ith a mission 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, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), based at the University of Delaware in Newark, is part of Manufacturing USA, a network of 14 manufacturing institutes across the country. Funded through a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce, NIIMBL leverages additional support from industry, academic institutions, non-profit organizations, and the states of Delaware, Maryland, North Carolina and the Commonwealth of Massachusetts.
NIIMBL in early 2020 will move into a new HQ on the University of Delaware campus. Among the facilities resources shared across NIIMBL’s 100-plus members are:
Among NIIMBL’s 43 technology and workforce development projects valued at $44 million is the Partnership for Workforce Development in the Biopharmaceutical Industry, comprising representatives from the University of North Carolina Wilmington, Alcami Corporation, Cape Fear Community College and Brunswick Community College. The curriculum emphasizes GMP, quality and risk analysis, and advanced manufacturing technologies. A cohort of 16 students completed the initial course and moved on to the lab portion of the curriculum in spring 2019.
In another North Carolina project focused on gene therapy, North Carolina State University, Sudhin Biopharma Co., and the University of North Carolina Chapel Hill are developing a platform process for the production, purification, and analysis of adenoassociated virus (AAV) vectors, the delivery vehicle for DNA into a patient’s cells. After the Biomanufacturing Education and Training Center (BTEC) at North Carolina State opened registration, high demand for the first course scheduled for May 2019 led to the scheduling of a second session in August 2019.
Pilots are one thing. A platform for action is another. In late July, the University of Delaware, on behalf of NIIMBL, entered into a Collaborative Research and Development Agreement (CRADA) with the Food and Drug Administration (FDA). 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 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.”