blue) biotechnology, food biotechnology, and environmental biotechnology (Fig. .). In this chapter the readers will understand the potential applications of biotechnology in several fields like production of medicines; diagnostics; therapeutics like monoclonal antibodies, stem cells, and gene therapy; agricultural biotechnology; pollution control ( bioremediation); industrial and marine biotechnology; and biomaterials, as well as the ethical and safety issues associated with some of the products.

Major applications of biotechnology in different areas and some of their important products

The biotechnology came into being centuries ago when plants and animals began to be selectively bred and microorganisms were used to make beer, wine, cheese, and bread. However, the field gradually evolved, and presently it is the use or manipulation of living organisms to produce beneficiary substances which may have medical, agricultural, and/or industrial utilization. Conventional biotechnology is referred to as the technique that makes use of living organism for specific purposes as bread/cheese making, whereas modern biotechnology deals with the technique that makes use of cellular molecules like DNA, monoclonal antibodies, biologics, etc. Before we go into technical advances of DNA and thus recombinant DNA technology, let us have the basic understanding about DNA and its function.

The foundation of biotechnology was laid down after the discovery of structure of DNA in the early 1950s. The hereditary material is deoxyribonucleic acid (DNA) which contains all the information that dictates each and every step of an individuals life. The DNA consists of deoxyribose sugar, phosphate, and four nitrogenous bases (adenine, guanine, cytosine, and thymine). The base and sugar collectively form nucleoside, while base, sugar, and phosphate form nucleotide (Fig. ). These are arranged in particular orientation on DNA called order or sequence and contain information to express them in the form of protein. DNA has double helical structure, with two strands being complimentary and antiparallel to each other, in which A on one strand base pairs with T and G base pairs with C with two and three bonds, respectively. DNA is the long but compact molecule which is nicely packaged in our nucleus. The DNA is capable of making more copies like itself with the information present in it, as order or sequence of bases. This is called DNA replication. When the cell divides into two, the DNA also replicates and divides equally into two. The process of DNA replication is shown in Fig. , highlighting important steps.

The double helical structure of DNA where both strands are running in opposite direction. Elongation of the chain occurs due to formation of phosphodiester bond between phosphate at 5 and hydroxyl group of sugar at 3 of the adjacent sugar of the nucleotide in 53 direction. The sugar is attached to the base. Bases are of four kinds: adenine (A), guanine (G) (purines), thymine (T), and cytosine (C) (pyrimidines). Adenine base pairs with two hydrogen bonds with thymine on the opposite antiparallel strand and guanine base pairs with three hydrogen bonds with cytosine present on the opposite antiparallel strand

The process of DNA replication. The DNA is densely packed and packaged in the chromosomes. The process requires the action of several factors and enzymes. DNA helicase unwinds the double helix. Topoisomerase relaxes DNA from its super coiled nature. Single-strand binding proteins bind to single-stranded open DNA and prevent its reannealing and maintains strand separation. DNA polymerase is an enzyme which builds a new complimentary DNA strand and has proofreading activity. DNA clamp is a protein which prevents dissociation of DNA polymerase. Primase provides a short RNA sequence for DNA polymerase to begin synthesis. DNA ligase reanneals and joins the Okazaki fragments of the lagging strand. DNA duplication follows semiconservative replication, where each strand serves as template which leads to the production of two complimentary strands. In the newly formed DNA, one strand is old and the other one is new (semiconservative replication). DNA polymerase can extend existing short DNA or RNA strand which is paired to template strand and is called primer. Primer is required as DNA polymerase cannot start the synthesis directly. DNA polymerase is capable of proofreading, that is, correction of wrongly incorporated nucleotide. One strand is replicated continuously with single primer, and it is called as leading strand. Other strand is discontinuous and requires the addition of several primers. The extension is done in the form of short fragments called as Okazaki fragments. The gaps are sealed by DNA ligase. Replication always occurs in 53 direction

DNA contains whole information for the working of the cell. The part of the DNA which has information to dictate the biosynthesis of a polypeptide is called a gene. The arrangement or order of nucleotides determines the kind of proteins which we produce. Each gene is responsible for coding a functional polypeptide. The genes have the information to make a complimentary copy of mRNA. The information of DNA which makes RNA in turn helps cells to incorporate amino acids according to arrangement of letters for making many kinds of proteins. These letters are transcribed into mRNA in the form of triplet codon, where each codon specifies one particular amino acid. The polypeptide is thus made by adding respective amino acids according to the instructions present on RNA. Therefore, the arrangement of four bases (adenine, guanine, cytosine, and thymine) dictates the information to add any of the 20 amino acids to make all the proteins in all the living organisms. Few genes need to be expressed continuously, as their products are required by the cell, and these are known as constitutive genes. They are responsible for basic housekeeping functions of the cells. However, depending upon the physiological demand and cells requirement at a particular time, some genes are active and some are inactive, that is, they do not code for any protein. The information contained in the DNA is used to make mRNA in the process of transcription (factors shown in Table ). The information of mRNA is used in the process of translation for production of protein. Transcription occurs in the nucleus and translation in the cytoplasm of the cell. In translation several initiation factors help in the assembly of mRNA with 40S ribosome and prevent binding of both ribosomal subunits; they also associate with cap and poly(A) tail. Several elongation factors play an important role in chain elongation. Though each cell of the body has the same genetic makeup, but each is specialized to perform unique functions, the activation and expression of genes is different in each cell. Thus, one type of cells can express some of its genes at one time and may not express the same genes some other time. This is called temporal regulation of the gene. In the body different cells express different genes and thus different proteins. For example, liver cell and lymphocyte, would express different genes. This is known as spatial regulation of the gene. Therefore, in the cells of the body, the activation of genes is under spatial regulation (cells present at different locations and different organs produce different proteins) and temporal regulation (same cells produce different proteins at different times). The proteins are formed by the information contained in the DNA and perform a variety of cellular functions. The proteins may be structural (responsible for cell shape and size), or they may be functional like enzymes, signaling intermediates, regulatory proteins, and defense system proteins. However, any kind of genetic defect results in defective protein or alters protein folding which can compromise the functioning of the body and is responsible for the diseases. Figure shows the outline of the process of transcription and translation with important steps.

Factors involved in transcription process

It shows the process of transcription and translation. Transcription occurs in the nucleus and requires the usage of three polymerase enzymes. RNApol I for rRNA, pol II for mRNA, and pol III for both rRNA and tRNA. RNApol II initiates the process by associating itself with seven transcription factors, TFIIA, TFIIB, TFIID, TFIIE, TFIIH, and TFIIJ. After the synthesis, preRNA transcript undergoes processing to form mRNA by removal of introns by splicing and polyadenylation and capping. Protein synthesis is initiated by formation of ribosome and initiator tRNA complex to initiation codon (AUG) of mRNA and involves 11 factors. Chain elongation occurs after sequential addition of amino acids by formation of peptide bonds. Then polypeptide can fold or conjugate itself to other biomolecules and may undergo posttranslational modifications as glycosylation or phosphorylation to perform its biological functions

The biotechnological tools are employed toward modification of the gene for gain of function or loss of function of the protein. The technique of removing, adding, or modifying genes in the genome or chromosomes of an organism to bring about the changes in the protein information is called genetic engineering or recombinant DNA technology (Fig. ). DNA recombination made possible the sequencing of the human genome and laid the foundation for the nascent fields of bioinformatics, nanomedicine, and individualized therapy. Multicellular organisms like cows, goats, sheep, rats, corn, potato, and tobacco plants have been genetically engineered to produce substances medically useful to humans. Genetic engineering has revolutionized medicine, enabling mass production of safe, pure, more effective versions of biochemicals that the human body produces naturally [2022].

