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North Carolina Poised for Prime Role in Biomanufacturing Consortium

By Barry Teater, NCBiotech Writer

A new National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will have a strong North Carolina flavor when it starts work in March 2017.

“North Carolina is one of the leading states in biopharmaceutical manufacturing, and we will play a key role in NIIMBL efforts,” said Ruben G. Carbonell, Ph.D., a professor at N.C. State University (NCSU) who will be the consortium’s chief technology officer. “This is a fantastic opportunity for North Carolina.

- BTEC Photo

North Carolina participants will include NCSU, UNC-Wilmington, UNC-Charlotte, UNC-Chapel Hill, N.C. Central University, East Carolina University, the N.C. Community College System, the Golden LEAF Biomanufacturing Training and Education Center (BTEC), the N.C. Biosciences Organization (NCBIO), and the N.C. Biotechnology Center. Numerous companies with facilities in North Carolina, including Pfizer, Grifols, Biogen and Novo Nordisk, will also be members, Carbonell said.

The national consortium will start with 150 members in 25 states and will add more, said Penny Pritzker, secretary of the U.S. Department of Commerce, who announced the consortium on Dec. 16. NIIMBL will be funded over five years with $70 million from the National Institute for Standards and Technology (NIST) and at least $129 million in matching funds from state governments, universities, community colleges and companies.

NIIMBL is part of the federal government’s Manufacturing USA network, intended to spur academic and company collaborations that will take industry-relevant technologies from the laboratory to the market in the next five to seven years. The network has nine institutes, and six more, including NIIMBL, will be added in 2017.

The Obama administration launched Manufacturing USA in 2012 to encourage a stronger, more agile American manufacturing sector. The network will have 1,450 members with the addition of NIIMBL.

NIIMBL was created to help overcome particular challenges faced by manufacturers of biological drugs.

Biologics are more complex to manufacture than traditional drugs, and their manufacturing processes are subject to regulation by the U.S. Food and Drug Administration. Making changes and improvements to the manufacturing process requires re-review by the FDA, which is time consuming and expensive.

NIIMBL “will spread the risks and share the benefits across the industry of developing and gaining approval for innovative processes,” Pritzker said.

“For existing products, this opens the door to increasing the speed and flexibility in the manufacturing process,” she said. “For new products, the innovations created here will make it easier for industry to scale up production and provide the most ground-breaking new therapies to more patients sooner.”

For example, Pritzker cited a public health crisis such as a new strain of the flu.

“We can innovate and produce life-saving solutions more quickly,” she said. “The ability to take a new formula to scale is particularly important since most biopharmaceutical products have a shortened shelf life, which means we cannot easily stockpile them in anticipation of a crisis.”

NIIMBL will also encourage industry and academia to close the growing job-skills gap facing biopharmaceutical manufacturers.

“Jobs in biopharmaceuticals pay twice as much as the national average,” Pritzker said, “but companies often struggle to find skilled workers to make these next-generation drugs.”

NIIMBL will work with community colleges and universities across the country to develop curricula, internships and faculty sabbaticals that meet the technical

demands of biopharmaceutical manufacturers. It will also implement education programs in science, technology, engineering and math at the K-12 level to prepare a biomanufacturing workforce.

Carbonell said BTEC will play a key role in workforce development, including academic and industry training programs, as well as process and analytical services and research.  Located on NCSU’s Centennial Campus, BTEC provides hands-on learning using equipment, facilities and technologies like those used by commercial biomanufacturers.

NIIMBL is the first institute in the Manufacturing USA network to be led by the Commerce Department. It was created following an open competition for proposals.

Carbonell was one of the NIIMBL proposal’s main authors. He is a Frank Hawkins Kenan Distinguished Professor, director of the William R. Kenan, Jr. Institute for Engineering, Technology and Science, and director of BTEC at NCSU.

He said more than 30 faculty members at NCSU have expressed interest in participating in NIIMBL-sponsored research.

 

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