Effective July 15, 2019, the FDA and NIIMBL will have the ability to collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharmaceutical manufacturing industry. This CRADA will enable 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.
"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."
Kelvin Lee, NIIMBL Institute Director, said, "Biopharmaceuticals are more challenging to manufacture than traditional pharmaceuticals and NIIMBL seeks to enhance patient access by innovating the biopharmaceutical manufacturing technologies and processes. 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."