Full Title: FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing. Case studies will be presented and discussed. Presented by Lily Koo, CBER at Food and Drug Administration Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for viral vaccines, blood fractionation products, cell and gene therapy products, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked two and half years at the Center for Device and Radiological Health and ten years at the National Institutes of Health. Lily received her B.S. in bioengineering from the University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.

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BioPharma Asia Magazine
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