Ensuring compliance through collaboration: managing raw material changes in cell and gene therapy regulatory filings

The manufacturing of cell and gene therapy products relies on a complex network of specialized raw materials, each playing a vital role in ensuring product consistency, efficacy, and safety. From cell selection reagents and gene-editing enzymes used in upstream processes to process buffers, excipients, and cryoprotectants in downstream production, these materials directly impact the quality and performance of advanced therapies. However, despite their critical role, raw materials are often overlooked in regulatory filing change management strategies. Global supply chain disruptions, intensified by the COVID-19 pandemic, have highlighted the vulnerabilities associated with reliance on single-source suppliers and rigid material registration practices. To mitigate these risks, regulators and industry stakeholders are shifting toward flexible, science-based approaches that integrate QbD principles into the regulatory filing and management of raw materials. Ensuring compliance with global regulatory filing expectations requires a proactive approach to raw material change management encompassing shared responsibility between drug developers and suppliers. This article examines the challenges of raw material changes across clinical development and commercial manufacturing, the regulatory considerations involved, and best practices for mitigating risks associated with post-approval modifications. It highlights the importance of collaboration between suppliers and end users to minimize regulatory risks. By exploring case studies, this article highlights the role of both suppliers and drug developers in ensuring raw material consistency, quality, and regulatory compliance.

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