The process of recombinant DNA technology. The gene of interest from human nucleus is isolated and cloned in a plasmid vector. The gene is ligated with the help of DNA ligase. The vector is transformed into a bacterial host. After appropriate selections, the gene is amplified when bacteria multiply or the gene can be sequenced or the gene can be expressed to produce protein

The technological advancements have resulted in (1) many biopharmaceuticals and vaccines, (2) new and specific ways to diagnose, (3) increasing the productivity and introduction of quality traits in agricultural crops, (4) the ways to tackle the pollutants efficiently for sustainable environmental practices, (5) helped the forensic experts by DNA fingerprinting and profiling, (6) fermentation technology for production of industrially important products. The list is very long with tremendous advancements and products which have boosted the economy of biotechnology sector worldwide [16]. The biotechnology industry and the products are regulated by various government organizations such as the US Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the US Department of Agriculture (USDA).

This fieldof biotechnology has many applications and is involved in production of recombinant pharmaceuticals, tissue engineering products, regenerative medicines such as stem cell and gene therapy, and many more biotechnology products for better human life (Fig. ). Biotechnological tools produce purified bio-therapeutic agents on industrial scales. These include both novel agents and agents formerly available only in small quantities. Crude vaccines were used in antiquity in China, India, and Persia. For example, vaccination with scabs that contained the smallpox virus was a practice in the East for centuries. In 1798 English country doctor Edward Jenner demonstrated that inoculation with pus from sores due to infection by a related cowpox virus could prevent smallpox far less dangerously. It marked the beginning of vaccination. Humans have been benefited incalculably from the implementation of vaccination programs.

Various applications of medical biotechnology

Tremendous progress has been made since the early recombinant DNA technology (RDT) experiments from which the livelyand highly profitablebiotechnology industry emerged. RDT has fomented multiple revolutions in medicine. Safe and improved drugs, accelerated drug discovery, better diagnostic and quick methods for detecting an infection either active or latent, development of new and safe vaccines, and completely novel classes of therapeutics and other medical applications are added feathers in its cap. The technology has revolutionized understanding of diseases as diverse as cystic fibrosis and cancer. Pharmaceutical biotechnology being one of the important sectors involves using animals or hybrids of tumor cells or leukocytes or cells ( prokaryotic, mammalian) to produce safer, more efficacious, and cost-effective versions of conventionally produced biopharmaceuticals. The launch of the new biopharmaceutical or drug requires screening and development. Mice were widely used as research animals for screening. However, in the wake of animal protection, animal cell culture offers accurate and inexpensive source of cells for drug screening and efficacy testing. Pharmaceutical biotechnologys greatest potential lies in gene therapy and stem cell-based therapy. The underlying cause of defect of many inherited diseases is now located and characterized. Gene therapy is the insertion of the functional gene in place of defective gene into cells to prevent, control, or cure disease. It also involves addition of genes for pro-drug or cytokines to eliminate or suppress the growth of the tumors in cancer treatment.

But the progress so far is viewed by many scientists as only a beginning. They believe that, in the not-so-distant future, the refinement of targeted therapies should dramatically improve drug safety and efficacy. The development of predictive technologies may lead to a new era in disease prevention, particularly in some of the worlds rapidly developing economies. Yet the risks cannot be ignored as new developments and discoveries pose new questions, particularly in areas as gene therapy, the ethics of stem cell research, and the misuse of genomic information.

Many bio-therapeutic agents in clinical use are biotech pharmaceuticals. Insulin was among the earliest recombinant drugs. Canadian physiologists Frederick Banting and Charles Best discovered and isolated insulin in 1921. In that time many patients diagnosed with diabetes died within a few years. In the mid-1960s, several groups reported synthesizing the hormone.

The first bioengineered drug, a recombinant form of human insulin, was approved by the US Food and Drug Administration (FDA) in 1982. Until then, insulin was obtained from a limited supply of beef or pork pancreas tissue. By inserting the human gene for insulininto bacteria, scientists were able to achieve lifesaving insulinproduction in large quantities. In the near future, patients with diabetes may be able to inhale insulin, eliminating the need for injections. Inhaled insulinproducts like Exubera were approved by the USFDA; however, it was pulled out and other products like Technosphere insulin (Afrezza) are under investigation. They may provide relief from prandial insulin. Afrezza consists of a pre-meal insulinpowder loaded into a cartridge for oral inhalation.

Technosphere technology: The technology allows administration of therapeutics through pulmonary route which otherwise were required to be given as injections. These formulations have broad spectrum of physicochemical characteristics and are prepared with a diverse assortment of drugs with protein or small molecule which may be hydrobhobic or hydrophilic or anionic or cationic in nature. The technology can have its applicability not only through pulmonary route but also for other routes of administration including local lung delivery.

The first recombinant vaccine, approved in 1986, was produced by cloning a gene fragment from the hepatitis B virus into yeast (Mercks Recombivax HB). The fragment was translated by the yeasts genetic machinery into an antigenic protein. This was present on the surface of the virus that stimulates the immune response. This avoided the need to extract the antigen from the serum of people infected with hepatitis B.

The Food and Drug administration (FDA) approved more biotech drugs in 1997 than in the previous several years combined. The FDA has approved many recombinant drugs for human health conditions. These include AIDS, anemia, cancers (Kaposis sarcoma, leukemia, and colorectal, kidney, and ovarian cancers), certain circulatory problems, certain hereditary disorders (cystic fibrosis, familial hypercholesterolemia, Gauchers disease, hemophilia A, severe combined immunodeficiency disease, and Turners syndrome), diabetic foot ulcers, diphtheria, genital warts, hepatitis B, hepatitis C, human growth hormone deficiency, and multiple sclerosis. Today there are more than 100 recombinant drugs and vaccines. Because of their efficiency, safety, and relatively low cost, molecular diagnostic tests and recombinant vaccines may have particular relevance for combating long-standing diseases of developing countries, including leishmaniasis (a tropical infection causing fever and lesions) and malaria.

Stem cell research is very promising and holds tremendous potential to treat neurodegenerative disorders, spinal cord injuries, and other conditions related to organ or tissue loss.

DNA analysis is another powerful technique which compares DNA pattern [14] after performing RFLP and probing it by minisatellite repeat sequence between two or more individuals. Its modification, DNA profiling (process of matching the DNA profiles for STS markers in two or more individuals; see chapter 18), which utilizes multilocus PCR analysis of DNA of suspect and victims, is very powerful and is useful in criminal investigation, paternity disputes, and so many other legal issues. The analysis is very useful in criminal investigations and involves evaluation of DNA from samples of the hair, body fluids, or skin at a crime scene and comparison of these with those obtained from the suspects.

The sequencing of the human genome in 2003, has given scientists an incredibly rich parts list with which to better understand why and how disease happens. It has given added power to gene expression profiling, a method of monitoring expression of thousands of genes simultaneously on a glass slide called a microarray. This technique can predict the aggressiveness of cancer.

The development of monoclonal antibodies in 1975 led to a medical revolution. The body normally produces a wide range of antibodiesthe immune system proteinsthat defend our body and eliminate microorganisms and other foreign invaders. By fusing antibody-producing cells with myeloma cells, scientists were able to generate antibodies that would, like magic bullets, bind with specific targets including unique markers, called antigenic determinants ( epitopes), on the surfaces of inflammatory cells. When tagged with radioisotopes or other contrast agents, monoclonal antibodies can help in detecting the location of cancer cells, thereby improving the precision of surgery and radiation therapy and showingwithin 48 hwhether a tumor is responding to chemotherapy.

