Risk-based strategies for viral safety assurance

Le résumé fourni par la source

Viral safety in advanced therapy medicinal product (ATMP) manufacturing is an essential regulatory and patient safety requirement—yet viral safety assurance for these products presents some significant challenges. Viral safety measures using orthogonal approaches are a regulatory expectation, provided there is no negative impact on product quality and safety. For cell therapies (CTs), these options are limited due to the nature of the products. In most cases, CT product sponsors must rely more heavily on the prevention and detection pillars of the viral safety strategy as opposed to the clearance pillar. Current CT-specific guidance related to viral safety is limited and there is uncertainty around what is required for a viral safety strategy for CTs. To help industry navigate these complexities, the ATMP Phorum has published this new paper to provide practical, real-world insights into viral safety assurance for ATMP products. This paper recommends a structured, risk-based approach that evaluates potential viral contamination sources—ranging from donors and raw materials to operators and facilities—using a matrix model. Applying this model to CAR-T therapies demonstrates how tailored mitigation strategies can effectively reduce viral risks throughout the manufacturing process. The paper also highlights the importance of considering global regulatory guidance and leveraging advanced technologies, such as next-generation sequencing, for comprehensive viral detection. The principles and strategies illustrated for CAR-T therapies are broadly applicable across various CT modalities, including those derived from stem cells and other immune cell types.

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