New Institute Aims to Help Bring Cell-based Medicines to Market

The Georgia Institute of Technology will play a key role in a new federally backed initiative to advance medications made from cells, such as vaccines and autoimmune drugs, as well as therapies using living cells to treat a range of conditions.

More than 150 companies, academic institutions and other organizations are taking part in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), which the U.S. Department of Commerce is supporting with a five-year, $70 million grant. The consortium aims to improve the way biological medicines, also known as biopharmaceuticals, are produced, with a goal of bringing down costs and finding ways to get the drugs into the hands of clinicians and patients faster.

“Georgia Tech is very well positioned for this effort,” said Andreas Bommarius, a professor in the School of Chemical and Biomolecular Engineering, who is leading Georgia Tech’s participation with the new institute. “Our expertise in process development and modeling, scaling up those processes, and applying sensor technology offers a complete set of the skills required to help advance this initiative. In addition, our experience working closely with industry keeps us in tune with what will work in real market conditions.”

Compared to traditional pharmaceuticals, which are made primarily through chemical processes, biopharmaceuticals are much more challenging to produce. With medicines made from cell-based processes, finding ways to produce larger quantities at a time is a key challenge. For cell therapies, challenges range from developing consistent manufacturing processes to scaling up production of a living entity.

“Medicines are not coming onto the market fast enough, and price is a big issue,” Bommarius said.

The initiative, which is being coordinated by the University of Delaware in partnership with the National Institute of Standards and Technology (NIST), will also start with a private investment of at least $129 million from institute members across the country in addition to the federal funding.

“The institute announced today is a resource that will spread the risks and share the benefits across the biopharmaceutical industry of developing and gaining approval for innovative processes,” U.S. Secretary of Commerce Penny Pritzker said at the announcement of the new institute on December 16. “The innovations created here will make it easier for industry to scale up production and provide the most groundbreaking new therapies to more patients sooner.”

Krishnendu Roy, Robert A. Milton Chair and professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, said the new institute is a major step forward in the effort to develop cell-based therapies.

“The federal government is now co-investing with industry on biopharmaceuticals, which will mean therapies are brought to patients faster,” Roy said. “It gives us that much more bandwidth to make investments and brings in additional resources and additional opportunities.”

Roy is also spearheading a separate initiative aimed at advancing cell manufacturing technology: the National Cell Manufacturing Consortium, which Georgia Tech is leading along with the Georgia Research Alliance. Last January, Georgia Tech also announced a research center devoted to developing processes and techniques to manufacture living cells — the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), made possible by a $15.7 million grant from the Atlanta-based Marcus Foundation. This center will work closely with NIIMBL to further leverage the unique private-public partnership and develop transformative technologies to bring cell-based therapies to clinic faster and at a lower cost.

Another key component of the new biopharmaceutical initiative is workforce training — looking for ways to create a pipeline of workers with skills necessary for biopharmaceutical production and boosting economic development in states with those resources.

“Availability of a well-trained and skilled workforce is key to the success of the biopharmaceutical manufacturing industry, and there is currently a significant shortage of such skilled workers,” Roy said. “Georgia Tech will play a key role in developing this workforce, within Georgia and in the U.S., thereby adding new jobs and helping to improve the economy.”

The consortium is establishing a new nonprofit organization called USA Bio LLC to administer the cooperative agreement with NIST. Initial work in the months ahead will focus on identifying specific projects to help advance medical therapies that are already past the point of concept but still far from being brought to market.