Janssen Expands Partnership with Rutgers for Continuous Manufacturing Research

Janssen Supply Chain furthered its strategic partnership with the Rutgers University School of Engineering by providing over $6 million to expand ongoing research efforts supporting Janssen's introduction of continuous manufacturing techniques for pharmaceuticals, the company said in a May 18, 2015 joint press release with Rutgers. The funds from Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, will increase research and development efforts at the Rutgers Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) over the next several years. The center is helping Janssen transition several products to continuous manufacturing, including developing a specially designed manufacturing line at a Janssen facility in Puerto Rico.

"Continuous manufacturing represents the future of advanced pharmaceutical manufacturing and will produce significant improvements in efficiency, safety, cost, and speed to market. Our center is now better positioned than ever to serve the scientific community, the pharmaceutical industry and the regulatory agencies," said Fernando J. Muzzio, director, National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems (ERC-SOPS) and professor, chemical and biochemical engineering, in the press release.

The Rutgers ERC, established nine years ago with funding from the National Science Foundation and a consortium of more than 40 companies within the pharmaceutical sector, is dedicated to modernizing pharmaceutical manufacturing of solid oral-dose medications. The funding from Janssen represents a significant expansion of an arrangement that began five years ago and that focuses on technical development of continuous processing, an emerging advanced pharmaceutical manufacturing method.

As part of this collaboration, Rutgers engineers designed and built one of the first full production-scale continuous direct compression solid oral-dosage manufacturing facilities, which was used as the model for the Janssen production line in Puerto Rico and is also being used as a model by other pharmaceutical manufacturers. This direct compression tableting line, located at the engineering school campus in Piscataway, has now been expanded to also include wet and dry granulated products and can accommodate tests of multiple production routes under automated control for optimal product and process design.

Continuous manufacturing offers a number of significant benefits, and over time, is likely to replace conventional batch processing for many products. The pharmaceutical industry has been slow to adopt this technology, which is the standard in many other industries. However, in recent years the pace has accelerated following explicit support from the FDA for these processes.

Since the center's founding, researchers at Rutgers have worked in collaboration with industry and its partner universities Purdue, NJIT, and the University of Puerto Rico to develop an understanding of the science that goes into designing and operating continuous pharmaceutical manufacturing systems for solid oral dosage forms.

Source: Rutgers