The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the University of Delaware have entered into a research agreement with the Food and Drug Administration (FDA).
The arrangement, which is called a Collaborative Research Development Agreement (CRADA), allows the partners to collaborate in a “pre-competitive environment” to foster innovative biopharmaceutical research.
“We are increasingly seeing the potential for advanced manufacturing innovations that can improve drug quality, help address shortages of medicines, speed time-to-market, and support personalized medicine through technologies including 3D printing and continuous manufacturing,” said Acting FDA Commissioner Ned Sharpless, M.D. “These technologies can also help the U.S. prepare for public health emergencies by rapidly scaling manufacturing capabilities for vaccines and other medical countermeasures. FDA is taking many steps, including this public-private partnership with NIIMBL, to encourage and help realize the potential of advanced manufacturing: issuing guidance on emerging technologies, approving products made with these technologies, and advancing regulatory science.”
Some research focus areas for the collaboration include continuous manufacturing, on-demand manufacturing, and advanced process control technologies.
“Biopharmaceuticals are more challenging to manufacture than traditional pharmaceuticals and NIIMBL seeks to enhance patient access by innovating the biopharmaceutical manufacturing technologies and processes,” said Kelvin Lee, NIIMBL Institute Director. “This CRADA establishes a framework for FDA engagement in NIIMBL projects and initiatives that strengthens the existing NIIMBL-FDA relationship and supports the development of advanced biopharmaceutical manufacturing innovations.”