EMA Approves Continuous Manufacture of Prezista

Janssen’s HIV drug is now available in Europe.

Janssen Pharmaceutical Companies of Johnson & Johnson and its manufacturing arm, Janssen Supply Chain (JSC), announced that the EMA has approved continuous manufacturing with real-time release testing for the company’s HIV drug Prezista.

The green light will allow for the immediate production of Prezista (darunavir) 600-mg tablets via continuous manufacturing at JSC’s Gurabo facility in Puerto Rico. According to industry media and company statements, Janssen became the first company to win approval to convert from batch to continuous manufacturing by the FDA in April 2016.

The result of a five-year development program, Janssen collaborated with Rutger’s Structured Organic Particulate Systems (C-SOPS) to develop a viable, commercial continuous manufacturing process and demonstrate the efficiency of both the process and real-time release for the tablet-based HIV therapy. The recent approval is proving the manufacturing concept’s growing acceptance and application by the pharma industry.

In its announcement, the company said, “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.” According to JSC, the fact that it is processed via continuous manufacturing will make a big difference, reducing a two-week production timeline down to a one day — while integrated process analytical technologies and controls will assure quality in real-time.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.