Learning from pediatric CAR-T development: insights from manufacturing unique patient doses

Abstract

Chris Brown is the Director of GMP Manufacturing within the Therapeutic Cell Production Core, Seattle Children’s Therapeutics’ GMP cell manufacturing facility. He leads the facility’s manufacturing/process development team and played a key role in initial design, stand-up, and ongoing development of the TCPC facilities, team, and manufacturing methodologies. He has more than 20 years’ experience in the manufacturing of cellular products for Phase 1 and 2 clinical trials, with a focus in translating cutting-edge research into first-in-human cellular therapeutics. He joined Seattle Children’s Research Institute from the Fred Hutchinson Cancer Research Center in 2010, where he led the manufacturing team within the Cellular Production Facility cleanroom. He holds a BA in Biology from Carleton College in Northfield, Minnesota.Sean Werner is the Chief Technology Officer – Cell Processing at BioLife Solutions, a leading provider of bioproduction tools and services to the cell and gene therapy and broader biopharma markets. BioLife acquired Sexton Biotechnologies in 2021 where Sean was President of the company known for providing processing and handling solutions for the CGT industry. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Sean has previous experience filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.