The European Medicines Agency has approved the continuous manufacturing production of the HIV drug Prezista (darunavir) by Janssen Pharmaceuticals, a unit of Johnson & Johnson.
Production of the 600-mg tablets bound for the EU is underway at the company’s Gurabo, Puerto Rico, facility. The approval by the EMA will allow Janssen to reduce manufacturing and testing cycle time, reduce waste and environmental impact, and lower process risk, the company said. In addition to the continuous manufacturing process, traditional “batch” production of Prezista will continue.
“Continuous manufacturing allows us to reduce inventory levels and make a product in a way that is closer to being ‘on demand,’ so that we can adjust our manufacturing to meet product demand fluctuations while being more efficient,” Mauricio Futran, VP of advanced technology for Janssen Supply Chain, told FiercePharmaManufacturing. “Looking forward, we are testing continuous manufacturing at other Janssen production sites for both select commercialized products and some that are still in the development phase.”
Last year, the FDA gave Janssen the green light for the continuous manufacturing process that it has been working on for 5 years. The agency approved the move from batch to the new technology for production of Prezista at the Gurabo facility.
The company worked with Rutgers University and the University of Puerto Rico on developing the technology, which is designed to integrate weighing, milling, blending, compression and coating into a single line. The process requires less production space and also allows real-time release testing, which reduces the production timeline for Prezista from two weeks to a single day. If a correction is needed, an entire batch does not have to be dumped.
Janssen has said that pending additional regulatory approvals, it would like to use the technology to manufacture 70% of its highest-volume products.