Cell/Gene Product Potency Assurance

FDA has published a draft guidance, Potency Assurance for Cellular and Gene Therapy Products, with recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy product. The document says 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 says that when it is finalized, the draft will supersede a 1/2011 guidance.

The draft contains an Introduction, Background, Regulatory Framework, Developing a Potency Assurance Strategy, and Potency Assays and Acceptance Criteria.