CMC obstacles in cell and gene therapy: four solutions to solve six challenges

Advanced therapy developers find themselves paying increasing attention to three letters — CMC. Short for “Chemistry, Manufacturing, and Controls,” this portion of the regulatory approval package has taken on predominant importance in cell and gene therapies (CGTs), and represents significant risk to clinical trial and approval timelines. At least 14 products were delayed in 2020 due to CMC issues. Manufacturers must proactively address six major types of obstacles early in their clinical trial process to prevent significant, costly regulatory delays later. Four proven solutions can address these challenges, automate data management and compliance, and streamline the path to a robust CMC package. This article addresses these challenges and presents relevant solutions, in the interest of simplifying CMC activities for the benefit of patients and the entire advanced therapy sector.