The U.S. Food and Drug Administration (FDA) has awarded $4.9 million in grant funding to institutions in a research consortium based at the Rutgers University School of Engineering to support the introduction of continuous manufacturing techniques for pharmaceuticals.
The research grants, administered by the National Institutes of Health (NIH), will increase research and development efforts at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) over the next 3 years. The Center is helping pharmaceutical companies and the FDA develop systems and regulations for continuous manufacturing, a major innovation in the industry.
"We are very pleased to announce the awarding of these grants, which we believe further demonstrate that the FDA and the pharmaceutical industry consider C-SOPS as leaders in advanced pharmaceutical manufacturing, well positioned to provide expertise and support," said Fernando J. Muzzio, director, National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems. "Continuous manufacturing represents a key component of advanced pharmaceutical manufacturing and will produce significant improvements in quality, safety, efficiency, cost and speed to market. We hope to continue to broaden our collaborations globally in order to continue serving the scientific community, the pharmaceutical industry and regulatory agencies."
Research teams at Rutgers University, the C-SOPS lead institution, and Purdue University, one of the C-SOPS partner institutions, received $4 million to focus on the implementation of continuous manufacturing systems that are equipped with control systems capable of handling raw material variability and assuring product quality in real time, with the funding provided by FDA.
New Jersey Institute of Technology (NJIT), another one of the C-SOPS partner institutions, received $900K in funding to support the development of regulatory science for continuous manufacturing of strip-film based drug dosage forms capable of real-time release. Biocompatible polymer films, the size of a postage stamp that dissolve on or under the tongue, are now seen as a promising alternative to traditional tablets due to their enhanced flexibility and improved patient compliance. "We are excited that an ERC platform technology employing particle engineering to deliver poorly water soluble drugs is supported by FDA and we are looking forward to developing knowhow to achieve quality by design for this inherently continuous manufacturing platform," said Rajesh N. Davé, project leader and NJIT site-leader.
The grants from the FDA are the latest in a series of initiatives that highlight the important role that the Rutgers School of Engineering and C-SOPS are playing in the transformation of manufacturing processes in the pharmaceutical industry.
Earlier this year, FDA officials asked C-SOPS to convene an industrial group to develop a proposal for regulations that would govern the introduction and expansion of continuous manufacturing techniques for the pharmaceutical industry. The invitation by the FDA was issued by Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research and a leading advocate for the manufacturing change, during remarks at a recent industry conference on advanced pharmaceutical manufacturing held at Rutgers University. The FDA has also provided C-SOPS a $500,000 grant to develop capabilities for using C-SOPS process models for process-risk assessment.
Separately, C-SOPS recently received almost $800K from the National Science Foundation (NSF) for an Accelerating Innovation Research Alliance project to establish an industry/academic innovation ecosystem for the development and commercialization of pharmaceutical process modeling for continuous manufacturing.
NSF also funded C-SOPS almost half a million dollars in US-Ireland R&D Partnership in continuous manufacturing for nano-based drug products.
"We believe the latest FDA grant combined with these other initiatives signals the paradigm shift that is taking place within pharmaceutical manufacturing and the critical role that Rutgers and the C-SOPS consortium is playing," Muzzio said. "The significant support of these initiatives demonstrates that our consortium and our researchers are pioneering an innovative approach that is valuable and transformative to the industry."
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