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

Published: 10 May 2021
Innovator Insight
Subbu Viswanathan,
Subbu Viswanathan
Compliance Officer & Senior Vice President, Quality, Security and Compliance, Vineti, Inc.
Marc Puich
Marc Puich
Senior Vice President, Business Development, Vineti, Inc.
Marc focuses on leading the global sales activities for the Vineti Platform. Prior to joining Vineti Marc, held various positions at Werum IT Solutions, the leading provider of Manufacturing Execution Systems for the Pharmaceutical Industry. There, he was directly involved with sales and implementation of Werum’s PAS-X MES, as well as supporting organizations as they continued to drive benefits post go-live. Marc came to Werum with ten years consulting experience as a partner focused on the pharmaceutical and biotech sectors at Tefen USA. He holds a Bachelor’s in Physics from UC Berkeley and Master’s degree in Industrial Engineering and Engineering Management from Stanford University.

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.

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