In this Manufacturing Chemist article, Certara’s Drs. Hien Anh Bruno and Deven Shah discuss the CMC (Chemistry, Manufacturing, and Controls) challenges of developing cell and gene therapies. Read this article to learn the best practices for mitigating these hurdles including tips for
- process and quality control
- phase-appropriate sourcing of raw materials,
- establishing material qualification and management protocols,
- optimizing the manufacturing process,
- managing supply chain complexity and
