Search ARM

Addressing potency-assay related development delays for cell and gene therapies


Results of a scientific exchange between FDA and developers


Results of a scientific exchange between FDA and developers

Potency assays present a significant challenge for developers and regulators of gene and cell therapy products. Regulators require developers to measure the potency of all biologics, including gene and cell therapies to ensure that a consistent product is delivered to all patients. As a new and complex field of therapeutics, cell and gene therapies require a bespoke and multi-faceted approach to demonstrating potency. For developers, this represents a significant investment with uncertain returns, as achieving regulatory acceptance of a developer’s approach to demonstrating potency has often led to delays. The following white paper was developed in response to an October 19 meeting with regulators and other concerned parties, and demonstrates ARM’s commitment to collaboration with regulators and other stakeholders to further support development and patient access to these breakthrough therapies.

Download Report