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The agency is looking for industry input on best practices for continuous manufacturing.
In an FDAVoice blog post dated Sept. 11, 2017, Michael Kopcha, PhD, RPh, FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) announced a public docket for comment, open until Sept. 21, 2017, to gather industry input as part of the agency’s support for the use of continuous manufacturing (CM) in pharmaceutical manufacturing. FDA has seen the development of variations of CM techniques by the industry, and plans to provide principals and expectations regarding the use of CM. The agency hopes to receive feedback on current published documents on CM, including the best practices document published by the Center for Structured Organic Particulate Systems (C-SOPS).
Kopcha also discussed the benefits and challenges of implementing CM. Citing shortened production times and improved efficiency, Kopcha stated that CM “allows for more nimble testing and control that can help reduce the likelihood of manufacturing failures.” CM can also be specifically tailored to product needs. The study of CM was authorized by the 21st Century Cures Act, and FDA’s Emerging Technologies Team (ETT) is available to help companies interested in implementing CM.
“We have already seen two companies that have implemented CM and benefited from early engagement with the ETT. Vertex has been using a CM process for their cystic fibrosis drug, Orkambi (lumacaftor/ivacaftor), since its approval in July 2015. In 2016, FDA approved a change in production from batch to continuous manufacturing for Janssen Products’ medication to treat HIV-1 infection, Prezista (darunavir),” Kopcha stated. “Assuring the availability of quality, safe, and effective medications to the American public is a priority for FDA. CM, and other innovative manufacturing and control strategies, offer ways for the pharmaceutical industry to continue to help support this goal.”