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Program Lead, Cell and Gene Therapy - Driving development of transformative therapies for cancer and rare diseases

Potency Assurance for Cellular and Gene Therapy Products "A potency assurance strategy is a multifaceted approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect." #FDA #celltherapy #cellandgenetherapy #manufacturing

Potency Assurance for Cellular and Gene Therapy Products

Potency Assurance for Cellular and Gene Therapy Products

fda.gov

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