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Lawrence Yu

FDA Compliance

Modernizing the Pharmaceutical Manufacturing Base

Continuous manufacturing has a strong impact on drug quality

Published: Monday, May 9, 2016 - 13:57

If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques being used. That’s because not much has changed in pharmaceutical production during the last 50 or so years.

For decades, most drugs have been manufactured using what is known as “batch” technology”—a process whereby the ultimate finished product has been made after many stops and starts in a series of steps. Unfortunately, each break in the process causes inefficiency and delay, as well as the increased possibility of defects and errors.

Today, continuous manufacturing enables much faster production and more reliable products through an uninterrupted process. How much faster is continuous manufacturing? In some cases, manufacturing that takes a month by batch technology might take only a day using continuous manufacturing techniques.

Of course, speed alone wouldn’t matter if continuous manufacturing compromised quality. But by eliminating breaks between steps and reducing opportunities for human errors during the stops and starts in the batch process, continuous manufacturing is more reliable—and safer. That’s a powerful combination.

There’s the added benefit that more efficient production of quality products can drive down manufacturing costs, possibly resulting in lower drug prices for consumers. Continuous manufacturing also allows manufacturers to respond much quicker to changes in demand, potentially contributing to prevention of drug shortages.

We are seeing a growing number of manufacturers building continuous manufacturing into their processes. One manufacturer, Vertex, the maker of a cystic fibrosis drug called Orkambi (lumacaftor/ivacaftor), has been using the continuous manufacturing process for this drug since its approval date in July 2015.

Last Friday marked another significant step toward integrating continuous manufacturing into pharmaceutical production. The Food and Drug Administration (FDA) approved, for the first time, a manufacturer’s change in its production method from “batch” to continuous manufacturing. This new approval is for manufacturing Janssen products. The company’s efforts in manufacturing advancement were helped by using the FDA’s recently released draft guidance to industry, “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.” The guidance was produced by the agency’s Emerging Technology Team, which is designed to help manufacturers implement a variety of technological advancements.

Progress always seems to come at an opportune time. 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. The FDA will continue its 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 public.

Although it’s not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards. The FDA encourages others in the pharmaceutical industry to consider similar efforts.


About The Author

Lawrence Yu’s picture

Lawrence Yu

Lawrence Yu, Ph.D., is Deputy Director of the FDA’s Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research. Yu joined the FDA in 1999. His research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical quality by design. Yu received bachelor’s and master’s degrees in chemical engineering from Zhejiang Institute of Technology, a master’s degree in pharmaceutics from the University of Cincinnati, and a Ph.D. in pharmaceutics from the University of Michigan.