FDA Approves C-SOPS-Supported Continuous Manufacturing Line

Following a five-year partnership with Rutgers University's Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) and the University of Puerto Rico, Janssen Supply Chain has been granted approval by the U.S. Food and Drug Administration (FDA) to produce PREZISTA (darunavir) 600 mg tablets on a continuous manufacturing production line at its plant in Puerto Rico. By replacing batch processing, continuous manufacturing represents a key component of advanced pharmaceutical manufacturing and produces improvements in quality, safety, efficiency, cost, and speed to market. In effect, the process consolidates manufacturing steps into on line that integrates weighing, milling, blending, compression, and coating.

This announcement follows on the heels of a White House council naming continuous pharmaceutical manufacturing an "emerging priority."

“The approval by the FDA to begin manufacturing a Janssen product using continuous manufacturing is both exciting and fulfilling in our ongoing efforts to support the introduction of continuous manufacturing techniques within the pharmaceutical industry,” said Fernando J. Muzzio, director of C-SOPS and distinguished professor of chemical and biochemical engineering at Rutgers School of Engineering. “Working together with agency and industry, we have developed systems and regulations to speed this transformation along.”

Muzzio has spearheaded this ongoing project alongside Marianthi Ierapetritou, professor and chair of the Department of Chemical and Biochemical Engineering, and Alberto Cuitino, professor and chair of the Department of Mechanical and Aerospace Engineering. In October 2015, the FDA awarded $4.9 million in grant funding to institutions in a research consortium based at Rutgers School of Engineering. Earlier last year, Janssen Supply Chain furthered its strategic partnership with the school by providing more than $6 million to expand ongoing research efforts supporting the company’s introduction of continuous manufacturing.

Read more at PharmTech News>>FDA Approves Tablet Production on Janssen Continuous Manufacturing