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Major Step for Biopharma Research

NIIMBL and FDA sign agreement to support innovation in biopharma manufacturing

by | August 1, 2019

Photo courtesy of Smith Group
Ammon Pinizzotto Biopharmaceutical Innovation Center Building

The Ammon-Pinizzotto Biopharmaceutical Innovation Center now under construction on UD’s STAR Campus will house NIIMBL, the Delaware Biotechnology Institute, and UD’s biomedical engineering program, as well as research laboratories in pharmaceutical discovery and molecular and medical sciences.

The University of Delaware has entered into a Collaborative Research and Development Agreement with the U.S. Food and Drug Administration on behalf of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Part of the Manufacturing USA network, the institute has more than 120 partners, including private companies, academic institutions and nonprofits, and will open headquarters in 2020 at UD’s Science, Technology and Advanced Research (STAR) Campus. 

According to the agreement, known as a CRADA, effective July 15, 2019, the FDA and NIIMBL have the ability to collaborate in a pre-competitive environment to strengthen research, innovation, training and collaboration in the biopharmaceutical manufacturing industry. 

“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 Dr. Ned Sharpless. 

“These technologies can also help the U.S. prepare for public health emergencies by rapidly scaling manufacturing capabilities for vaccines and other medical countermeasures. The 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,” Sharpless said.

UD’s signatory to the agreement, Charlie Riordan, vice president for research, scholarship and innovation, said, “This is a major step forward that will enhance biopharmaceutical research and the development needed to bring these revolutionary medicines to market. Our University of Delaware research community joins the many NIIMBL partners around the nation who are cheering on this new partnership that ultimately will help patients in need.” 

The CRADA will enable the FDA and NIIMBL to support investments in regulatory science research and training needed to foster advanced manufacturing innovations in areas such as continuous manufacturing, on-demand manufacturing and advanced process control technologies, among others. Ultimately, advancements in these areas will help increase NIIMBL’s national impact by enhancing patient access to new and improved medicines.

“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 director and Gore Professor of Chemical and Biomolecular Engineering at UD.