CMC And Regulatory Considerations For CRISPR Therapies

Chemistry, Manufacturing, and Controls (CMC) is a process that ensures products are produced safely, consistently, and of high quality by designing and testing manufacturing processes, materials, and final products. This presents a different set of guidelines from Current Good Manufacturing Practices (cGMP), as the former refers to product quality, while the latter refers to quality management. But why is CMC so important during all stages of the drug development cycle after drug discovery?

This article explores the details of CMC and Critical Quality Attributes (CQAs), which play an important role in gene editing. CQA's are properties that should be within specific limits to ensure product quality. You will also learn about the Common Technical Document (CTD), which is a set of specifications for registering medicines, detailing how the gRNA is manufactured, controlled, tested, and stored in Module 3.