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White Papers / Tech Papers

Overcoming Challenges in Potency Assays for Cell and Gene Therapy Development 

Potency assays are central to proving a therapy activity and safety.

Released By Solvias

Potency assays are central to proving a therapy activity and safety, yet for advanced therapies like cell and gene therapies they often require complex, bespoke solutions. Manufacturers face major challenges—from limited sample volume to intricate mechanisms of action—and regulators frequently cite potency issues as barriers to approval. This overview reveals why nearly half of ATMP submissions encounter potency-related setbacks and what it takes to overcome them.

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