The US Food and Drug Administration issued final guidance on Monday for manufacturers of cellular and gene therapy products, setting out a science and risk based potency assurance strategy that covers raw material variability, testing during manufacturing and laboratory tests confirming each batch is biologically active as intended. The guidance, titled Potency Assurance for Cellular and Gene Therapy Products, replaces the agency’s 2011 potency testing guidance and applies from early phase investigational new drug submissions through biologics license approval and post market verification, with added detail for short shelf life products, viral vector therapies and patient specific therapies. Karim Mikhail, director of the Center for Biologics Evaluation and Research, said patients receiving these therapies are often battling serious or life threatening conditions and deserve assurance the product administered will perform as intended, and the agency will host a webinar on December 10, 2026 to explain the guidance.
FDA issues final potency guidance for cell and gene therapies
The FDA issued final guidance on November 2 requiring makers of cellular and gene therapy products to build a potency assurance strategy into every stage of a product's life, replacing its 2011 potency testing guidance.
Why it matters: Potency is the test that each batch of a cell or gene therapy actually does what it is meant to do, and a single final standard, applied from early trials through post market monitoring, gives manufacturers a predictable quality bar for products that are often made for one patient at a time.
Data as of FDA news release of November 2, 2026, read in full in this run. Developing item.
Sources
- FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality - US Food and Drug Administration - 2026-11-02