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Newark-based biopharmaceutical institute partnering with FDA for research

The Delaware-based biopharmaceutical manufacturer the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has a new research agreement with the federal Food and Drug Administration (FDA).

The Creative Research and Development Agreement (CRADA) went into effect last month. 

It creates a legal framework for NIIMBL and the FDA to collaborate on biopharmaceutical manufacturing industry training and research in a pre-competitive environment. 

NIIMBL Institute Director and University of Delaware Gore Professor of Chemical Engineering Kelvin Lee says it does not affect the FDA’s role as a regulatory agency.

“One thing it does not do, and this is because of the role the FDA plays in regulating the industry, is it does not address or deal with specific applications from specific company sponsors or specific medicines,” said Lee.

NIIMBL has 120 partners from academia and the public and private sectors. Its new headquarters is set to open at the UD STAR campus next year along with the Delaware Biotechnology Institute, and UD’s biomedical engineering program.

Lee says the new agreement allows for industry-wide collaboration at the new biopharmaceutical building.

“The NIIMBL space will be a neutral 3rd party space, if you will, where various members of our ecosystem can come together and work collaboratively on these projects to advance the technologies, to advance workforce training activities,” he said.

Lee says NIIMBL has about 60 biopharmaceutical manufacturing projects underway. These include methods to simplify the process for sterilizing medication and advancing technologies for manufacturing cell therapies and gene therapies.

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