WEBINAR: From Boutique to Global: Chimeric Antigen Receptor T Cells as a Model for Clinical Development and Commercialization


Bruce Levine, Ph.D.
University of Pennsylvania, USA | Founding Director of CVPF


Since the 1990’s, we have conducted clinical trials of gene modified T cells. Gene editing has created T cell resistant to HIV infection. Chimeric antigen receptor (CAR) T cells targeting CD19 on B cells leukemias and lymphomas have induced durable complete responses in patients who are relapsed or refractory to all other available treatments. This synthetic biology technology hs now undergone global multi-center clinical trials and recently received FDA, EMEA, Canada, Switzerland, and Australia approvals (KymriahTM, Novartis) in relapsed/refractory acute lymphoid leukemia in children and young adults as well as in diffuse largeB cell lymphoma. Translation of these technologies from research bench to clinical application requires integrated scientific, engineering, and regulatory expertise. New designs for genetically engineered T cells include switches and potency enhancements that will be required for targeting solid tumors. The road forward for wide patient access to these uniquely personal cellular therapies depends not only on scientific progress in targeting, gene modification and cellular manipulation, but also on meeting automation, engineering, and health policy changes.

Learn more about Sartorius solutions for CAR-T Discovery & Development at www.sartorius.com/car-t-research.

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