The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

Key Takeaways include:

• Understand how evolving FDA and EMA expectations are shaping CMC strategies for cell therapies, particularly around comparability, process changes, and lifecycle management as programs move toward commercialization.
• Learn how to align manufacturing strategies with regulatory expectations early in development, helping teams design scalable, globally viable programs and avoid costly rework later.
• Gain perspective on emerging regulatory trends impacting cell therapy development, including increasing expectations for robust control strategies, stronger analytical packages, and greater readiness for scale and lifecycle management.