Potency Assurance for Human Cellular and Gene Therapies Addressed in Draft Guidance

The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT).

The strategies, outlined in the 27-page guidance, “Potency Assurance for Cellular and Gene Therapy Products,” are multipronged approaches that reduce the risk of potency variability throughout the entire manufacturing process, from process design to material control, in-process testing and assays to measure potency before a lot is released for sale.

“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,” the guidance notes. Public comment on the draft is open through March 27, 2024.

Read the draft guidance here.

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