Issue Date: November 2, 2026
Issued by: Center for Biologics Evaluation and Research,Office of Therapeutic Products
Topic(s): Gene Therapy
Status: Final
Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products
This 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. We, the FDA, are issuing this guidance to assist you (manufacturers, applicants, and other stakeholders) in developing approaches for assuring the potency of CGT products. A potency assurance strategy is a multifaceted and flexible 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. This final guidance supersedes the document entitled “Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products,” dated January 2011.
Download the Guidance Document
