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 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. 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 following accomplishments demonstrate the impact of the program to date:
- 250 professionals (from both the U.S. and Europe) and graduate students (at NC State and DTU) have received training in courses designed by the AIM-Bio professional development program.
- Seven new courses have been developed and delivered at NC State with one more in development.
- Six courses have been transferred and delivered at DTU.
- Nine research projects are underway that are working with industry to translate results.
- 16 student exchanges and three faculty/staff are in progress or complete.
- Three annual symposium meetings have been held.
In the AIM-Bio research program, several new scientific discoveries and demonstrations have been made in the areas of Cell Engineering, Process Analytical Technologies and Single-use Devices. The PIs also reported 45 publications generated, seven patents filed or granted, 24 faculty members involved, 13 graduate students, five post docs, and 23 companies engaged.