VetStem Biopharma Begins Contract Human Stem Cell Manufacturing in San Diego
VetStem Biopharma has 15 years of stem cell manufacturing and clinical use experience. VetStem has formally begun GMP manufacturing of stem cells for human biopharma clinical trials as a contract manufacturer.
VetStem Biopharma has long been a leader in veterinary stem cell manufacturing with clinical, regulatory and manufacturing experience. In August 2018, VetStem signed its first contract manufacturing agreement to manufacture cells for human clinical trials. With one of the first GMP cell manufacturing facilities in California, VetStem is uniquely suited to assist biopharma companies with the regulatory and manufacturing of stem cells for use in preclinical studies and for Phase I and Phase II FDA human studies. In addition, VetStem is filing several human stem cell INDs using its veterinary data and experience to jumpstart its human stem cell development program.
VetStem has clinical data on over 17,000 veterinary stem cell treatments spanning 31 different species and has GCP, GTP, GMP, and GLP experience. As announced in 2017, VetStem completed the GMP cell therapy manufacturing facility at its headquarters laboratory in Poway, California. Based upon 12 years of GTP laboratory operations, VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant. This clean room facility has already produced engineering and full product 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., Chief Operating Officer, 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.” According to Bob Harman, DVM, MPVM, CEO of VetStem, “Quality is the critical element necessary to bring stem cell therapy into mainstream medicine. VetStem has been committed to quality since its founding and has worked directly with the FDA, both veterinary and human divisions, to assure our facilities and products adhere to the strictest guidelines for safety and efficacy. We offer tours of the facility and are happy to provide proposals for contract manufacturing for stem cell products. VetStem has FDA master files that cover facilities and operations as well as key elements of IND submissions like stem cell vial validation and manufacturing methods for easy IND reference.”
FDA cGMP regulations apply equally to veterinary and human products, so it was a natural progression to offer VetStem’s facility and technical expertise to companies seeking to conduct their first human trials. VetStem’s patient registry large animal data is also potentially available to license for assistance with the human FDA requirement for animal safety data before companies can enter human clinical trials. Dr. Harman stated, “We believe that we can really jumpstart cell manufacturing for new companies and potentially save years and millions of dollars of investment by utilizing our existing facilities and hundreds of standard operating procedures.”
Prior to VetStem, Dr. Harman founded and operated the largest west coast contract preclinical animal laboratory conducting FDA submission safety and efficacy studies for veterinary and human biotech products. VetStem also has direct access to human clinical trial and IND consultants to assist companies in their regulatory filings and protocol designs.
Contact VetStem for more information or if you are interested in contract manufacturing for stem cell products.