Janssen, Rutgers Expand Continuous Mfg Pact

Janssen has furthered its strategic partnership with the Rutgers University School of Engineering by providing over $6 million to expand ongoing research efforts supporting the company’s introduction of continuous manufacturing techniques for pharmaceuticals. 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.

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 an academic-based research organization dedicated to modernizing pharmaceutical manufacturing of solid oral dose medications. The funding from Janssen represents an 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 a full production-scale continuous direct compression solid oral dosage manufacturing facility, 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, New Jersey, 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.

Since the center’s founding, researchers at Rutgers have worked in collaboration with industry and its partner universities Purdue, the New Jersey Institute of Technology, 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. The Rutgers group has been researching a wide variety of areas, including powder processing and materials properties, process modeling and control, and in-line process analytical technology in order to design and implement robust and reliable manufacturing processes that meet the quality standards of a regulated industry at lower cost.

Source: Rutgers University

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