The polymerase chain reaction, a method for amplifying tiny bits of DNA first described in the mid-1980s, has been crucial to the development of blood tests that can quickly determine exposure to the human immunodeficiency virus (HIV). Genetic testing currently is available for many rare monogenic disorders, such as hemophilia, Duchenne muscular dystrophy, sickle cell anemia, thalassemia, etc.

Another rapidly developing field is proteomics, which deals with analysis and identification of proteins. The analysis is done by two-dimensional gel electrophoresis of the sample and then performing mass spectrometric analysis for each individual protein. The technique may be helpful in detecting the disease-associated protein in the biological sample. They may indicate early signs of disease, even before symptoms appear. One such marker is C-reactive protein, an indicator of inflammatory changes in blood vessel walls that presage atherosclerosis.

Nanomedicine is a rapidly moving field. Scientists are developing a wide variety of nanoparticles and nanodevices, scarcely a millionth of an inch in diameter, to improve detection of cancer, boost immune responses, repair damaged tissue, and thwart atherosclerosis. The FDA has approved a paclitaxel albumin-stabilized nanoparticle formulation (Abraxane for injectable suspension, made by Abraxis BioScience) for the treatment of metastatic adenocarcinoma of the pancreas. Nanoparticles are being explored in heart patients in the USA as a way to keep their heart arteries open following angioplasty.

Therapeutic proteins are those, which can replace the patients naturally occurring proteins, when levels of the natural proteins are low or absent due to the disease. High-throughput screening, conducted with sophisticated robotic and computer technologies, enables scientists to test tens of thousands of small molecules in a single day for their ability to bind to or modulate the activity of a target, such as a receptor for a neurotransmitter in the brain. The goal is to improve the speed and accuracy of therapeutic protein or potential drug discovery while lowering the cost and improving the safety of pharmaceuticals that make it to market.

Many of the molecules utilized for detection also have therapeutic potential too, for example, monoclonal antibodies. The monoclonal antibodies are approved for the treatment of many diseases as cancer, multiple sclerosis, and rheumatoid arthritis. They are currently being tested in patients as potential treatments for asthma, Crohns disease, and muscular dystrophy. As the antibodies may be efficiently targeted against a particular cell surface marker, thus they are used to deliver a lethal dose of toxic drug to cancer cells, avoiding collateral damage to nearby normal tissues.

The manhas made tremendous progress in crop improvement in terms of yield; still the ultimate production of crop is less than their full genetic potential. There are many reasons like environmental stresses (weather condition as rain, cold, frost), diseases, pests, and many other factors which reduce the ultimate desired yield affecting crop productivity. The efforts are going on to design crops which may be grown irrespective of their season or can be grown in frost or drought conditions for maximum utilization of land, which would ultimately affect crop productivity [24]. Agricultural biotechnology aims to introduce sustainable agriculturalpractices with best yield potential and minimal adverse effects on environment (Fig. ). For example, combating pests was a major challenge. Thus, the gene from bacterium , the Bt gene, that functions as insect-resistant gene when inserted into crop plants like cotton, corn, and soybean helps prevent the invasion of pathogen, and the tool is called . This management is helpful in reducing usage of potentially dangerous pesticides on the crop. Not only the minimal or low usage of pesticides is beneficial for the crop but also the load of the polluting pesticides on environment is greatly reduced [24].

Various applications of agricultural biotechnology

The gene comes from the soil bacterium .

The gene produces crystal proteins called Cry proteins. More than 100 different variants of the Bt toxins have been identified which have different specificity to target insect lepidoptera. For eg., CryIa for butterflies and CRYIII for beetles.

These Cry proteins are toxic to larvae of insects like tobacco budworm, armyworm, and beetles.

The Cry proteins exist as an inactive protoxins.

These are converted into active toxin in alkaline pH of the gut upon solubilization when ingested by the insect.

After the toxin is activated, it binds to the surface of epithelial cells of midgut and creates pores causing swelling and lysis of cells leading to the death of the insect (larva).

The genes (cry genes) encoding this protein are isolated from the bacterium and incorporated into several crop plants like cotton, tomato, corn, rice, and soybean.

The proteins encoded by the following cry genes control the pest given against them:

Cry I Ac and cry II Ab control cotton bollworms.

Cry I Ab controls corn borer.

Cry III Ab controls Colorado potato beetle.

Cry III Bb controls corn rootworm.

A nematode infects tobacco plants and reduces their yield.

The specific genes (in the form of cDNA) from the parasite are introduced into the plant using -mediated transformation.

The genes are introduced in such a way that both sense/coding RNA and antisense RNA (complimentary to the sense/coding RNA) are produced.

Since these two RNAs are complementary, they form a double-stranded RNA (ds RNA).

This neutralizes the specific RNA of the nematode, by a process called RNA interference.

As a result, the parasite cannot multiply in the transgenic host, and the transgenic plantis protected from the pest.

These resistant crops result in reduced application of pesticides. The yield is high without the pathogen infestations and insecticides. This also helps to reduce load of these toxic chemicals in the environment.

The transformation techniques and their applications are being utilized to develop rice, cassava, and tomato, free of viral diseases by International Laboratory for Tropical Agricultural Biotechnology (ILTAB). ILTAB in 1995 reported the first transfer of a resistance gene from a wild-type species of rice to a susceptible cultivated rice variety. The transferred gene expressed and imparted resistance to crop-destroying bacterium Xanthomonas oryzae. The resistant gene was transferred into susceptible rice varieties that are cultivated on more than 24 million hectares around the world [6].

The recombinant DNA technology reduces the time between the identification of a particular gene to its application for betterment of crops by skipping the labor-intensive and time-consuming conventional breeding [3]. For example, the alteration of known gene in plant for the improvement of yield or tolerance to adverse environmental conditions or resistance to insect in one generation and its inheritance to further generations. Plant cell and tissue culture techniques are one of the applications where virus-free plants can be grown and multiplied irrespective of their season on large scale (micropropogation), raising haploids, or embryo rescue. It also opens an opportunity to cross two manipulated varieties or two incompatible varieties (protoplast culture) for obtaining best variety for cultivation.

With the help of technology, new, improved, and safe agricultural products may emerge which would be helpful for maintaining contamination-free environment. Biotechnology has the potential to produce:

Crops are engineered to have desirable nutrients and better taste (e.g., tomatoes and other edible crops with increased levels of vitamin C, vitamin E, and/or beta-carotene protect against the risk of some prevalent chronic diseases and rice with increased iron levels protects against anemia)

Insect- and disease-resistant plants

Genetic modification avoids nonselective changes

Longer shelf life of fruits and vegetables

The potential of biotechnology may contribute to increasing agricultural, food, and feed production, protecting the environment, mitigating pollution, sustaining agricultural practices, and improving human and animal health. Some agricultural crops as corn and marine organisms can be potential alternative for biofuel production. The by-products of the process may be processed to produce other chemical feedstocks for various products. It is estimated that the worlds chemical and fuel demand could be supplied by such renewable resources in the first half of the next century [5].

Food biotechnology is an emerging field, which can increase the production of food, improving its nutritional content and improving the taste of the food. The food is safe and beneficial as it needs fewer pesticides and insecticides. The technology aims to produce foods which have more flavors, contain more vitamins and minerals, and absorb less fat when cooked. Food biotechnology may remove allergens and toxic components from foods, for their better utility [6, 7].

