Staying Ahead Of Regulatory Change: CMC Strategies For Cell And Gene Therapy Development

The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach. Increased scrutiny on Chemistry, Manufacturing, and Controls (CMC), coupled with FDA resource constraints, means that proactive planning and regulatory engagement are more important than ever. Unlike traditional drugs, CGTs are complex, often personalized, and highly sensitive to manufacturing changes, making CMC planning as critical as clinical strategy. A key challenge in CGT development is managing manufacturing changes through comparability, demonstrating consistency in product quality, safety, and efficacy across production shifts. This requires early and detailed planning, including phase-appropriate analytical strategies and stability data to mitigate delays and avoid additional clinical studies.

Veristat supports sponsors with tailored regulatory strategies, robust CMC planning, and expert guidance through accelerated pathways. With over 20 CGT submissions completed in the past five years, Veristat provides deep experience navigating this dynamic space—helping sponsors stay ahead of regulatory changes while advancing life-saving therapies to patients.