USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy, and more

Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics regulatory submission.

CMC activities ensure that a biologic or biosimilar product remains safe and consistent from drug discovery through technical development and production, and ultimately through regulatory approval and commercialization. But various factors — new guidances for industry, biologic product categories, advances in published research — all add to the difficulty of learning about CMC for pharmaceuticals, let alone mastering it.

RAPS spoke with Patricia Cash and Joe Quinn, presenters at Biologics CMC: Regulatory Challenges and Trends, a workshop on 12-13 March and 10-11 October 2024, to get their takes on common problems in biologics CMC, pitfalls that often affect CMC experts trying to better navigate regulatory affairs, and more…