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The Netherlands Area Biotech Discussion Group

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March 16, 2022

Contact: Julie Harris
Phone: 510-428-0740

Regulatory Aspects of Manufacturing and Control of CAR-T Cells, Game-changing Autologous Immunotherapy Products | 16 March 2022 16:00-17:30 Central European Time

Marcel Hoefnagel, Senior Assessor Biopharmaceuticals, Medicines Evaluation Board, The Netherlands

CAR-T cells are autologous T-cells engineered with a Chimeric Antigen Receptor (CAR) to recognize a specific target on patient tumor cells, which are killed by the immune response.  Immunotherapy using CAR-T cells has proven to be a game changer in treatment of some types of leukemia and currently explored for many more tumor types. CAR-T cell manufacturing starts with autologous T-cells. These T-cells are transduced to express the CAR e.g. using a viral vector or gene editing tools. The transduced cells are expanded and infused back into the patient. Although these are complex cell products they can be manufactured in a rather standardized process. The presentation will cover the Mode of action of CAR-T cells as well as the regulatory requirements for the manufacturing steps and their control.

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