Environmental biotechnology grossly deals with maintenanceof environment, which is pollution-free, the water is contamination-free, and the atmosphere is free of toxic gases. Thus, it deals with waste treatment, monitoring of environmental changes, and pollution prevention. Bioremediation in which utilization of higher living organisms (plants: phytoremediation) or certain microbial species for decontamination or conversion of harmful products is done is the main application of environmental biotechnology. The enzyme bioreactors are also being developed which would pretreat some industrial and food waste components and allow their removal through the sewage system rather than through solid waste disposal mechanisms. The production of biofuel from waste can solve the fuel crisis (biogas). Microbes may be engineered to produce enzymes required for conversion of plant and vegetable materials into building blocks for biodegradable plastics. In some cases, the by-products of the pollution-fighting microorganisms are themselves useful. For example, methane can be derived from a form of bacteria that degrades sulfur liquor, a waste product of paper manufacturing. This methane thus obtained is used as a fuel or in other industrial processes. Insect- and pest-resistant crops have reduced the use and environmental load of insecticides and pesticides. Insect-protected crops allow for less potential exposure of farmers and groundwater to chemical residues while providing farmers with season-long control.

The utilizationof biotechnological tools (bioprocessing) for the manufacturing of biotechnology-derived products (fuels, plastics, enzymes, chemicals, and many more compounds) on industrial scale is industrial biotechnology. The aim is to develop newer industrial manufacturing processes and products, which are economical and better than preexisting ones with minimal environmental impact. In industrial biotechnology, (1) microorganisms are being explored for producing material goods like fermentation products as cheese; (2) biorefineries where oils, sugars, and biomass may be converted into biofuels, bioplastics, and biopolymers; (3) and value-added chemicals from biomass. The utilization of modern techniques can improve the efficiency and reduces the environmental impacts of industrial processes like textile, paper, pulp, and chemical manufacturing. For example, development and usage of biocatalysts, such as enzymes, to synthesize chemicals and development of antibiotics and better tasting liquors and their usage in food industry have provided safe and effective processing for sustainable productions. Biotechnological tools in the textile industry are utilized for the finishing of fabrics and garments. Biotechnology also produces spider silk and biotech-derived cotton that is warmer and stronger and has improved dye uptake and retention, enhanced absorbency, and wrinkle and shrink resistance.

Biofuels may be derived from photosynthetic organisms, which capture solar energy, transform it in other products like carbohydrates and oils, and store them. Different plants can be used for fuel production:

Bioethanol can be obtained from sugar (as sugarcane or sugar beet) or starch (like corn or maize). These are fermented to produce ethanol, a liquid fuel commonly used for transportation.

Biodiesel can be obtained from natural oils from plants like oil palm, soybean, or algae. They can be burned directly in a diesel engine or a furnace, or blended with petroleum, to produce fuels such as biodiesel.

Wood and its by-products can be converted into liquid biofuels, such as methanol or ethanol, or into wood gas. Wood can also be burned as solid fuel, like the irewood.

In these kinds of biological reaction, there are many renewable chemicals of economic importance coproduced as side streams of bioenergy and biofuels as levulinic acid, itaconic acid, and sorbitol. These have tremendous economic potential and their fruitful usage would depend upon the collaboration for research and development between the government and the private sector.

The enzymeshave big commercial and industrial significance. They have wide applications in food industry, leather industry, pharmaceuticals, chemicals, detergents, and research. In detergents the alkaline protease, subtilisin (from Bacillus subtilis), was used by Novo Industries, Denmark. The production of enzymes is an important industrial application with world market of approximately 5 billion dollars. The enzymes can be obtained from animals, plants, or microorganisms. The production from microorganisms is preferred as they are easy to maintain in culture with simple media requirements and easy scale-up. The important enzymes for the industrial applications are in food industry, human application, and research. A few animal enzymes are also important as a group of proteolytic enzymes, for example, plasminogen activators, which act on inactive plasminogen and activate it to plasmin, which destroys fibrin network of blood clot. Some of the plasminogen activators are urokinase and tissue plasminogen activators (t-PA). Urokinase (from urine) is difficult to obtain in ample quantity; thus, t-PA is obtained from cells grown in culture medium. Streptokinase (bacterial enzyme) is also a plasminogen activator but is nonspecific and immunogenic.

Enzyme engineering is also being tried where modifications of specific amino acid residue are done for improving the enzyme properties. One of the enzymes chymosin (rennin) coagulates milk for cheese manufacturing.

The enzymes can be produced by culturing cells, growing them with appropriate substrates in culture conditions. After optimum time the enzymes may be obtained by cell disruption (enzymatic/freezethaw/osmotic shock) followed by preparative steps (centrifugation, filtration), purification, and analysis. The product is then packaged and ultimately launched in the market.

After their production, they can be immobilized on large range of materials (agar, cellulose, porous glass, or porous alumina) for subsequent reuse. Some of the important industrial enzymes are -amylase (used for starch hydrolysis), amyloglucosidase (dextrin hydrolysis), -galactosidase (lactose hydrolysis), aminoacylase (hydrolysis of acylated L-amino acids), glucose oxidase (oxidation of glucose), and luciferase (bioluminescence). Some of the medically important enzymes are urokinase and t-PA for blood clot removal and L-asparaginase for removal of L-asparagine essential for tumor growth and thus used for cancer chemotherapy in leukemia.

The energyrequirement of present population is increasing and gradually fossil fuels are rapidly depleting. Thus, renewable energy sources like solar energy and wind-, hydro-, and biomass-based energy are being explored worldwide. One of the feedstocks may be microalgae, which are fast-growing, photosynthetic organisms requiring carbon dioxide, some nutrients, and water for its growth. They produce large amount of lipids and carbohydrates, which can be processed into different biofuels and commercially important coproducts. The production of biofuels using algal biomass is advantageous as they (1) can grow throughout the year and thus their productivity is higher than other oil seed crops, (2) have high tolerance to high carbon dioxide content, (3) utilize less water, (4) do not require herbicides or pesticides with high growth potential (waste water can be utilized for algal cultivation), (5) can sustain harsh atmospheric conditions, and (6) do not interfere with productivity of conventional crops as they do not require agricultural land. The production of various biofuels from algae is schematically represented in Fig. .

Different biofuel productions by using microalgae. The algae use sunlight, CO2, water, and some nutrients

Algae can serve as potential source for biofuel production; however, biomass production is low. The production has certain limitations, as cultivation cost is high with requirement of high energy[1].

Marine or aquatic biotechnology also referred to as blue biotechnology deals with exploring and utilizing the marine resources of the world. Aquatic or marine life has been intriguing and a source of livelihood for many since years. As major part of earth is acquired by water, thus nearly 7580% types of life forms exist in oceans and aquatic systems. It studies the wide diversity found in the structure and physiology of marine organisms. They are unique in their own ways and lack their equivalent on land. These organisms have been explored and utilized for numerous applications as searching new treatment for cancer or exploring other marine resources, because of which the field is gradually gaining momentum and economic opportunities [19]. The global economic benefits are estimated to be very high. The field aims to:

Fulfill the increasing food supply needs

Identify and isolate important compounds which may benefit health of humans

Manipulate the existing traits in sea animals for their improvement

Protect marine ecosystem and gain knowledge about the geochemical processes occurring in oceans

Some of the major applications are discussed:

Aquaculture: Aquaculture refers to the growth of aquatic organisms in culture condition for commercial purposes. These animals may be shellfish, finfish, and many others. Mariculture refers to the cultivation of marine animals. Their main applications are in food, food ingredients, pharmaceuticals, and fuels, the products are in high demand, and various industries are in aquaculture business, for example, crawfish farming (Louisiana), catfish industry (Alabama and Mississippi Delta), and trout farming (Idaho and West Virginia).

