10/23/2024 | Press release | Distributed by Public on 10/24/2024 11:13
october 23, 2024
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:
"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