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Jennifer Markarian is manufacturing editor of BioPharm International.
Rutgers engineers constructed a direct compaction line in collaboration with Janssen.
Researchers in the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers, the State University of New Jersey, have collaborated with Janssen to develop a direct-compaction line using continuous manufacturing principles. C-SOPS researchers built a full-scale production line at the Rutgers to test concepts and define a design space. Janssen is now constructing a line based on that design, which is targeted for completion in 2014.
C-SOPS, based on the Rutgers University campus and in partnership with Purdue University, The New Jersey Institue of Technology, and The University of Puerto Rico at Mayagüez, brings together a cross-disciplinary group of engineers, scientists, and industry leaders from academia, pharmaceutical manufacturers, and equipment manufacturers. C-SOPS has been investigating continuous manufacturing concepts since 2006 and has worked on both the fundamental science and commercialization of advanced pharmaceutical manufacturing. The continuous direct compaction line replaces the traditional multi-stage batch process by integrating feeders, mills, blenders, and a tablet press into a single continuous process.
In developing the line, C-SOPS researchers defined parameters and performed design space experiments to evaluate the effect of parameter changes. “Because the process is continuous, we were able to measure parameter-change effects in nearly real time; we performed a full set of design experiments with dozens of conditions, in hours rather than days to weeks, and used a fraction of the API needed for batch processing,” explains Douglas Hausner, associate director for industrial relations and business development at C-SOPS.