FDA invites stakeholder input on draft potency assurance guidance

By Dr Nicola Davies

In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1

The major aim of the guidance is to ensure drug developers can create science- and risk-based strategies to certify that every batch of product released has the same potency; that is, the specific capability required to achieve the intended therapeutic effect. These strategies are expected to be based on the principles of quality risk management, including manufacturing process design, manufacturing process control, material control, in-process testing, and end-product testing.2,3 This ensures the potency assurance strategy covers each stage of clinical development.