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CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs

Oct 11th, 2019

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As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.

Offering some of the lessons learned from CGT reviews to date at a session on facility design at the CASSS June 2019 CGT product symposium held in Bethesda, Maryland, CBER Division of Manufacturing and Product Quality (DMPQ) Consumer Safety Officer Lily Koo warned against “over-reliance on procedural controls.”

Instead, she stressed, firms considering designing their own facility should start early in Phase 1/2 to think about the engineering requirements.

Koo recognized that since CGT development is often taking place on an accelerated pace and in a contract manufacturing or university setting, CGT sponsors may not start “thinking about commercial facilities until much later.” Instead, she stressed, “you should think about it earlier.”

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