By Denise Krohn, Ann McMahon
Published in: Endpoints Webinars
Published on: April 4, 2022
A gene therapy’s path from the research lab to the clinic and ultimately the market requires manufacturing processes that will meet regulatory requirements and the logistics to get therapies to clinical trial sites. Having Chemistry, Manufacturing and Controls (CMC) in place early can help avoid issues during regulatory reviews. Understanding packaging design and storage requirements as well as having a distribution plan are also critical to successful trials.
