FDA Approves Tablet Production on Continuous Manufacturing Line

Achievement date: 
2015
Outcome/accomplishment: 

A key research focus of the Center for Structured Organic Particulate Systems (C-SOPS)—the continuous manufacturing of solid dose pharmaceuticals—has made a major impact on commercialization across an entire industry critical to the U.S. economy . On April 8, 2016, the FDA approved a first-ever change in the manufacturing of tablets by C-SOPS industrial partner Janssen Supply Chain (JSC). JSC can now produce tablets on a continuous manufacturing production line based on a C-SOPS design at its manufacturing facility in Gurabo, Puerto Rico. CSOPS is a National Science Foundation Engineering Research Center (ERC) headquartered at Rutgers University in partnership with New Jersey Institute of Technology (NJIT), Purdue University, and the University of Puerto Rico-Mayaguez.

Impact/benefits: 

The processes and techniques used in pharmaceutical production, known as batch manufacturing, have not changed significantly in over 50 years. Continuous manufacturing (CM) enables much faster production and more reliable products through an uninterrupted process. In some cases, manufacturing that takes two weeks or more using batch technology might only take a day using CM techniques. The process also reduces waste and environmental impact and allows continuous monitoring of quality. More efficient production of quality products can drive down manufacturing costs, possibly resulting in lower drug prices for consumers, and can allow more products to be developed. Continuous manufacturing also allows manufacturers to respond much quicker to changes in demand, potentially averting drug shortages. FDA’s approval of JSC’s move to CM marked a significant step towards integrating CM into pharmaceutical production across the industry.

Explanation/Background: 

The drive to replace the existing batch manufacturing process with continuous manufacturing grows out of a five-year collaboration between C-SOPS partners Rutgers University and the University of Puerto Rico, on the one hand, and C-SOPS member companies to develop a process that integrates all manufacturing steps (weighing, milling, blending, compression, and coating) into a single line.

JSC first collaborated with C-SOPS researchers to develop a full-scale continuous manufacturing direct-compression production line at the Center’s Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML), located at Rutgers. The continuous manufacturing line at JSC’s facility in Puerto Rico was then built using that design, as process development work progressed collaboratively at Rutgers. The company’s CM line is currently used for making the HIV-1 drug Prezista. JSC aims to manufacture 70% of its highest-volume products using CM within eight years. 

Another C-SOPS industry partner, Vertex, the maker of a breakthrough cystic fibrosis therapy called Orkambi, has been using the CM process for this drug since it received FDA approval in July 2015. Vertex has the first wet granulator product, manufactured on a production line developed in-house at Vertex using elements of C-SOPS continuous manufacturing technology. JSC’s Prezista, using the Inspire line developed in collaboration with C-SOPS, is the first continuous direct compression product to be approved.  The FDA is strongly encouraging others in the pharmaceutical industry to consider similar efforts to improve quality and technology standards across the industry.