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The supply chain for cellular therapies has a unique aspect of starting with a patient undergoing a procedure and ending with another procedure. This session will provide case studies and best practices around the demarcation of clinical practice with GMP for cellular therapies, orchestration of patient procedures, defining chain of identify information, and clarifying the differences between chain of identity and lot genealogy. These are major issues that are unique to the cellular ATMP supply chain.
Our presentations will address these aspects by providing both a basis level of understanding of the topics and best practices. These points will be supported with real life experiences. By presenting the why (basis understanding), the how (best practices), and the what (experiences), we aim to provide attendee with the tools to navigate these unique aspects of the supply chain for ATMPs.
Session Leader(s):
Erich
H. Bozenhardt,
Associate Director Process Engineering, Regenerative Medicine,
United Therapeutics