Cell and gene therapy manufacturing depends on specialized raw materials, ranging from upstream reagents to downstream excipients, that are essential to product quality, consistency, and safety. Despite their importance, raw materials are often overlooked in regulatory change strategies. This has become especially relevant in the aftermath on the COVID-19 pandemic where supply chain disruption further exposed the risks of single-source reliance and inflexible 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.

This article highlights the role of both suppliers and drug developers in ensuring raw material consistency, quality, and regulatory compliance.

Key learning points:

• Challenges of raw material changes across clinical development and commercial manufacturing and the regulatory considerations involved
• Best practices for mitigating risks associated with post-approval modifications
• Importance of collaboration between suppliers and end users to minimize regulatory risks