This report provides a practical and strategic overview of potency in cell therapy development, addressing key scientific, regulatory, and translational considerations associated with potency assays for advanced therapy medicinal products (ATMPs).
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Designed for professionals working across regenerative medicine, stem cell therapies, and cell-based product development, the content explores how potency is conceptualized, evaluated, and integrated into broader CMC and development strategies.

The report discusses regulatory expectations for potency assays in cell therapy, common scientific and operational challenges, and critical decision points that can significantly influence product development, comparability strategies, manufacturing consistency, and clinical translation. Topics include mechanism of action considerations, assay relevance, product complexity, analytical limitations, and the evolving role of potency testing throughout early and late-stage development. Rather than serving as a technical protocol or prescriptive assay-development manual, this resource is intended to support scientific understanding, strategic thinking, and informed decision-making for biotechnology companies, academic groups, investors, and professionals involved in advanced cell therapy development.

Particularly relevant for teams working with pluripotent stem cell–derived therapies, regenerative medicine products, and complex biological systems where traditional potency paradigms may not fully apply.

Potency is often discussed, but rarely straightforward in practice. Regulatory expectations continue to evolve, mechanisms of action are frequently complex, and defining scientifically meaningful potency assays remains a major challenge across the field of cell therapy and regenerative medicine. This report explores key considerations, common misconceptions, and strategic perspectives that can help organizations navigate potency assessment more effectively throughout development.
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