Key CMC strategies for the development of cell and gene therapies
As complex, diverse and personalized treatments, cell and gene therapies (CGTs) face common development constraints in Chemistry, Manufacturing and Controls (CMC). Sanjay Jain, PhD, PGMP, Senior Director, Global Regulatory Affairs Strategy, Product Development and Market Access Consulting at Fortrea, recently shared an overview of how CMC differs for CGTs and discussed the complexities and challenges during development along with potential strategies to overcome these complications. His in-depth white paper covers:
- Good Manufacturing Practice (GMP) for a typical clinical scale autologous CAR T-cell therapy
- Gene therapy product manufacturing
- CMC complexities and challenges faced during development
- Strategies for overcoming CGT development challenges
- Critical quality attributes (CQAs) for cell and gene therapy products
- How a risk-based approach and regulatory agency guidelines can support CMC efforts for CGTs
“Chemistry, manufacturing and controls of CGTs represent a key challenge in the industry,” said Dr. Jain. “A CMC strategy should be developed while keeping the end goal in mind, knowing that one size does not fit all.” Dr. Jain also encourages sponsors to implement a CMC strategy that aligns with regulatory expectations and provides in-depth product knowledge. His paper highlights the importance of early interactions with regulators to help understand agency expectations and proactively address the unique challenges faced in clinical development to advance these highly technical and extremely specialized products.
Learn more in the white paper linked below.
For more on Fortrea's experience in regulatory strategy consulting, visit https://www.fortrea.com/solutions/fortrea-consulting-services/regulatory-strategy-consulting.html
