Drugs

FDA Backs Shift to Drug Continuous Manufacturing

CDER Office of Pharmaceutical Quality deputy director Lawrence Yu says that while it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards and FDA is encouraging companies to consider making the effort. Writing in an FDA Voice blog post, Yu says that continuous manufacturing (in contrast with the older-style batch manufacturing) enables much faster production and more reliable products through an uninterrupted process. “In some cases,” he writes, “manufacturing that takes a month by batch technology might only take a day using continuous manufacturing techniques.”

Also, by eliminating breaks between steps and reducing opportunities for human errors during the starts and stops in the batch process, continuous manufacturing is more reliable and safer, he says.

Yu further cites the added benefit that more efficient production of quality products can drive down manufacturing costs, possibly resulting in lower drug prices to consumers. He says the new process also allows manufacturers to respond much quicker to changes in demand, potentially contributing to prevention of drug shortages.

Earlier this month, Yu writes, FDA approved for the first time a manufacturer’s change in production method from batch to continuous manufacturing. The approval was for Janssen’s Prezista (darunavir), indicated for treating HIV-1 infection. He says that the company’s efforts in manufacturing advancement were facilitated by the use of a recent FDA draft guidance on advancement of emerging technology applications to modernize the pharmaceutical manufacturing base.

“Progress comes at an opportune time,” Yu concludes. “The medications we use are changing. 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 the medications used by the American public.”

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