Transgenic species of salmon with growth hormone gene has accelerated growth of salmons.

Molt-inhibiting (MIH) from blue crabs leads to soft-shelled crab.

: Anovel protein antifreeze protein (AFP) was identified. AFPs were isolated from Northern cod (bottom-dwelling fish) living at the Eastern Canada coast and teleosts living in extremely cold weather of Antarctica. AFPs have been isolated from Osmerus mordax (smelt), Clupea harengus (herring), Pleuronectes americanus (winter flounder), and many others. Due to antifreeze properties (lowering the minimal freezing temperature by 23 C), the gene has potential for raising plants which are cold tolerant (e.g., tomatoes).

Medicinal applications: For osteoporosis, salmon calcitonin (calcitonin is thyroid hormone promoting calcium uptake and bone calcification) with 20 times higher bioactivity is available as injection and nasal spray.

Hydroxyapatite (HA): Obtained from coral reefs and is an important component of bone and cartilage matrix. Its implants are prepared by Interpore Internationals which may be used for filling gaps in fractured bones.

Byssal fibers: Are protein-rich superadhesive which have elastic properties obtained from mussels (Mytilus edulis). Their isolation would not be very economical, but they can have wide applications in surgical sutures, artificial tendons, and ligament grafts.

Many anti-inflammatory, analgesic, anticancerous compounds have been identified from sea organisms which can have tremendous potential for human health.

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An Introduction to Biotechnology - PMC - PubMed Central (PMC)

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Biotechnology, M.S. | Florida Tech – FIT

♫ Monday, October 31st, 2022

Get a Master's in Biotechnology

For more than 50 years, Florida Tech has challenged engineering, science, and technology students with a rigorous educational curriculum rooted in independent and collaborate research, interdisciplinary classroom studies, and a myriad of real-world learning experiences.

Florida Techs masters in biotechnology program is just one of four graduate level specializations in biology, the others being cell and molecular biology, ecology, and marine biology.

The degree program is flexible with a wide range of course options and a minimum of required courses. Biotechnology curriculum covers general biological and chemical sciences, bioinstrumentation, bioinformatics, microbiology, molecular biology, and cell biology. Research is also a major part of studying at Florida Tech, including opportunities for both on- and off-campus laboratory work, and internships on a variety of projects in molecular medicine, diagnostics, agriculture, and environmental science. Students also have a heavy emphasis on enhancing communication skills through writing reports and giving oral presentations.

Developing medical and environmental technologies and solutions to improve the lives of people and habitats around the world is the focus for both students and faculty in the masters in biotechnology program. With some of the most diverse environments on the planet located near Florida Techs campus, this rapidly advancing field uses living organisms and their components to create products and solve challenges.

As a national research university, Florida Tech provides the tools and skills necessary for students earning a masters in biotechnology to conduct cutting-edge research in all areas of biological sciences, including bacterial genetics, climate change, polar biology, Alzheimers disease, and more. This research-based focus not only prepares graduates for the type of work theyll do in their future career; it also provides an opportunity for their program results to be published in respected scientific journals. Building experience in a myriad of biological sciences disciplines, as well as mastering communication skills, gives students a competitive advantage when being considered by employers.

Students have access to state-of-the-art facilities on campus at the F. W. Olin Physical Sciences Center and the F.W. Olin Life Sciences Building. These facilities offer cutting-edge research laboratories and instrumentation, including gene sequencing, recombinant DNA technology, and tissue culture. Multidisciplinary laboratories offer high-resolution microscopy and imaging, an indoor aquaculture facility, a climate change institute, rooms for NMR spectrometers, photochemistry, glassblowing and computational chemistry, and a four-acre oceanfront marine lab with ready access to field sites.

Other facilities add to the reasons why Florida Tech is a leader in science education:

Biology at Florida Tech is not just something you studyits something you go out into the field and do. A Florida Tech biotechnology masters program engages students in relevant, topical research project in a multidisciplinary learning environment.

The professors in the masters in biotechnology program are experienced, doctoral-level instructors with both research and teaching experience in a wide range of areas related to biotechnology. This includes microbial genetics, bioinformatics, human disease, plant biotechnology, gene modification, sensory systems, nanotechnology, and tissue engineering.

Professors in the graduate biology department aim to create leaders in the field of biology who are ready to begin a career capable of contributing their expertise to solve complex challenges. The biotechnology masters degree program offers extensive student- and faculty-led research opportunities and internships that provide real-world experiences.

Florida Tech is the perfect place for a biotechnology masters degree. The 130-acre campus is located on the Space Coast (so named because of the presence of NASA and the Kennedy Space Center on Cape Canaveral just north of us), minutes away from the Indian River Lagoon, the most diverse estuary in North America.

The area has one of the largest high-tech workforce in the country, with more than 5,000 high-tech corporations and government and military organizations located nearby. This workforce also provides an abundance of internship and employment opportunities. the many local, state, and national agencies, marine environmental consulting firms, public aquaria, mariculture companies, and private marine research organizations offer internships and employment for graduates. Just a few hours away from the Florida Keys and the Everglades, Florida Tech is easily the best candidate for a biotechnology masters degree program.

The multidisciplinary biotechnology program prepares graduates for their career using the latest body of knowledge in the industry and by providing excellent research facilities for conducting state-of-the-art biotechnology research. This real-world experience builds a highly competitive resume that equips graduates for future employment.

Research topics include:

In addition to research activities, graduate students can become members of the scientific societies that support the biotechnology field. Based on laboratory productivity, there may also be a chance to attend scientific meetings and present research findings.

Students in this program also collaborate with graduate students in the closely related areas of nanotechnology and biomedical engineering. Internships can also be arranged anywhere in the country during any semester in the second year of the program.

Biotechnology careers can be found in a variety of positions across many different industries, from research and development to medicine and pharmaceuticals, manufacturing, and environmental technology. Graduates with a masters of science in biotechnology from Florida Tech gain new scientific insights and prepare for careers in biotech managementa dynamic and continually growing career option.

The Occupational Outlook Handbook, published by the US Department of Labors Bureau of Labor Standards (BLS), provides information about specific jobs including median annual pay, working conditions and job outlook, among other things.

According to Bureau, job growth for biological scientists is expected to grow more than 20% through 2018. Employment of biological technicians is projected to grow 10% through 2022. Among biotechnology careers, scientists will be needed to develop genetically engineered crops that increase yields and reduce the amount of pesticides and fertilizer. Job growth will also be in demand for scientists to discover new ways to clean and preserve the environment as well as develop alternative sources of energy, such as biofuels and better sources of renewable biomass.

Employers that have recruited Florida Tech graduates for biotechnology careers include:

Florida Tech students graduating with a masters in biotechnology join cutting-edge companies around the world solving complex biological challenges. Some graduates prefer to continue their academic career and enter a doctoral program in biological sciences at Florida Tech. Along with a chance to further their research, earning a doctorate can increase a students lifelong earning potential and position them as a subject-matter expert.

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What is Biotech? Types of Biotech + More | Built In

♫ Monday, October 31st, 2022

As mentioned above, biotech occupies a variety of use cases to solve challenges throughout many industries. To define the needs, capabilities, and ethics involved in each application, biotech companies can be broken down into various categories based on the solutions they seek to create.

