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"PFAS in Cell & Gene Therapy: E&L Strategy Decision Framework"

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Cell and gene therapy (C>) products offer groundbreaking treatment options for conditions once considered untreatable. However, their specialized manufacturing processes pose complex challenges for extractables and leachables (E&L) testing. Single-use fluoropolymer components used during production may contain PFAS (“forever chemicals”) which can leach into the final product. This resource outlines a regulatory-endorsed framework for conducting E&L testing in C>, grounded in real-world case studies and FDA-reviewed data. Download now to explore the role of PFAS in C> processing, key E&L testing challenges, practical testing parameters, and more.

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