Readiness through Planning and Alignment: Guiding Gene Therapies from Clinic to Market
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 executive summary, learn how integrated service providers can streamline manufacturing, development and commercialization for optimal regulatory and process outcomes for gene therapy programs.