Adopting quality controls based on a combination of FDA’s human current cGMPs and cGTP would represent an appropriate quality system to mitigate the risk of contamination and infection; and ensure the production of a safe product.
Poway, CA (PRWEB) October 10, 2013
Vet-Stem, Inc. proudly announces the publication of the most recent Food and Drug Law Institute Primer covering Food and Drug Administration’s Regulation of Veterinary Drug Products, which includes a chapter authored by Vet-Stem’s Founder and CEO, Robert J. Harman, DVM, MVPM. Dr. Harman worked closely with Karl M. Nobert JD, MBA to compose the chapter on FDA’s Possible Regulation of Veterinary Stem Cell Therapy.
Some of the main points from this chapter are that commercialization has thus far utilized autologous stem cells and allogeneic use of all sources of stem cells is still in the research phase, and currently no products on the market in the United States have Food and Drug Administration (FDA) approval. Also, Dr. Harman suggests, “Adopting quality controls based on a combination of FDA’s human current Good Manufacturing Practices (cGMPs) and Good Tissue Practice (cGTP) would represent an appropriate quality system to mitigate the risk of contamination and infection; and ensure the production of a safe product.”
Dr. Harman’s experience in authoring more than 500 contract study reports for animal health companies throughout the world and for submission to the U.S. Food and Drug Administration and U.S. Department of Agriculture in support of the development of new animal and human health products as well as his expertise in stem cells and Regenerative Veterinary Medicine made him a valuable resource in discussing veterinary regenerative medicine, the commercialization of veterinary stem cell therapy, and the FDA’s regulation of veterinary stem cell therapy. Dr. Harman founded Vet-Stem, Inc., the leading Regenerative Veterinary Medicine Company. Vet-Stem uses a process that utilizes autologous adult stem cells from adipose tissue to help reduce pain, inflammation, and to stimulate the regeneration of damaged tissues. Over the last decade Vet-Stem has processed the tissue of 10,000 animals to provide treatment with their own stem cells.
About Vet-Stem, Inc.
Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.’s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.