Red biotech involves all practices related to the research and creation of medicinal and veterinary products, including vaccines, antibiotics and molecular diagnosis techniques. Genetic engineering techniques are also utilized to research disease causes and develop potential cures through manipulation techniques.

All biotech companies and products related to the production of food fallinto the Yellow Biotechnology categorization. One of the most popular examples of Yellow biotechis the process of fermentation, in which bacteria or other microorganisms break down substances and transform their chemical makeup.

White biotech refers to biotech practices utilized in industrial manufacturing, focused on redesigning chemical makeups to reduce multiple issues that have been present since the dawn of the Industrial Revolution. White biotechnology aims to reduce the consumption of resources and products during manufacturing by enabling more energy efficient processes, reducing pollution to offset the growing climate crisis.

Focused entirely on transgenics, or genetic modification, Green Biotechnology focuses entirely on creating new plant varietiesfor specific uses, such as the production of biopesticides and biofertilizers. Biotechnologists in this category splice single or multiple genes into an organism to solve for specific deficiencies within a plant. Genes can either come from the same species or others, resulting in healthier ecosystems and more resources available for harvesting.

While Green Biotechnology focuses on the introduction of genes into specific plants for a multitude of uses, Grey Biotechnology is the practice of introducing modified or unmodified plants and microorganisms into specific environments to remove carbons, metals and other pollutants or contaminants while enhancing overall biodiversity. Green and Grey biodiversity used in tandem can lead to profound changes in ecosystems on the verge of collapse.

Blue biotechnology refers to the use and exploitation of marine-based resources to create products that benefit various industries. Due to the prevalence of water on Earth, Blue Biotechnology presents the greatest range of biodiversity, and accordingly, the highest overall potential for future biotech developments across industries. From alternative energy to vitamin production, Blue Biotechnology has led to enormous breakthroughs in quality of life. The introduction of transgenic fish, plants and microorganisms into marine environments can lead to less pollution, a higher abundance of resources and a better understanding of many unexplored regions of the world.

While not directly involved in the creation of biotech products, these categorizations exist to represent concerns surrounding biotech implementation:

Gold biotech refers to the use of data, analytics and computing models to predict and enable biotech production.

The handling of compliance, legality and ethical biotech concerns fall into the category of Violet Biotechnology.

In contrast to the ethical standards of biotechnology, Dark Biotechnology refers to the creation of weapons and warfare products that intend to do harm and are produced through chemical manipulation or other biotech methods.

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What is Biotech? Types of Biotech + More | Built In

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Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022…

♫ Monday, October 31st, 2022

Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022 EORTC/NCI/AACR Symposium Business Wire

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Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022...

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Where Does Sorrento Therapeutics Inc (SRNE) Stock Fall in the Biotechnology Field After It Is Up 6.58% This Week? – InvestorsObserver

♫ Monday, October 31st, 2022

Where Does Sorrento Therapeutics Inc (SRNE) Stock Fall in the Biotechnology Field After It Is Up 6.58% This Week? InvestorsObserver

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Where Does Sorrento Therapeutics Inc (SRNE) Stock Fall in the Biotechnology Field After It Is Up 6.58% This Week? - InvestorsObserver

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Where Does Veru Inc (VERU) Stock Fall in the Biotechnology Field After It Is Lower By -5.84% This Week? – InvestorsObserver

♫ Monday, October 31st, 2022

Where Does Veru Inc (VERU) Stock Fall in the Biotechnology Field After It Is Lower By -5.84% This Week? InvestorsObserver

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Where Does Veru Inc (VERU) Stock Fall in the Biotechnology Field After It Is Lower By -5.84% This Week? - InvestorsObserver

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Zero emission vehicles: first Fit for 55 deal will end the sale of new CO2 emitting cars in Europ… – Modern Diplomacy

♫ Monday, October 31st, 2022

Zero emission vehicles: first Fit for 55 deal will end the sale of new CO2 emitting cars in Europ... Modern Diplomacy

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Zero emission vehicles: first Fit for 55 deal will end the sale of new CO2 emitting cars in Europ... - Modern Diplomacy

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The Worldwide Biotechnology Industry is Expected to Reach $2234 Billion by 2027 – ResearchAndMarkets.com – Business Wire

♫ Thursday, September 29th, 2022

DUBLIN--(BUSINESS WIRE)--The "Biotechnology Market Research Report by Technology (Cell-based Assays, Chromatography, and DNA Sequencing), Application, Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.

The Global Biotechnology Market size was estimated at USD 876.74 billion in 2021, USD 1,023.15 billion in 2022, and is projected to grow at a CAGR 16.87% to reach USD 2,234.84 billion by 2027.

Competitive Strategic Window:

The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix evaluates and categorizes the vendors in the Biotechnology Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:

The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

The report provides insights on the following pointers:

1. Market Penetration: Provides comprehensive information on the market offered by the key players

2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets

3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments

4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players

5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:

1. What is the market size and forecast of the Global Biotechnology Market?

2. What are the inhibiting factors and impact of COVID-19 shaping the Global Biotechnology Market during the forecast period?

3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Biotechnology Market?

4. What is the competitive strategic window for opportunities in the Global Biotechnology Market?

5. What are the technology trends and regulatory frameworks in the Global Biotechnology Market?

6. What is the market share of the leading vendors in the Global Biotechnology Market?

7. What modes and strategic moves are considered suitable for entering the Global Biotechnology Market?

Market Dynamics

Drivers

Restraints

Opportunities

Challenges

Companies Mentioned

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

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The Worldwide Biotechnology Industry is Expected to Reach $2234 Billion by 2027 - ResearchAndMarkets.com - Business Wire

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Argentina: Promotion of modern biotechnology and nanotechnology – Lexology

♫ Thursday, September 29th, 2022

In brief

By National Law No. 27,685 ("Law"), published on 16 September 2022, Law No. 26,270 was amended, expanding throughout the entire national territory the promotion regime for the development and production of modern biotechnology and nanotechnology. The regime will be in force up to 31 December 2034.

The Law set forth the following tax benefits: (i) the accelerated amortization of the capital goods, special equipment, and parts or elements forming those new goods, which were acquired for the project; (ii) the anticipated refund for the VAT corresponding to the goods acquired for the project; and (iii) the granting of a tax credit bond equivalent to 50% of expenses paid for hiring investigative and development services from institutions that are part of the national public system of science, technology and innovation. The tax credit bond will be valid for 10 years and it will only be transferable once.

In focus

The Law includes the concept of nanotechnology in the definition of "Modern Biotechnology", which means every technological application based on rational knowledge and scientific principles that derive from biology, biochemistry, microbiology, bioinformatics, molecular biology and genetic engineering, or that uses live organisms or parts of them, either for the production of goods and services, or for the substantial improvement of products and productive processes.

The Law set forth the following tax benefits:

Click here to download the Spanish version.

Content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee similar outcomes. For more information, please visit:www.bakermckenzie.com/en/client-resource-disclaimer.

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Allarity Therapeutics Appoints Seasoned Biotechnology Executive Jerry McLaughlin to Board of Directors – GlobeNewswire

♫ Thursday, September 29th, 2022

Press release

Cambridge, MA U.S.A. (September 26, 2022) Allarity Therapeutics, Inc. (Nasdaq: ALLR) (Allarity or the Company), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, today announced the appointment of Jerry McLaughlin as a new member of its Board of Directors, effective October 1, 2022.

Mr. McLaughlin is a highly accomplished biotechnology executive with extensive experience in financing, drug development, licensing, commercialization, and product lifecycle management. Mr. McLaughlin is expected to serve on the compensation, and audit committees as an independent director.

