Guidance on CMC elements for somatic cell therapy products
This article was originally published in The Gold Sheet
Executive Summary
FDA issued a guidance on CMC information for human somatic cell therapy INDs on April 10. It replaces an August 2003 draft. The review instructions and template described in the guidance are designed to help FDA reviewers in evaluating INDs for these products. The guidance contains detailed requirements for characterizing master cell banks, working cell banks and reagents. It also states that manufacturers should include a detailed description of all procedures use during the collection, production and purification of cellular therapy products