Janssen Switches Over to Continuous Production Line Following FDA Approval

Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light April 8 from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method mid-cycle.

Company officials confirmed April 12 that a production line at the company’s Puerto Rican plant producing the HIV drug Prezista converted Friday to continuous manufacturing, a process that replaces the traditional stop-and-start production cycles of batch production with a 24-hour process intended to cut waste and production time.

The company estimates that this production change will reduce manufacturing and testing cycle times by 80 percent and cut waste inherent in the batch production process by 30 percent.

It also asserts that the process will be more efficient than batch production, with continuous quality monitoring throughout.

While Janssen is not the first drug company to use a continuous production process, FDA officials say it is the first to transition away from batch production and can serve as a model for other drugmakers.

“Although it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards,” Lawrence Yu, deputy director of CDER’s Office of Pharmaceutical Quality, said Tuesday. “FDA encourages others in the pharmaceutical industry to consider similar efforts.”

Janssen says that it has been testing the continuous production process for several years, although Friday’s run was the first to be commercially distributed.

The company added that it is weighing whether to apply the continuous manufacturing process to “other pharmaceutical therapies, which could lead to reduced scale-up time and eventually shorter time-to-market for other Janssen medicines.”

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of GMPs and the Quality Systems Regulation — information you need to stay in compliance.