FDA OK’s Janssen’s Switch to Continuous Production Line

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

Company officials confirmed last week that a production line at the company’s Puerto Rican plant producing the HIV drug Prezista converted 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, with continuous quality monitoring throughout.