NC State and BTEC, in conjunction with the Technical University of Denmark (DTU) in Copenhagen, is in the middle of the fourth year of a five-year international collaborative research and training program in biomanufacturing science and technology, funded by the Novo Nordisk Foundation. The Accelerated Innovation in Manufacturing Biologics (AIM-Bio) project has established 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 provided $27 million in funding for the project, which NC State manages. KIETS Director Ruben Carbonell and Gary Gilleskie, executive director of BTEC, serve as principal investigators for the grant. NC State will receive $18 million to achieve its activities, and the remainder will go to DTU. This program brings together two academic institutions with complementary areas of experience and expertise to create an international collaborative enterprise engaged in education, lifelong learning, and process research and development to address the future needs of the biopharmaceutical industry.
NC State and DTU developed eight new combined lecture and hands-on short courses aimed at 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. Four of these courses are taught by faculty members and staff at both DTU and NC State and offered to students and industry professionals from both Denmark and the US. In addition, three BTEC courses that are in very high demand by industry were transferred to DTU, so they can be taught in Denmark for both academic and lifelong learning credit.
The program has also established 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 students, and postdoctoral students from both DTU and NC State to make the best use of each institution’s strengths, infrastructure, and capabilities. Among the topics being investigated: 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.
To weave this ambitious program into the fabric of both institutions, DTU and NC State, and promote continued synergism between them, the AIM-Bio program has established an External Advisory Board of industry and academic leaders in biopharmaceutical manufacturing. It also established an annual Biopharmaceutical Manufacturing Symposium to foster the development of new knowledge that will ultimately lead to funding sources to ensure the sustainability of this collaborative effort.
Preparations are underway for a new proposal to the NNF, that would continue the program from 2025 to 2030. A preliminary proposal is under consideration focused on biologics manufacturing technologies that can be extended to bioindustrial applications, and are sustainable, so they can help reduce global CO2 emissions. In the meantime, the current grant has been extended through 2025, and the NNF has shown clear interest in renewing funding after this period. It should be noted that several technologies created with NNF funding have reached the point of commercialization.