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ATMP Potency Assay Strategies: Adding Value to Your Asset and Avoiding Delays in Development

Potency assays are used to monitor the quality, consistency and stability of medicinal products and are crucial to chemistry, manufacturing and control (CMC), as well as clinical development. This white paper discusses the value of planning potency assays early in the clinical development process, explains some of the barriers to potency assay development and regulatory acceptance, and provides some top tips on how to overcome potential hurdles.