Critical considerations & common mistakes in early-phase CMC development
Cell & Gene Therapy Insights 2019; 5(1), 35–41
10.18609/cgti.2019.005
DR JASON CARSTENS has over 20 years of process development, GMP manufacturing, and CMC project management experience in the biotech industry. Dr Carstens is currently the Chief Operating Officer and a Principal Consultant at Pluristyx, Inc., an advanced therapy tools and service company that he co-founded which serves customers in the rapidly growing field of regenerative medicine and cellular therapies. Pluristyx has a line of pluripotent stem cell-based products and also offers contract development, manufacturing, and consulting services. Prior to Pluristyx, Dr Carstens was VP of Manufacturing and Development at Nohla Therapeutics, a Seattle-based cell therapy company developing clinical products from hematopoietic stem cells. Dr Carstens also spent 5 years as the Director of Cell Therapy Process Development and Manufacturing at the Fred Hutchinson Cancer Research Center in Seattle. While at Fred Hutch, he worked on a variety of autologous and allogenic cell and gene therapy products including CAR T cells, TIL, antigen specific T cells, hematopoietic stem cells, and B cells for use in human clinical trials. Dr Carstens also spent 13 years at CMC Biologics, a contract development and manufacturing organization, where he was responsible for cell line and cell culture process development supporting manufacture, transfer, and scale-up of more than 50 unique recombinant proteins, antibodies and biosimilars. Dr Carstens also has an appointment at the University of Washington as an Affiliate Associate Professor. He earned his PhD in Chemical Engineering from the University of California at Berkeley and a BS in Chemical Engineering from the University of Washington.