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EU24CEMAR1/SES114 - Maintaining Control in Point of Care Aseptic Processing for ATMPs


‐ Mar 13, 2024 3:00pm

Maintaining Control in Point of Care Aseptic Processing for ATMPs|Typically aseptic processes are conducted in centralized facilties manufacturing large quantities of units or specialty pharmacies formulate a drug for a single patient. For some ATMP products there are technical limits that require final aseptic manipulation before administration (e.g. cell washing, reconstitution) that are considered part of the process. Also, the transport to/from the patient for autologous therapies increases the time to treat for critically ill patients and increases the cost of the therapy. This presentation will introduce the drivers for ATMP manufacturing at point of care and the regulatory frameworks that exist. Then the session will turn to a panel discussion an how different companies are approaching implementation of aseptic ATMP manufacturing at point of care.