Building confidence in cell and gene therapy: USP’s role in an evolving therapeutic frontier

“Through expert panels, committees, and direct outreach, we rely on the community to tell us where resources and harmonization are needed most.”

Analytical variability and limited harmonization of critical quality attributes continue to constrain the scalable, reproducible development of cell and gene therapies. Divergent methods for parameters such as AAV empty-to-full capsid ratios, genome titers, and potency increase development burden and complicate regulatory alignment across highly customized platforms. The United States Pharmacopeia (USP) is advancing modality-focused reference standards, raw material controls, and fit-for-purpose analytical guidance to improve comparability and reduce uncertainty. Establishing shared, science-based benchmarks will be central to strengthening quality frameworks and sustaining confidence as these advanced therapies mature.

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