CMC obstacles in CGT: 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.


Learn from Subbu Viswanathan, Compliance Officer & Senior Vice President, Quality, Security and Compliance and Marc Puich, Senior Vice President, Business Development as they discuss how manufacturers must proactively address six major types of obstacles early in their clinical trial process to prevent significant, costly regulatory delays later. 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.