Pallone & FDA Commissioner Gottlieb Visit Rutgers University to Discuss Innovative Pharmaceutical Manufacturing
During Tour Pallone Announced Introduction of Legislation to Expand Innovative Research Partnerships between FDA and Universities
Today, Congressman Frank Pallone, Jr. (NJ-06) and Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. visited Rutgers University together to tour the campus' Center for Structured Organic Particulate Systems (C-SOPS). Pallone invited Commissioner Gottlieb to Rutgers to discuss the university center's leading role in the advancement of innovative technology known as continuous manufacturing, which could revolutionize the development of pharmaceutical products.
Drug manufacturing has changed very little in 50 years with the majority of companies still using "batch" manufacturing techniques that can be inefficient, slow, and may be subject to the risk of defects or errors during the manufacturing process. Continuous manufacturing is an emerging technology whereby a finished product is produced in a continuous stream. The pioneering technology allows product quality to be precisely controlled, reduces challenges in scaling up production, can more readily produce ranges of drug strengths and doses, and requires less physical space. This could allow production sites to be located closer to the U.S., reducing the need for transcontinental shipping.
"I am grateful to my fellow New Jerseyan Commissioner Gottlieb for joining me at Rutgers University today to discuss the exciting, cutting-edge innovation taking place right here in our backyard," Congressman Pallone said. "Rutgers is playing a key role in the development of continuous manufacturing techniques that I hope will result in safer and cheaper medicine."
"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," said Rutgers-New Brunswick Chancellor Deba Dutta.
During today's visit, Pallone announced the introduction of the National Centers of Excellence in Continuous Manufacturing Act of 2018. The legislation would allow FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing. The designated universities would work with FDA and industry to further develop and implement continuous manufacturing technology. Pallone's legislation would authorize $80 million in funding to support this effort.
"This legislation will expand opportunities for 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 continued.
Rutgers' C-SOPS has been in place for over a decade and has designed and implemented continuous manufacturing methods for powder-based pharmaceutical products. The center includes a two-story, state-of-the-art lab including a full-scale production line built with funding from National Science Foundation and industry. The center is working side-by-side with industry to integrate continuous manufacturing into commercial production. In addition, the lab provides opportunities for students to participate in projects that will prepare them for careers as industry leaders of the future.
Pallone authored legislation that was signed into law in 2016 as a part of 21st Century Cures Act authorizing FDA to issue grants to institutions of higher education and nonprofit organizations to study and make recommendations regarding improvements to the process of continuous manufacturing of drugs and biologics. Pallone is the Ranking Democrat of the House Energy and Commerce Committee, which oversees the FDA.
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