Rutgers University Research Center and Janssen Develop Continuous Manufacturing Process - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Rutgers University Research Center and Janssen Develop Continuous Manufacturing Process



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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges

Click here