Performance Cell Manufacturing (PCM), a contract development manufacturing organization division of VetStem Biopharma, announced that the facility they utilize for cGMP cell production is approved by the California Department of Public Health, Food and Drug Branch for manufacturing. Performance Cell Manufacturing is currently contracted with multiple companies to develop and perform cell-based manufacturing for research development and for use in clinical trials.
PCM 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. In order to secure this, our facility underwent an intensive inspection by three inspectors from the California DPH and passed the inspection first time through. I am proud of the high standards set by Chief Operating Officer, Dr. Carolyn Wrightson and Senior Quality Manager, Scott Caton along with their dedicated staff.”
PCM was born from over 15 years of experience with cGMP compliant cell therapy product development and manufacturing. The company provides cell therapy development and cGMP contract manufacturing for companies conducting FDA phase 1 and phase 2 clinical trials.