I am delighted that Jerry has chosen to join Allaritys board at this crucial time in our evolution, said Dr. Duncan Moore, Allaritys Chairman of the Board. His operational experience in clinical stage therapeutic development and capital markets acumen will be of great value as we continue to implement the Companys combination therapy-focused strategy.

Mr. McLaughlin said: I firmly believe Allarity Therapeutics is in a unique position to become a leader within the personalized medicine space by developing novel combination oncology therapies together with the Companys unique DRP companion diagnostics. Allaritys recent strategic shift is aligned with the ongoing patient and market realities in oncology, as we continue to see substantially higher patient benefits with combination therapies. I look forward to supporting the CEO, Jim Cullem, and the rest of the Allarity team in unlocking both the clinical and commercial potential of this strategy.

Mr. McLaughlin has three decades of experience in leading operational and executive management roles. He made key contributions to significant life science milestones, including product launches, acquisitions, and financings. He is currently serving as CEO and Board Member of Life Biosciences, LLC, a development-stage biopharmaceutical company advancing therapeutics for patients with neurological and psychiatric diseases. Prior to serving in this role, he was President, CEO, and Member of the Board of Directors at Neos Therapeutics (acquired by Aytu BioScience.) Before joining Neos Therapeutics, he served as President, CEO, and Member of the Board of Directors at AgeneBio, Inc. Earlier in his career, he held corporate leadership roles at NuPathe, Inc., Endo Pharmaceuticals Inc., and Merck & Co., Inc. He received his B.A. from Dickinson College and his MBA from Villanova University in Pennsylvania.

About Allarity Therapeutics

Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; dovitinib, a post-Phase 3 pan-tyrosine kinase inhibitor; and the European rights to IXEMPRA (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis, a liposomal formulation of cisplatin and its accompanying DRP, being developed via a partnership with Chosa ApS, an affiliate of Smerud Medical Research International, for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Companys website at http://www.Allarity.com.

About the Drug Response Predictor DRP Companion Diagnostic

Allarity uses its drug-specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP score, the therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA from patient biopsies. The DRP platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA. The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer reviewed literature.

Follow Allarity on Social Media

Facebook: https://www.facebook.com/AllarityTx/ LinkedIn: https://www.linkedin.com/company/allaritytx/ Twitter: https://twitter.com/allaritytx

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allaritys current expectations or forecasts of future events. The words anticipates, believe, continue, could, estimate, expect, intends, may, might, plan, possible, potential, predicts, project, should, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements related to clinical and commercial potential due to the Company advancing dovitinib in combination with another therapeutic candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA for the treatment of metastatic breast cancer, and statements relating to the effectiveness of the Companys DRP companion diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug. Any forward-looking statements in this press release are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to,the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the risk that the current COVID-19 pandemic will impact the Companys current and future clinical trials and the timing of the Companys preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our Form S-1 registration statementon file with theSecurities and Exchange Commission, available at the Securities and Exchange Commissions website atwww.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Companys subsequent filings with theSecurities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

###

Company Contact:

Thomas JensenSenior V.P. of Investor Relationsinvestorrelations@allarity.com

Investor Relations:

Chuck PadalaLifeSci Advisors+1(646) 627-8390chuck@lifesciadvisors.comU.S. Media Contact:

Mike Beyer Sam Brown, Inc. +1 (312) 961-2502 mikebeyer@sambrown.com

EU Media Contact:

Thomas PedersenCarrotize PR & Communications +45 6062 9390tsp@carrotize.com

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Allarity Therapeutics Appoints Seasoned Biotechnology Executive Jerry McLaughlin to Board of Directors - GlobeNewswire

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CIA Just Invested In Woolly Mammoth Resurrection Tech – The Intercept

♫ Thursday, September 29th, 2022

As a rapidly advancing climate emergency turns the planet ever hotter, the Dallas-based biotechnology company Colossal Biosciences has a vision: To see the Woolly Mammoth thunder upon the tundra once again. Founders George Church and Ben Lamm have already racked up an impressive list of high-profile funders and investors, including Peter Thiel, Tony Robbins, Paris Hilton, Winklevoss Capital and, according to the public portfolio its venture capital arm released this month, the CIA.

Colossal says it hopes to use advanced genetic sequencing to resurrect two extinct mammals not just the giant, ice age mammoth, but also a mid-sized marsupial known as the thylacine, or Tasmanian tiger, that died out less than a century ago. On its website, the company vows: Combining the science of genetics with the business of discovery, we endeavor to jumpstart natures ancestral heartbeat.

In-Q-Tel, its new investor, is registered as a nonprofit venture capital firm funded by the CIA. On its surface, the group funds technology startups with the potential to safeguard national security. In addition to its long-standing pursuit of intelligence and weapons technologies, the CIA outfit has lately displayed an increased interest in biotechnology and particularly DNA sequencing.

Why the interest in a company like Colossal, which was founded with a mission to de-extinct the wooly mammoth and other species? reads an In-Q-Tel blog post published on September 22. Strategically, its less about the mammoths and more about the capability.

Biotechnology and the broader bioeconomy are critical for humanity to further develop. It is important for all facets of our government to develop them and have an understanding of what is possible, Colossal co-founder Ben Lammwrote in an email to The Intercept. (A spokesperson for Lamm stressed that while Thiel provided Church with$100,000 in funding to launchthe woolly mammoth project that became Colossal, he is not a stakeholderlike Robbins, Hilton, Winklevoss Capital, and In-Q-Tel.)

Colossal uses CRISPR gene editing, a method of genetic engineering based on a naturally occurring type of DNA sequence. CRISPR sequences present on their own in some bacterial cells and act as an immune defense system, allowing the cellto detect and excise viral material thattries to invade. The eponymous gene editing technique was developed to function the same way, allowing users to snip unwanted genes and program a more ideal version of the genetic code.

CRISPR is the use of genetic scissors, Robert Klitzman, a bioethicist at Columbia University and a prominent voice of caution on genetic engineering, told The Intercept. Youre going into DNA, which is a 3-billion-molecule-long chain, and clipping some of it out and replacing it. You can clip out bad mutations and put in good genes, but these editing scissors can also take out too much.

The embrace of this technology, according to In-Q-Tels blog post, will help allow U.S. government agencies to read, write, and edit genetic material, and, importantly, tosteerglobal biological phenomena that impact nation-to-nation competition whileenabling the United States to help set the ethical, as well as the technological, standards for its use.

In-Q-Tel did not respond to The Intercepts requests for comment.

In recent years, the venture firms portfolio has expanded to include Ginkgo Bioworks, a bioengineering startup focused on manufacturing bacteria for biofuel and other industrial uses; Claremont BioSolutions, a firm that produces DNA sequencing hardware; Biomatrica and T2 Biosystems, two manufacturers for DNA testing components; and Metabiota, an infectious disease mapping and risk analysis database powered by artificial intelligence. As The Intercept reported in 2016, In-Q-Tel also invested in Clearista, a skincare brand that removes a thin outer epidermal layer to reveal a fresher face beneath it and allow DNA collection from the skin cells scraped off.

President Joe Bidens administration signaled its prioritization of related advances earlier this month, when Biden signed an executive order on biotechnology and biomanufacturing. The order includes directives to spur public-private collaboration, bolster biological risk management, expand bioenergy-based products, and engage the international community to enhance biotechnology R&D cooperation in a way that is consistent with United States principles and values.

