header logo image


Page 57«..1020..56575859

Archive for the ‘Regenerative Medicine’ Category

Stem Cell Based Therapies for Blindness: David Hinton – CIRM Science Writer’s Seminar – Video

Friday, November 18th, 2011

(Part 6 of 9) David Hinton, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Hinton has a CIRM grant to study the therapeutic potential of retinal pigment epithelial cell lines derived from human embryonic stem cells for retinal degeneration. Hinton is a professor of pathology, neurosurgery, and ophthalmology at the Keck School of Medicine at the University of Southern California.

See the article here:
Stem Cell Based Therapies for Blindness: David Hinton - CIRM Science Writer's Seminar - Video

Read More...

Coast To Coast AM – 15.11.2011 – 1/4 – Regenerative Medicine/Dulce Base – Video

Thursday, November 17th, 2011

MP3 http://www.4shared.com Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr.

More:
Coast To Coast AM - 15.11.2011 - 1/4 - Regenerative Medicine/Dulce Base - Video

Read More...

Coast To Coast AM – 15.11.2011 – 4/4 – Regenerative Medicine/Dulce Base – Video

Thursday, November 17th, 2011

Guests: Anthony F. Sanchez, Christian Wilde Regenerative Medicine: In the first half of Tuesday's show, researcher Christian Wilde talked about the emerging field of regenerative medicine, and how scientists are actually building replacement body parts with stem cells. He announced that Dr

Continued here:
Coast To Coast AM - 15.11.2011 - 4/4 - Regenerative Medicine/Dulce Base - Video

Read More...

Commercializing Cell-based Regenerative Medicines

Sunday, November 13th, 2011

Tweet 

When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Commercializing Cell-based Regenerative Medicines

Sunday, November 13th, 2011

Tweet 

When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

Read More...

Opening Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine – Video

Sunday, October 23rd, 2011

Program Chair: Kelvin Lam, PhD, Harvard University, USA From the SBS Symposium Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine. Held in Boston, MA, USA - September 2-3, 2009.

Read more from the original source:
Opening Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine - Video

Read More...

Regenerative Medicine: Pathways to Cure – Version 2.0 – Video

Friday, October 21st, 2011

The Alliance for Medical Research is pleased to present a new video explaining the benefits of Stem Cell Research.

Excerpt from:
Regenerative Medicine: Pathways to Cure - Version 2.0 - Video

Read More...

You and Your Heath TV Show – Orthopedic Regenerative Medicine Part 1 – Video

Friday, October 21st, 2011

Host Dr. David Bertone, PT, DPT, OCS inteviews Dr Edward Magaziner, MD on the latest procedures used in the field of Orthopedic Regenerative Medicine including prolotherapy, platelet-rich plasma and stem cell transplants for chronic pain, tendonitis and arthritis

Read the original here:
You and Your Heath TV Show - Orthopedic Regenerative Medicine Part 1 - Video

Read More...

TEDxPhoenix – Jane Maienschein – Stem Cells, Regenerative Medicine and Us – Video

Friday, October 21st, 2011

TEDxPhoenix 2009 presents Dr. Jane Maienschein, Professor of Biology, School of Life Sciences, Arizona State University

More here:
TEDxPhoenix - Jane Maienschein - Stem Cells, Regenerative Medicine and Us - Video

Read More...

Retroviruses, Reproduction, and Regenerative Medicine: The Influence of Federal Funding – Video

Friday, October 21st, 2011

Ann Anderson Kiessling, Ph.D. (Harvard Medical School and the Bedford Stem Cell Research Foundation, Bedford Massachusetts) was introduced by Dorrie Fontaine, Ph.D., RN, FAAN (Sadie Health Cabaniss Professor and Dean, School of Nursing, University of Virginia) who also described a newly established award by the School of Nursing, called the "Alumni Achievement Award," which is awarded to a nursing graduate who has contributed beyond the field of nursing.

Read the rest here:
Retroviruses, Reproduction, and Regenerative Medicine: The Influence of Federal Funding - Video

Read More...

