EMA Approves Janssen Drug Made Via Continuous Manufacturing

June 26, 2017
Pharmaceutical Technology Editors

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

Janssen Supply Chain (JSC), a part of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that the European Medicines Agency (EMA) has approved continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir) 600-mg tablets, the company said in a June 23, 2017 press release. The product is currently made on a continuous production line at JSC’s manufacturing facility in Gurabo, Puerto Rico.

In 2016, Janssen became the first in the industry to receive FDA approval to convert from batch to CM, with FDA’s approval of Prezista made on the Gurabo CM line. Benefits include reduced manufacturing and testing cycle time, reduced waste and environmental impact, and lower process risk, all while maintaining existing product quality.

Effective immediately, Prezista tablets manufactured on the CM line at the JSC’s Gurabo facility can be used to treat patients in the 28 EU Member States. A similar approval from Swissmedic on May 28, 2017 allows Prezista 600 mg tablets produced on the Gurabo CM line to be sold and used in Switzerland. Currently, JSC is also investigating applications of CM techniques in the development and manufacturing other pharmaceutical products, which could lead to reduced scale-up time and eventually shorter time-to-market for other Janssen medicines.

Source: JSC