The governments penchant for controversial biotechnology long predates the Biden administration. In 2001, a New York Times investigation found that American defense agencies under Presidents George W. Bush and Bill Clinton had continued to experiment with biological weapons, despite a 1972 international treaty prohibiting them. In 2011, The Guardian revealed that the CIA under President Barack Obama organized a fake Hepatitis B vaccine drive in Pakistan that sought to locate family members of Osama bin Laden through nonconsensual DNA collection, leading the agency to eventually promise a cessation of falseimmunization campaigns.

CIA Labs, a 2020 initiative overseen by Donald Trumps CIA director, Gina Haspel infamous for running a torture laboratory in Thailand follows a model similar to In-Q-Tels. The program created a research network to incubate top talent and technology for use across U.S. defense agencies, while simultaneously allowing participating CIA officers to personally profit off their research and patents.

In-Q-Tel board members are allowed to sit on the boards of companies in which the firm invests, raising ethics concerns over howthe non-profit selects companies to back with government dollars. A 2016 Wall Street Journal investigation found that almost half of In-Q-Tel board members were connected to the companies where it had invested.

The size of In-Q-Tels stake in Colossal wont be known until the nonprofit releases its financial statements next year, but the investment may provide a boon on reputation alone: In-Q-Tel has claimed that every dollar it invests in a business attracts 15 more from other investors.

Colossals co-founders, Lamm and Church, represent the ventures business and science minds, respectively. Lamm, a self-proclaimed serial technology entrepreneur, founded his first company as a senior in college, then pivoted to mobile apps and artificial intelligence before helping to start Colossal.

Church a Harvard geneticist, genome-based dating app visionary, and former Jeffrey Epstein funding recipient has proposed the revival of extinct species before. Speaking to Der Spiegel in 2013, Church suggested the resurrection of the Neanderthal an idea met with controversy because it would require technology capable of human cloning.

We can clone all kinds of mammals, so its very likely that we could clone a human, Church said. Why shouldnt we be able to do so? When the interviewer reminded him of a ban on human cloning, Church said, And laws can change, by the way.

Even when the methods used for de-extinction are legal, many scientists are skeptical of its promise. In a 2017 paper for Nature Ecology & Evolution, a group of biologists from Canada, Australia, and New Zealand found that [s]pending limited resources on de-extinction could lead to net biodiversity loss.

De-extinction is a fairytale science, Jeremy Austin, a University of Adelaide professor and director of the Australian Center for Ancient DNA,toldthe Sydney Morning Herald over the summer, when Colossal pledged to sink $10 million into the University of Melbourne for its Tasmanian tiger project. Its pretty clear to people like me that thylacine or mammoth de-extinction is more about media attention for the scientists and less about doing serious science.

Critics who say de-extinction of genes to create proxy species is impossible are critics who are simply not fully informed and do not know the science. We have been clear from day one that on the path to de-extinction we will be developing technologies which we hope to be beneficial to both human healthcare as well as conservation, Lamm wrote to The Intercept. We will conitnue [sic] to share these technologies we develop with the world.

It remains to be seen if Colossal, with In-Q-Tels backing, can make good on its promises. And its unclear what, exactly, the intelligence world might gain from the use of CRISPR. But perhaps the CIA shares the companys altruistic, if vague, motives: To advance the economies of biology and healing through genetics. To make humanity more human. And to reawaken the lost wilds of Earth. So we, and our planet, can breathe easier.

Update: September 28, 2022, 1:00 p.m. ETThis story has been updated with a statement from Colossal co-founder Ben Lamm.

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CIA Just Invested In Woolly Mammoth Resurrection Tech - The Intercept

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Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis…

♫ Thursday, September 29th, 2022

Impacting more than 12 million people globally, HDV is the most aggressive form of viral hepatitis

Novel combination strategy designed toreduce HDV viremia and block viral entry

SAN FRANCISCO, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus (HDV), which occurs as a simultaneous co-infection or super-infection alongside hepatitis B virus (HBV). HDV infection, the most aggressive form of viral hepatitis, increases the risk of poor outcomes, including liver cancer and death, compared with HBV alone.

VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) that diminishes the level of all HBV proteins in vitro, including hepatitis B surface antigen, a protein necessary to create infectious HDV virions. VIR-3434 is an investigational hepatitis B surface antigen targeting monoclonal antibody designed to remove both HBV and HDV virions from the blood and block the entry of these viruses into liver cells. VIR-2218 and VIR-3434 are currently being evaluated for the treatment of HBV in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial. Previously reported results from Part A of the MARCH trial demonstrated that the combination of VIR-3434 and VIR-2218 resulted in an approximate 3 log decline in hepatitis B surface antigen (HBsAg).

Globally, more than 12 million people are living with HDV, and with no approved therapies available in the United States, there is an urgent need for the development of novel treatment strategies that will improve outcomes for patients, said Carey Hwang, M.D., Ph.D., Virs senior vice president, clinical research, head of chronic infection. Recent research suggests that reducing HDV viremia, by preventing virion formation as well as facilitating virion removal, in conjunction with blocking HDV virion entry into liver cells could be effective in suppressing chronic HDV infection. The initiation of SOLSTICE, our first clinical trial in HDV, is an important milestone as we advance our broad therapeutic portfolio for viral hepatitis, which also includes the pursuit of a functional cure for chronic HBV infection.

Design of the Phase 2 SOLSTICE TrialThe multi-center, open-label Phase 2 SOLSTICE trial is designed to evaluate the safety, tolerability, and efficacy of VIR-2218 and VIR-3434 in adult patients (age 18 to 69) with chronic HDV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants will receive multiple doses of VIR-2218 and VIR-3434 as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a 2log10 decrease in HDV RNA compared to baseline, or HDV RNA less than the limit of quantification and normalization of alanine transaminase (ALT) at Week 24, as well as the proportion of participants with treatment-emergent adverse events and serious adverse events. Vir expects initial data from the SOLSTICE trial in 2023.

About Chronic Hepatitis DChronic hepatitis D virus (HDV) infection occurs as a simultaneous co-infection or super-infection with hepatitis B virus (HBV). An estimated 12 million patients globally are infected with HDV, representing approximately 5% of those infected with HBV. HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression toward hepatocellular carcinoma and liver-related death.

About Chronic Hepatitis BChronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with HBV and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and poor tolerability. Vir is working to achieve a functional cure for the millions of people with HBV around the world through its broad and differentiated portfolio.

About VIR-2218VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the Companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of HBV and HDV viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencors Xtend and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV and HDV in infected patients, as well as to have an extended half-life.

About Vir BiotechnologyVir Biotechnologyis a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, expect, anticipate, promising and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of VIR-2218 and VIR-3434 in combination to treat chronic HDV and HBV infection; the potential benefits of VIR-2218 and VIR-3434; Virs plans and expectations for its HDV and HBV portfolios; the initial results of the MARCH trial; the timing for and design of the Phase 2 SOLSTICE trial; the treatment of HDV and HBV; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks that Vir may not fully enroll the Phase 2 SOLSTICE trial or it will take longer than expected; unexpected safety or efficacy data or results observed during the Phase 2 SOLSTICE trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; successful development and/or commercialization of alternative product candidates by Virs competitors; changes in expected or existing competition; delays in or disruptions to Virs business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Virs filings with the U.S. Securities and Exchange Commission, including the section titled Risk Factors contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology Announces First Patient Dosed in the Phase 2 SOLSTICE Trial Evaluating VIR-2218 and VIR-3434 for the Treatment of Chronic Hepatitis...

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