New NC State-led project to focus on the future of biomanufacturing

A new 5-year project led by North Carolina State University will sponsor an international collaborative research and training program in biomanufacturing science and technology.

The effort focuses on the next generation of biopharmaceutical manufacturing - a rapidly evolving industry sector, critical to grant global access to powerful new biotherapeutics for treating a wide range of chronic and potentially lethal diseases. Biotherapeutics are large-molecule drugs produced by engineered organisms - including antibodies, enzymes, insulin and blood-clotting factors - as well as ingredients for gene therapy and regenerative medicine.

The project - "Accelerated Innovation in Manufacturing Biologics (AIM-Bio)" - is funded by the Novo Nordisk Foundation, whose main objective is to "provide a stable basis for the commercial and research activities of Novo Nordisk and support scientific, humanitarian and social purposes." NC State will administer the $27 million AIM-Bio program in collaboration with the Technical University of Denmark (DTU) in Copenhagen. NC State will receive $18 million to carry out its activities, and the remainder will go to DTU.

This proposal 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."

Louis Martin-Vega, dean of NC State's College of Engineering

Ruben Carbonell, Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering at NC State and principal investigator on the grant, said that the project will have significant global impact on improved manufacturing processes for these new drugs. It will also train a new generation of scientists and engineers who will lead the design and execution of the processes used to manufacture them.

"The pharmaceutical industry is at an important crossroad," he said. "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."

AIM-Bio will establish nine new research projects focusing on technologies of critical importance to biopharmaceutical manufacturing, ranging from cell factory engineering to bioreactor design and optimization to purification of biopharmaceutical products.

"The new research efforts developed through this project will have a significant impact on both NC State and DTU," said Stefano Menegatti, assistant professor of chemical and biomolecular engineering at NC State and a co-PI on the project. "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."

Carbonell, who also serves as chief technology officer for the National Institute for Innovation in Manufacturing Biopharmaceuticals, part of the Manufacturing USA Network to enhance the nation's manufacturing-based economy, says NC State's Biomanufacturing Training and Education Center (BTEC) will develop and offer new courses to train the biopharmaceutical workers of tomorrow. BTEC's primary mission is developing a skilled workforce for the biopharmaceutical industry.

NC State and DTU will develop eight new combined lecture and hands-on short courses aimed at industry professionals, focusing on topics that are particularly relevant to the future of biopharmaceutical manufacturing, including biopharmaceutical process development, 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 U.S.

In addition, three high-demand BTEC courses will be transferred to DTU, where they will be taught for both academic and lifelong learning credit.

"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 Gary Gilleskie, director of BTEC and a co-PI on the project. "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."

The project will involve an extensive exchange of faculty, technical staff, graduate students and postdocs between the U.S. and Denmark. An international Biopharma Leaders' Network of experts and an annual Biopharmaceutical Manufacturing Symposium will foster information exchange, which will help ensure the sustainability of this effort through additional grants coming from government sources, foundations, and industry in Europe and the U.S.

Earlier this year, NC State announced another Novo Nordisk Foundation-funded project to improve crop resilience by studying plant interactions with microbes. That six-year project includes three Danish universities and is funded at $30 million, with $8 million coming to NC State.

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