This month we underwent an intensive inspection by three inspectors from the California DPH and we passed the inspection first time through.
POWAY, Calif. (PRWEB) June 11, 2019
Veterinary Regenerative Medicine company, VetStem Biopharma, parent company of Personalized Stem Cells Inc. (PSC), has announced that their GMP facility for cell production is now approved by the California Department of Public Health, Food and Drug Branch for manufacturing. This is an important milestone for VetStem as it expands into contract cell manufacturing services. VetStem is currently contracted with multiple companies to develop and perform cell-based manufacturing (to include stem cells) for use in human clinical trials. PSC will be the first VetStem client to launch human stem cell clinical trials planned for late 2019.
VetStem has been providing stem cell processing services for veterinarians for over 15 years and is now providing Contract Manufacturing Services to companies engaged in human clinical trials. VetStem founder and CEO, Dr. Bob Harman stated, “In order to legally manufacture human stem cell products for clinical trials, a laboratory must comply with FDA cGMP regulations and must also have a California Department of Public Health manufacturing license. This month we underwent an intensive inspection by three inspectors from the California DPH and we passed the inspection first time through. I am proud of the high standards set at VetStem by Chief Operating Officer, Dr. Carolyn Wrightson and Senior Quality Manager, Scott Caton along with their dedicated staff. We will be producing human cell therapy products for multiple companies beginning this summer.”
PSC’s first clinical trials are planned to begin in late 2019 with an initial focus on osteoarthritis and orthopedic conditions. PSC has also licensed VetStem’s extensive patent portfolio for certain technologies and stem cell applications in the United States. The inspection and approval by the California Department of Public Health is one of the final approvals needed in order to initiate patient specific stem cell manufacturing.
About Personalized Stem Cells, Inc.
Personalized Stem Cells was formed in 2018 to advance and legitimize human regenerative medicine. This privately held biopharmaceutical enterprise, based near San Diego (California), offers qualified physicians who enroll, FDA compliant autologous stem cells (from the patient’s own fat tissue) for use in FDA approved clinical trials. PSC is driving development and adoption of stem cell therapy and regenerative medicine within the FDA-IND process by providing quality manufactured, safety tested cells and well-defined clinical trials. PSC has licensed a portfolio of over 70 issued patents in the field of regenerative medicine.
About VetStem Biopharma, Inc.
VetStem Biopharma is a veterinarian-lead Company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego, California, currently offers veterinarians an autologous stem cell processing service (from patients’ own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 15 years and 17,000 treatments by veterinarians for joint, tendon or ligament issues, VetStem has made regenerative medicine applications a therapeutic reality. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a large portfolio of issued patents in the field of regenerative medicine.