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ISPE Guide: ATMPs – Autologous Cell Therapy PDF
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Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2021
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This Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.
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