The Challenges of Potency Assay Development for Cell-based Medicinal Products in Europe

Published on: May 5, 2015

Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products. This paper highlights several approaches to consider when designing the potency assay strategy in the framework of current EU regulatory expectations.

Valerie Pimpaneau, François Gianelli, Anne Dupraz Poiseau & Jean-Hugues Trouvin, (Professor at Paris Descartes University).

May 2015 – Regulatory Rapporteur