Addressing potency-assay related development delays for cell and gene therapies: Results of a scientific exchange between FDA and developers

Addressing potency-assay related development delays for cell and gene therapies:
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. On October 19th, an all-day meeting of regulators, developers, and other
concerned parties was held to address the challenge of potency assay development and validation for
cell and gene therapies.

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