Issue Date: December 27, 2023
Issued by: Center for Biologics Evaluation and Research
Topic(s): Gene Therapy
Status: Draft
Potency Assurance for Cellular and Gene Therapy Products
On December 28, 2023, FDA announced the availability of the draft guidance, Potency Assurance for Cellular and Gene Therapy Products. For a high-level overview of this guidance document, please view this recorded webinar featuring Dr. Matthew Klinker, Cell Therapy Branch 2 Chief, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER. This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. 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.
Download the Guidance Document
