Newswire

FDA Calls for Stronger Potency Upkeep in CGT Manufacturing

Scientist working in a laboratory

The FDA’s CBER director emphasized the need for stronger potency maintenance in cell and gene therapy (CGT) manufacturing. This call for enhanced oversight aims to ensure that patients can trust that the products they receive will perform as intended. The FDA’s focus on potency is critical as it directly impacts the efficacy and safety of these therapies.

This guidance may prompt manufacturers to reassess their quality assurance processes and implement more rigorous testing protocols. Suppliers and buyers in the CGT space should prepare for potential changes in regulatory expectations and consider how these adjustments might affect production timelines and costs.

Source: pharmaceutical-technology.com · Image: Scientist in a laboratory Esculab by Esculab, CC0, via Wikimedia Commons

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