- The FDA has cleared Janssen to switch production of its HIV drug Prezista (darunavir) from batch to continuous manufacturing, the first time it has ever allowed such a change.
- Janssen, which is part of Johnson & Johnson (J&J), has been developing its manufacturing capabilities with support from Rutgers University. Last year, the company expanded its partnership with $6 million in new funding.
- Continuous manufacturing, adopted in other industries but not yet common in pharma, promises to reduce production time and waste compared to traditional batching. The FDA has pushed for companies to make the switch.
In a blog post associated with the approval, FDA Deputy Director Lawrence Yu called the approval a "significant step" and encouraged other companies to follow Janssen's lead.
Craig Stoltz, a Janssen spokesperson told in-Pharma Technologist that the switch to continuous processing "reduced testing-to-release time from 30 days to a target of 10 days." Yu indicated other companies could see even greater reduction in production times.
Janssen is one of several companies, including Eli Lilly and GlaxoSmithKline, at the forefront of brining continuous manufacturing into pharma. Last week, Lilly made a nearly $40 million investment in a new continuous API facility in Ireland.
Eventually, if the FDA has its way, more companies will make switch from batch manufacturing. The FDA has emphasized the major benefits of CM, including greater reliability and flexibility to meet demand.
The federal government has also been advocating for greater adoption, with a report from the White House suggesting manufacturing costs could be reduced by up to 50% while simultaneously reducing facility size.