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FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
In a blog posted on FDA’s website on April 12, 2016, Lawrence Yu, PhD, FDA deputy director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Researcher (CDER), discussed the steps FDA is taking to promote continuous manufacturing to improve quality in the pharmaceutical production process.
For the first time, on April 8, 2016, FDA approved Janssen Products LP’s change in production method from batch to continuous manufacturing for the production of Prezista (darunavir), an HIV treatment. In the blog, Yu says FDA encourages companies to make the change to continuous manufacturing.
“The medications we used are changing,” Yu writes. “We are entering an era of precision medicine, when drugs must be made with unique features and provided more quickly to patients in need. FDA will continue our efforts to encourage the advancement of continuous manufacturing as one of a variety of ways to enhance the quality of medicines used by the American public.”
Yu also cites the FDA guidance, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, which FDA released in December 2015. The guidance allows companies to submit pre-submission questions and proposals about the use of new technologies to a group within CDER, the Emerging Technologies Team (ETT). Yu says the guidance is meant to assist pharmaceutical companies in implementing technological advancements in the manufacturing process.
Yu also admits, although it may not be easy for manufacturers to make the switch from bath to continuous manufacturing, there could be significant rewards. Some of these rewards, he notes, include driving down manufacturing costs, which may result in lower drug prices for consumers.