- European regulators have given the go-ahead to a Johnson & Johnson HIV drug made through a manufacturing process increasing in popularity across the pharmaceutical industry.
- Janssen, the big drugmaker's research arm, announced on Friday that the European Medicines Agency certified 600 mg tablets of Prezista (darunavir) produced at a continuous manufacturing facility in Gurabo, Puerto Rico.
- "With the EMA Prezista continuous manufacturing approval, Janssen is able to reduce manufacturing and testing cycle time, reduce waste and environmental impact, and lower process risk, all while maintaining existing product quality in the delivery of innovative therapies for patients," Janssen said in a June 23 statement.
When it comes to manufacturing, the biopharma sector has largely relied on batch production, which — as its name suggests — creates big batches of active pharmaceutical ingredient (API) or drug product through a series of steps. But the practice of continuous manufacturing is starting to pick up speed thanks in part to a push from regulators.
Earlier this month, for instance, the Food and Drug Administration called for public input about the industry adopting continuous manufacturing. In the past, the agency pushed drugmakers to move from batch technology to the new process, and just last year gave Janssen a first-of-its-kind approval to do just that with Prezista.
Other large pharmas are also jumping onto the continuous manufacturing wave. Eli Lilly last April said it planned to invest €35 million ($40 million) in a Ireland-based continuous manufacturing plant focused on API production for its late-stage pipeline.
Meanwhile, Novartis and the Massachusetts Institute of Technology are entered into a 10-year-long research project to establish the Center for Continuous Manufacturing, which aims to create technologies that speed up drug development and reduce waste, costs and the necessary scale of production sites.
Back at Janssen, the switch at the Gurabo plant has cut the number of rooms needed to make Prezista from seven to two, and trimmed production timelines down from two weeks to one day, according to the company.
Going forward, Johnson & Johnson wants to create 70% of its "highest-volume products" via new process within the next eight years and narrow the time it takes to development and test its drugs by 80%.