CMC Best Practices For Cell And Gene

By Kent Amsberry, Ph.D, RAC, Principal Scientist, CMC and Yin Lai, Ph.D, MSc., RAC, Principal Scientist, CMC, Cardinal Health Regulatory Sciences

Compared to more traditional therapeutics, the innovative development programs, complex manufacturing processes, and inherent properties of cell and gene therapies (CGT) require an intense focus on chemistry, manufacturing and controls (CMC) during regulatory submissions

This focus on CMC information during regulatory approval, combined with the continuously evolving regulatory landscape, creates the potential for delays and puts patients in need of life-saving therapies in jeopardy. While CGT is still a nascent industry, regulatory consultants are rapidly gaining experience and can help companies mitigate risk on the path to approval. Experts share some best practices to help avoid CMC pitfalls during cell and gene therapy product development.