McEwen Centre for Regenerative Medicine – Video

Thursday, October 20th, 2011

The McEwen Centre for Regenerative Medicine was established at University Health Network in 2003 with a generous donation from Rob and Cheryl McEwen, which they matched in 2006 with a second donation. The McEwen Centres vision is to be a world-renowned centre for stem cell biology and regenerative medicine. To achieve this ambitious goal, the team of McEwen Investigators is working together to accelerate the development of more effective treatments for conditions such as heart disease, diabetes, respiratory disease and spinal cord injury

View post:
McEwen Centre for Regenerative Medicine - Video

Read More...

A New Era in Regenerative Medicine – Video

Thursday, October 20th, 2011

"Our discovery of the 'pure' human blood stem cell could open up a new era in regenerative medicine," says principal investigator John Dick, who holds a Canada Research Chair in Stem Cell Biology and is a Senior Scientist at the McEwen Centre for Regenerative Medicine and the Ontario Cancer Institute, University Health Network. Release available here: http://www.uhn.ca

Read the original:
A New Era in Regenerative Medicine - Video

Read More...

What is Regenerative Medicine? | Los Angeles | Hollywood | Beverly Hills – Video

Wednesday, October 19th, 2011

metromd.net What is Regenerative Medicine? An overview of Regenerative Medicine, Stem Cells and HGH hormone replacement by Alex Martin, MD

Read more here:
What is Regenerative Medicine? | Los Angeles | Hollywood | Beverly Hills - Video

Read More...

Hearing Loss Research: CBR Exclusive! Stem Cells Explored as Cure for Hearing Loss – Video

Wednesday, October 19th, 2011

Learn how newborn stem cells are being researched as treatment for patients with hearing loss. An innovative study held at Children's Memorial Hermann Hospital in Houston will be evaluating the effects of a child's own cord blood as treatment for acquired hearing loss. Only CBR offers your family exclusive access to several groundbreaking clinical trials such as this one.

Excerpt from:
Hearing Loss Research: CBR Exclusive! Stem Cells Explored as Cure for Hearing Loss - Video

Read More...

An amazing story of stem cells, regenerative medicine and healing power: – Video

Wednesday, October 19th, 2011

Huge gains in tissue regeneration are happening now. Adult stem cells are used in these groundbreaking procedures and are the foundation for many more in trials today

Visit link:
An amazing story of stem cells, regenerative medicine and healing power: - Video

Read More...

Regenerative Medicine and Applications of Stem Cell Research – Video

Tuesday, October 18th, 2011

(June 1, 2010) Renee Reijo Pera, Ph.D., and Professor Michael Longaker discuss the future of regenerative medicine and the promise that stem cell research holds for this field. During the final quarter of the Stanford Mini Med School, some of the most timely and important topics in contemporary medicine and the biosciences are addressed

Read this article:
Regenerative Medicine and Applications of Stem Cell Research - Video

Read More...

The Future of Stem Cells and Regenerative Medicine – Video

Tuesday, October 18th, 2011

Excerpt from:
The Future of Stem Cells and Regenerative Medicine - Video

Read More...

"You and Your Health" TV Show – Orthopedic Regenerative Medicine – Video

Tuesday, October 18th, 2011

Host Dr. David Bertone, PT, DPT, OCS inteviews Dr Edward Magaziner, MD on the latest procedures used in the field of Orthopedic Regenerative Medicine including prolotherapy, platelet-rich plasma and stem cell transplants for chronic pain, tendonitis and arthritis. This showed is part of the You and Your Health series aired on Old Bridge TV.

Read more from the original source:
"You and Your Health" TV Show - Orthopedic Regenerative Medicine - Video

Read More...

Closing Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine – Video

Tuesday, October 18th, 2011

Robert Ames, PhD, GlaxoSmithKline, USA; From the SBS Symposium Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine. Held in Boston, MA, USA - September 2-3, 2009.

Excerpt from:
Closing Remarks, Screening Stem Cells 2009: From Reprogramming to Regenerative Medicine - Video

Read More...

Mayo Clinic Regenerative Medicine Consult Service – Video

Sunday, October 16th, 2011

Learn more about Mayo Clinic's new Regenerative Medicine Consult service from a Mayo Clinic expert on stem cell therapies.

View post:

Mayo Clinic Regenerative Medicine Consult Service - Video

Read More...

Page 57«..1020..56575859


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