NC State and BTEC, in conjunction with the Technical University of Denmark (DTU) in Copenhagen, is in the middle of the third 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 is providing $27 million in funding for the project, which NC State will manage.
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. The global biopharmaceutical industry is the fastest growing segment of the pharmaceutical sector, and its products are increasingly in demand by a worldwide patient population in need of better access to powerful drugs that can treat, prevent, control, and even cure chronic and fatal diseases. Yet the biopharmaceutical industry is now faced with a dual challenge of reducing costs and increasing production of its high-volume products, as well as developing safe and cost-efficient processes for new products that have no established manufacturing platforms, such as antibody-drug conjugates, bi-specific antibodies, and gene and cell therapies.
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 are developing 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 will be co-developed and 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 will be 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 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 is establishing an international Biopharma Leaders’ Network of experts and 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.
The impact of the program will be truly significant. Society will benefit as new technologies are implemented that will reduce the cost and increase the effectiveness, safety and accessibility of new biopharmaceutical products. DTU will establish new avenues of investigation and education based on biopharmaceutical products, and NC State will greatly increase its portfolio of short courses and its knowledge base in the areas of industrial biotechnology and sustainability. More importantly, this program will create a lasting bond for international collaborations that will enable both DTU and NC State to pursue future granting opportunities in biopharmaceutical manufacturing, which will ensure the sustainability of this effort for the benefit of the universities, the two nations, the global biopharmaceutical community and society at large.
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. AIM-Bio held a very successful second Annual Symposium on Biopharmaceutical Manufacturing from October 4-6, featuring distinguished speakers from its Biopharma Leaders Network. Discussions are underway with the Novo Nordisk Foundation and NC State University on potential future expansions of this program.