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.
During this webinar, hear from Catalent panelists Denise Krohn, VP of Quality (Harmans/BWI), and Ann McMahon, Program Director Clinical Supply Services & Drug Product Technologies Integrations, as they discuss navigating the path.
Join us to learn more about:
- Getting ready for a gene therapy regulatory inspection
- Hosting in-person and video audits and inspections during a pandemic
- How GMP suite readiness impacts the path to pivotal trials and commercial supply
- Designing the proper packaging, including labeling and patient kits, to meet trial needs
- How integrated services for manufacturing and clinical supply can help streamline processes and get therapies to patients faster
This webinar will be targeted to senior technical staff and business development professionals in the pharmaceutical and biotech industries.