Points to Consider No. 14: Manufacturing of ATMPs – Facility Design (Part 1)

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This Points to Consider document considers the facility, utilities, and process equipment designs necessary to support the manufacture and testing of ATMP therapies (autologous and allogeneic). Ideally, the design considerations should be weighed upfront to ensure the process meets the respective requirements. This document is organized into topics and various subtopics that address the questions raised about ATMP manufacture. Each question first presents an overall recommendation, which may be followed by a rationale for the recommendation and/or appropriate references for further reading.