NIIMBL and FDA sign agreement to support innovation in biopharma manufacturing

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. 

“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,” Lee said.

NIIMBL’s new headquarters will open in spring 2020 in the Ammon-Pinizzotto Biopharmaceutical Innovation Center now under construction on UD’s STAR Campus. The center 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.

To learn more about NIIMBL and how to become part of future collaborative projects, visit


NIIMBL is a public-private partnership with the goal of advancing innovation in biopharmaceutical manufacturing. NIIMBL is part of Manufacturing USA®, a network of 14 manufacturing institutes across the country that brings together industry, academia, and the public sector to advance promising research developments, accelerate new products to market, and train tomorrow’s workforce to secure America’s future. NIIMBL is funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina, and the Commonwealth of Massachusetts. The NIIMBL mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.

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