FDA Commissioner Sees Innovative Pharmaceutical Manufacturing in Action at Rutgers

FDA Commissioner Sees Innovative Pharmaceutical Manufacturing in Action at Rutgers

During visit, Congressman Frank Pallone Jr. announces legislation to expand innovative research partnerships between FDA and universities

FDA commissioner Scott Gottlieb (left), Congressman Frank Pallone Jr. and N.J. labor commissioner Robert Asaro-Angelo (right) get a tour of the Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers-New Brunswick from center director Fernando Muzzio.
Mel Evans/Rutgers University

“This legislation will expand opportunities for the FDA to partner with universities like Rutgers and industry to collaborate on a national framework for the adoption of continuous manufacturing while building a 21st-century workforce here at home."
 
– Congressman Frank Pallone Jr.

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Food and Drug Administration commissioner Scott Gottlieb grew up in East Brunswick and spent many weekend days at Rutgers, attending football games and other events.  On Monday, he returned to tour the Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers-New Brunswick to discuss its leading role in the advancement of innovative technology in pharmaceutical production.

The center brings together engineers, scientists and industry leaders to improve the manufacturing of pharmaceuticals. Rutgers’ C-SOPS has designed and implemented continuous manufacturing methods for powder-based pharmaceutical products, a technology that enables much faster production of more reliable products through an uninterrupted process.

“I’ve had many conversations about this technology, but this is the first time I’ve seen this technology in action,” Gottlieb said. In responding to audience questions, the FDA commissioner indicated strong FDA support for the implementation of continuous manufacturing methods, which he said offer many advantages for the efficient and effective manufacturing of pharmaceutical products.

The FDA commissioner toured the Rutgers’ facility at the invitation of Congressman Frank Pallone Jr.  During remarks provided to university and industry leaders, Pallone announced the introduction of his legislation, the National Centers of Excellence in Continuous Manufacturing Act of 2018.

The legislation would allow the FDA to partner with universities across the country, after designating them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, to further develop and implement continuous technology. Pallone’s legislation would authorize $80 million in funding to support this effort.

“This legislation will expand opportunities for the FDA to partner with universities like Rutgers and industry to collaborate on a national framework for the adoption of continuous manufacturing while building a 21st-century workforce here at home,” Pallone said. “The idea is to promote continuous manufacturing and public-private partnerships, which Rutgers is so good at.”

Following the announcement, Rutgers-New Brunswick chancellor Deba Dutta said “Rutgers is thrilled to be recognized for our critical leadership in continuous pharmaceutical manufacturing and for our commitment to public-private partnerships that bring innovation and economic development to New Jersey.”

The FDA’s Gottlieb said continuous manufacturing platforms can bring more pharmaceutical manufacturing back to the U.S., help lower drug and device development costs and reduce the risk of shortages.

Robert Asaro-Angelo, commissioner of the N.J. Department of Labor & Workforce Development, also joined the tour of the center, which is led by director Fernando Muzzio, Distinguished Professor of Chemical and Biochemical Engineering.

During his presentation, Muzzio proposed to create an FDA-sponsored Center for Advanced Pharmaceutical Manufacturing to ensure continuity in FDA global leadership. Muzzio said science-based regulation of continuous processes, enabling continuous innovation, is essential to bring back pharmaceutical manufacturing to the U.S. “The key to winning is not to be cheaper,” he said. “It is to be better.”

Founded in 2006, C-SOPS brings together a cross-disciplinary team of researchers from major universities to work closely with industry leaders and regulatory authorities to improve the way pharmaceuticals, foods and agriculture products are manufactured. In addition, the center provides opportunities for students to participate in projects that will prepare them for careers as industry leaders of the future.

Headquartered at Rutgers University, C-SOPS partners include the New Jersey Institute of Technology, Purdue University, the University of Puerto Rico at Mayaguez and more than 40 industrial consortium member companies.

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