Navigating the Path to the Clinic and Beyond for Gene Therapies
Summary: 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.
In this webinar, hear from Catalent panelists Denise Krohn, VP of Quality (Harmans/BWI), and Ann McMahon, Program Director Clinical Supply Services and Drug Product Technologies Integrations, as they discuss navigating the path.