NIIMBL and FDA Partner in Biopharmaceutical Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware entered into a Collaborative Research and Development Agreement (CRADA) with FDA on July 15, 2019, according to a July 31, 2019 press statement. Through the CRADA, FDA and NIIMBL will have the ability to support investments in regulatory science research and training needed to promote advanced manufacturing innovations in areas such as 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, in the press statement. “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.” Source: NIIMBL