FDA provides grant for pharmaceutical manufacturing


Several different processes are involved in the creation of pills like Advil, which are manufactured in batches. The U.S. Food and Drug Administration (FDA) recently awarded Rutgers' Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) $4.9 million in grants to speed up pill creation through continuous manufacturing.

According to C-SOPS' website, they are currently conducting research on continuous manufacturing in the pharmaceutical industry, which is a major innovation. C-SOPS will use the grant money to help their research and development over the next three years.

This grant follows an invitation earlier this year by Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, for Rutgers to assemble an industrial consortium to develop a proposal for regulating continuous manufacturing, according to their website.

Douglas Hausner, industrial liaison for C-SOPS, said the grant's purpose is to help advance the FDA's understanding of how to regulate continuous manufacturing. 

“The pharmaceutical industry is going through a transition where they’re moving from batch manufacturing to continuous manufacturing," he said.

According to the Parental Drug Association, continuous manufacturing differs from more traditional batch manufacturing by creating an assembly line for the tablets. Rather than create a large number at once, pills are created constantly, which overall takes less time than through batches.

Specifically, the grant to Rutgers is to develop continuous manufacturing systems with proper control systems. According to C-SOPS' website, these control systems must be capable of “handling raw material variability and assuring product quality in real time.”

Rutgers has been highly involved in this transition, Hausner said. The University has been helping the FDA as the agency tries to figure out how to regulate this new type of manufacturing.

The grant was specifically awarded to Rutgers because it is a leader in this area of research. C-SOPS is the world’s largest academic industrial research effort for pharmaceutical manufacturing, he said.

C-SOPS is an industrial consortium that involves 50 companies and three other universities. The group also has a full-scale manufacturing plant in the School of Engineering on Busch campus. 

The Engineering Research Center built a track record over the last several years through different, smaller projects, he said. This helped it earn the latest grant.

Rutgers is specifically working on the continuous manufacturing of capsules and tablets. According to the official C-SOPS updates publication, their focus over the past few years has been Continuous Solid Oral Dosage Manufacturing.

Other members of the consortium have different focuses, he said. For example, the NJIT branch is working on strip film technology, which is used in Listerine breath strips.

C-SOPS’ work in continuous manufacturing is now beginning to see successful implementations in the pharmaceutical industry. The official C-SOPS update states that they are starting to see the “first approvals for products using this manufacturing approach, and the interest has never been greater.”

The research at Rutgers has benefited the pharmaceutical industry, Hausner said.

C-SOPS has received high levels of funding from Janssen Pharmaceuticals to help develop their products with the technologies being researched, he said. The partnership between Rutgers and pharmaceutical companies has brought great advantages to all parties.

"The advantages to the University and the companies have been great in terms of academic partnership between the two," he said.


George Xie

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