FDA Urges Industry Comments on Continuous Manufacturing

FDA continues to urge the adoption of continuous manufacturing (CM) by drug manufacturers. The agency is seeking comments until 9/21 on about the science, technology, and best practices concerning CM, says CDER Office of Pharmaceutical Quality director Michael Kopcha in an FDA Voice blog post. He notes that despite the initial costs to move to CM, it can shorten production times and improve manufacturing efficiency. “CM also allows for more nimble testing and control that can help reduce the likelihood of manufacturing failures,” he writes. And control strategies could help prevent drug shortages.

In the blog posting, Kopcha notes that companies interested in CM should engage with the agency’s Emerging Technology Team (ETT) for both new and existing drugs. Two companies recently interacted successfully with ETT — Vertex for cystic fibrosis drug Orkambi (lumacaftor/ivacaftor), and Janssen Products for Prezista (darunavir), indicated for treating HIV-1 infection.