New $27 million AIM-Bio project to advance biopharmaceutical manufacturing
Published August 30, 2019
NC State and BTEC, in conjunction with the Technical University of Denmark (DTU) in Copenhagen, will carry out a new five-year project focused on an international collaborative research and training program in biomanufacturing science and technology. The Accelerated Innovation in Manufacturing Biologics (AIM-Bio) project will establish a world-class program in bioprocess research and development and workforce training that focuses on products and technologies for the future of biopharmaceutical manufacturing. The Novo Nordisk Foundation recently announced it will provide $27 million in funding for the project, which NC State will manage. NC State will receive $18 million to achieve its activities, and the remainder will go to DTU.
Ruben Carbonell, Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering at NC State, and Gary Gilleskie, executive director of BTEC, serve as principal investigators for the grant. According to Dr. Carbonell, “The pharmaceutical industry is at an important crossroad. While industry focuses on increasing production of high-volume products, such as antibodies, while cutting costs, it must also develop safe and cost-efficient processes for new biological products that have no established manufacturing platforms, such as gene and cell therapies. We believe this program can provide some solutions while addressing the future of the biopharmaceutical industry.”
Key features of the AIM-Bio project include the following:
- Carrying out nine new research projects focusing on technologies of critical importance to biopharmaceutical manufacturing, ranging from cell factory engineering to upstream bioreactor design and optimization, to downstream capture and purification operations. Each project will involve tasks executed by investigators, graduate and postdoctoral students from both DTU and NC State to make the best use of each institution’s strengths, infrastructure and capabilities.
Topics to be investigated include novel yeast cell therapeutic modalities; high productivity perfusion bioreactor systems; automation and high-throughput fermentation; specific ligands for affinity purification of next-generation protein therapeutics; membrane and resins enabling continuous manufacturing with single-use devices; biosensors for multiplexed real-time monitoring of critical product quality attributes; and modeling and simulation of bioprocesses.
- Developing and conducting eight new combined lecture and hands-on short courses for industry professionals on topics that are particularly relevant to the future of biopharmaceutical manufacturing, including the manufacturing of vectors for gene and cell therapies, automation and process control, and analytical methods. Several courses will be developed jointly by faculty and staff at both NC State and DTU, and all will be available to students and industry professionals from both Denmark and the U.S.
- Creating an international collaboration and exchange program that will provide for the exchange of investigators, technical staff, graduate students, and postdocs between the U.S. and Denmark. In addition, AIM-Bio will establish an international Biopharma Leaders’ Network of experts and hold an annual Biopharmaceutical Manufacturing Symposium to foster the development of new knowledge.
The Novo Nordisk Foundation is an independent Danish foundation. Its vision is to contribute significantly to research and development that improves the lives of people and the sustainability of society. It also has major ownership stakes in Novo Nordisk and Novozymes. A global healthcare company with more than 95 years of innovation and leadership in diabetes care, Novo Nordisk is headquartered in Denmark, employs approximately 41,600 people in 80 countries, and markets its products in more than 170 countries. In North Carolina, Novo Nordisk operates a major fill-finish facility for insulin and is building a $2 billion facility for active pharmaceutical ingredient manufacture for diabetes products, both in Clayton. In addition, Novozymes manufactures enzymes at its site in Franklinton. Representatives from Novo Nordisk and Novozymes serve on BTEC’s Advisory Board.