Transforming Pharmaceutical Biomanufacturing

NC State and the Technical University of Denmark (DTU) in Copenhagen have been awarded a $27 million grant from the Novo Nordisk Foundation to carry out a collaborative program in bioprocess research and development and workforce training that focuses on products and technologies that will transform the future of biopharmaceutical manufacturing.

The Accelerated Innovation in Manufacturing Biologics (AIM-Bio) project will establish a long-term partnership in both research and educational areas between between DTU, the Golden LEAF Biomanufacturing Training and Education Center (BTEC), and researchers from various NCSU disciplines. NC State will manage the project and receive $18 million to achieve its activities, while DTU will receive the remaining $9 million.

Three key members of the project team have strong ties to CBE. Dr. Ruben Carbonell, Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering, is the project’s principal investigator. Drs. Gary Gilleskie (B.S. ’86), acting Director of BTEC, and Stefano Menegatti (Ph.D. ‘2013), Assistant Professor of Chemical and Biomolecular Engineering, are co-principal investigators for the grant. Ruben currently serves as Director of the William R. Kenan, Jr. Institute for Engineering, Technology, & Science, and is the initial Chief Technology Officer for the fledging National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). He’s currently on leave from his position of Director of BTEC.

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.”

“The new research efforts developed through this project will have a significant impact on both NC State and DTU,” said Dr. Menegatti. “They are particularly exciting since they address some of the major needs of the international bioprocess industry and involve multidisciplinary collaborations with researchers with various backgrounds from both universities.”

Key features of the AIM-Bio project include:

• 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, students and postdoctoral researchers 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; membranes 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.

  “These eight new short courses represent a 40% increase in the number of courses that BTEC will be able to provide to professionals in industry,” said Dr. Gilleskie. “Many of these individuals are from local companies, but BTEC also serves a broader national audience with its professional development courses. The collaboration with DTU will be an important milestone for BTEC as now we will establish a wider international footprint.”

• Creating an international collaboration and exchange program that will provide for the exchange of investigators, technical staff, students, and postdoctoral scholars 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.

This article includes content from news articles on the BTEC and NC State College of Engineering web sites.