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2022 ISPE Annual Meeting & Expo

SES108b - Industry Perspective: Development of Autologous Cell Therapy Aseptic Process Simulations for CAR-T Cell Therapy Products

Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


This presentation will focus on the quality considerations associated with designing an APS for autologous cell therapies. For CAR-T cell therapy products, aseptic process simulations can be complex and have unique product specific processing steps which require special considerations for validation. 

This presentation will provide specific case studies and scenarios for study design and development for cell therapy manufacturing based on industry best practices and regulations. 

Case studies will be provided with key challenges/risks reviewed.


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