The Evolving Landscape of Potency Assays.

There is a "goldilocks" aspect to potency assays. On the one hand, a comprehensive evaluation of the cell product with detailed quantitative measurement of the critical quality attribute/s of the desired biological activity is required. On the other hand, the potency assay benefits from simplification and lean approaches that avoid unnecessary complication and enhance robustness, to provide a reproducible and scalable product. There is a need to balance insightful knowledge of complex biological healing processes with straightforward manufacture of an advanced therapeutic medicinal product (ATMP) that can be administered in a trustworthy cost-effective manner. While earlier chapters within this book have highlighted numerous challenges facing the potency assay conundrum, this chapter offers a forward-looking perspective regarding the many recent advances concerning acellular products, cryopreservation, induced MSC, cell priming, nanotechnology, 3D culture, regulatory guidelines and evolving institutional roles, that are likely to facilitate potency assay development in the future.