VetStem Biopharma, Inc., Announces the Opening of its GMP Cell Therapy Manufacturing Facility
VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant at its headquarters laboratory in Poway, California
VetStem Biopharma, Inc., announced the opening of its GMP cell therapy manufacturing facility at its headquarters laboratory in Poway, California. Based upon 12 years of knowledge gained by following GTP laboratory guidelines and utilizing the experience of both in-house personnel and consultants, VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant. This clean room facility has already produced three registration batches of stem cell product and those batches have been officially released for use in pivotal FDA studies of safety and efficacy.
Carolyn Wrightson, Ph.D., VP of Operations, stated, “This facility is the culmination of six years of planning and research, supported by over 12 years of commercial stem cell laboratory operations by VetStem’s experienced cell therapy team. We believe this is the first dedicated veterinary-specific cell therapy facility in the United States. It will provide all the stem cell products for use in VetStem FDA product development programs.” The facility operates under FDA GMP guidelines and is designed to produce commercial products, once approved by the FDA.
“Quality is a critical element necessary to bring stem cell therapy into mainstream veterinary practice. VetStem has been committed to quality since its founding and has worked directly with the FDA Center for Veterinary Medicine since 2003 to assure our products and services adhere to the strictest guidelines for safety and efficacy,” said Bob Harman, DVM, MPVM, CEO of VetStem. “VetStem offers tours of this unique facility via large viewing windows in an exterior corridor and veterinarians are amazed at the high tech approach to veterinary cell therapy including the specialized approach to donor selection, disease screening, clean room cell culture and final packaging of the product in specialized cell product vials.”
“Stem cell therapy is a truly novel and natural approach to treatment of acute and chronic diseases in animals that have few or less efficacious therapeutic options. Using donor derived allogeneic stem cells provides cell therapy in a “ready to use” format without the need for tissue collection, or processing thus expanding the availability to more animals. VetStem is dedicated to providing affordable stem cell therapy for diseases of dogs, cats and horses, especially in areas of unmet needs,” according to Harman.