FDA Approves Tablet Production on Janssen Continuous Manufacturing Line
FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.
Apr 12, 2016
By Pharmaceutical Technology Editors
With the April 8, 2016 FDA approval of an update in the manufacturing of PREZISTA (darunavir) 600 mg tablets, Janssen Supply Chain (JSC) can now produce tablets on a continuous manufacturing production line at its manufacturing facility in Gurabo, Puerto Rico. The use of continuous manufacturing to replace the existing batch manufacturing process is a result of a five-year partnership with Rutgers University and the University of Puerto Rico to develop a process that integrates all manufacturing steps (weighing, milling, blending, compression, and coating) into one single line.
Janssen collaborated with researchers in the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) to develop a full-scale continuous manufacturing direct-compaction production line at the Rutgers facility for testing, and the continuous manufacturing line at JSC’s facility was built using the design (1). In May, 2015, JSC expanded its partnership with C-SOPS to support ongoing continuous manufacturing research (2).
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, JSC is responsible for supplying medicines to markets around the world by connecting global supply to meet regional and local demand. “JSC continues to strengthen its plant capabilities and processes with optimal resource allocation and reduced complexity in manufacturing procedures in order to accelerate the ability to anticipate and respond to customer needs. By incorporating one of the industry’s first full production-scale continuous direct compression solid oral dosage manufacturing facilities in Puerto Rico, JSC will reduce manufacturing and testing cycle time, reduce waste and environmental impact, and lower process risk, all while maintaining existing product quality,” the company stated in an announcement. Continuous manufacturing reduced a two-week production timeline to a one-day production timeline and allows continuous monitoring of quality, says the company.
The team is also investigating applications of continuous-manufacturing techniques in manufacturing other pharmaceutical therapies, which could lead to reduced scale-up time and eventually shorter time-to-market for other Janssen medicines. With the integration of continuous manufacturing, Janssen and J&J aim to “manufacture 70% of highest-volume products using continuous manufacturing within eight years, increase yield by reducing waste by 33%, and reduce manufacturing and testing cycle time by 80%” (3).