Events & Insights
As cell therapies advance from early development toward commercialization, Chemistry, Manufacturing, and Controls (CMC) strategy has become a critical determinant of regulatory and clinical success. A proactive, evolving CMC roadmap can help sponsors anticipate regulatory expectations, reduce manufacturing risk, and avoid costly delays throughout development.
In this featured article published by Cell & Gene Therapy Review, Roger Herr, PhD, explores the most common CMC pitfalls facing today’s cell therapy developers and shares practical strategies for building a dynamic roadmap that supports scalable manufacturing, regulatory readiness, and long-term program success.
Whether you’re preparing for your first IND or planning for commercial manufacturing, this article provides valuable insights into developing a robust CMC strategy that helps keep your program on track.
Read the full article to learn how early CMC planning can help accelerate development while minimizing regulatory and manufacturing risk.
