ISCT’s position on potency assay development for cellular products

by Alexey Bersenev on February 14, 2013 · 0 comments

in cell product, reviews

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Potency assay is important and even critical part of cell product characterization. Potency determines quality of cellular product and underlie the mechanism of therapeutic action (MOA). International Society for Cellular Therapy (ISCT) has published a position paper on potency assays for cell product developers. I’d highly recommend to read this great overview for every cell product developer!

Potency testing must demonstrate the relevant biologic activity or activities of the product. It is not a requirement for potency testing to reflect all of the product’s biologic functions, but it should indicate one or more relevant biologic functions. Testing all biologic functions of a product is rarely feasible, given the multimodal MOA of CTP. Testing a subset of the most relevant biologic function or functions is a practical, scientifically meaningful strategy that meets regulatory expectations.

The article also provides 5 case studies of commercial cellular products on clinical stages of development.

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