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A female student in a lab coat works with a device that has a scren on it in a lab setting.For the past 30 years, North Carolina’s abundance of research universities and the Research Triangle Park has made the state a powerhouse in biopharmaceutical manufacturing. Regional participation in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) builds upon that asset, helping bring jobs to the area and strengthening the research-to-market pipeline.

Launched in 2017, NIIMBL is a nation-wide consortium aimed at accelerating innovations that make biopharmaceutical manufacturing faster, safer, and at lower cost in order to increase accessibility to consumers. The consortium specifically focuses on the manufacturing of protein therapies like antibodies, gene therapies, cell therapies, and vaccines.

“I think a lot of researchers don’t typically think about manufacturing and manufacturing-related research,” says Ralph House, the UNC representative for NIIMBL and associate chair for research in the UNC Department of Chemistry. “But it’s another dimension that we, as an institution, can grow in and I think it would be upward growth.”

While efficiently manufacturing biopharmaceuticals has always been the goal of NIIMBL, COVID-19 has made this enterprise more important than ever.

“Our goal is to do research that is at the interface between the findings of innovative companies and academics in the laboratory, and the implementation of technology in production,” says Ruben Carbonell, NIIMBL’s senior technology strategist, and faculty member of chemical and biomolecular engineering at North Carolina State University.

Initiated by funding from the U.S. Department of Commerce’s National Institute of Standards and Technology, the organization is made up of about 150 partners ranging from large manufacturing firms to small companies, academic institutions, and non-profits like the Bill & Melinda Gates Foundation. Industry partners identify major needs or problems to focus on, and research partners provide the solutions.

“We joined NIIMBL because we want to identify research areas within UNC that are close to manufacturing that could benefit from this funding,” House says. “We wanted to utilize this as a structure to connect those labs with the industrial partners.”

One of NIIMBL’s objectives is developing instruments that improve the efficiency of the manufacturing process. These include tools that can rapidly and accurately measure and verify the contents of bioreactors, which are essential to making biotherapeutics. Biotherapeutics are produced using genetically modified, live mammalian and microbial cells and require cell culture media for their development. Historically, these therapeutics have been made with batch-processing techniques. Think of it like brewing beer — but instead of alcohol, the cells create protein products like antibodies.

Because biotherapeutics are infused into the human body, they are FDA-regulated. Quality control during their manufacturing is paramount. Producing these therapies with the required characteristics and optimal yield requires careful monitoring of nutrients and growth factors inside the bioreactor during the entire process. Typically, samples from a bioreactor are sent to a separate facility, where analyses could take weeks, if not months – far too slow for precise control of the bioreactor.

“We’re trying introduce analytical techniques that are faster and can be done inline or at-line during manufacturing — decreasing manufacturing time and increasing the rate of product release,” Carbonell says.

Enter Michael Ramsey, scientific founder of 908 Devices Inc. (MASS), and faculty member in the UNC Department of Chemistry, UNC Department of Applied Physical Sciences, and the UNC/NCSU Joint Department of Biomedical Engineering.

Building upon inventions from the Ramsey Laboratory and supported with funding from NIIMBL, 908 Devices released in 2019 a product named the Rebel — the first at-line media analyzer that enables acquisition of comprehensive bioreactor data in minutes. The device can be used to rapidly monitor culture media for nutrients and supplements to improve product yield and quality.

The Rebel combines two technologies invented in the Ramsey Lab; a highly miniaturized mass spectrometer that led to the first ever commercial handheld mass spectrometer — developed and marketed by 908 Devices — and a micro-scaled separations platform.

“Two very important tools analytical and biological chemists use to characterize and quantify molecules are mass spectrometry and chemical separation technologies,” Ramsey says. “It’s much easier to characterize a mixture of materials if you can pull out all the separate components and look at them individually.”

The Rebel allows pharmaceutical manufacturers to identify nearly three dozen important biochemical reactor components in about five minutes from a location adjacent to the bioreactor it monitors. It’s simple and automated design enables technicians to use it after a short training period with no scientific or technical background, freeing up PhDs and senior technical staff to focus on higher-priority tasks.

“So that’s what the NIIMBL project was about — advancing the abilities of biomanufacturers to produce the best products possible,” Ramsey says.

“908 Devices is a perfect example of a pioneering company that has developed a technology that the industry needs,” Carbonell says.

Both the University of North Carolina at Chapel Hill and North Carolina State University are members of NIIMBL. University participation is encouraged by matching funds provided by the North Carolina General Assembly.

“Mike Ramsey’s NIIMBL project has been remarkable for the way it weaves together multiple threads of engaged research. It involved technology developed at UNC, a highly successful startup company, and it attracted additional industry funding from major pharmaceutical companies,” says Don Hobart, UNC’s associate vice chancellor for research. “On top of that, it’s a textbook example of how UNC and NC State can combine our unique institutional strengths to support our state’s economy.”

Through participation in NIIMBL and engagement with partners like NC State’s Biomanufacturing Training and Education Center (BTEC), UNC aims to continue developing technologies and innovations that meet the needs of North Carolina’s biopharmaceutical industry. In addition to work involving scientific instrumentation, UNC’s ongoing research in gene and cell therapy, data analytics, machine learning, and artificial intelligence provides opportunities to engage with both NIIMBL and its member industries and institutions.

 

Ruben Carbonell is senior technology strategist at NIIMBL. He is also the Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering, the director of the William R. Kenan, Jr. Institute for Engineering, Technology & Science, and Distinguished Fellow at the Biomanufacturing Training and Education Center at North Carolina State University.

Don Hobart is an associate vice chancellor for research at UNC. He organized and oversees UNC’s participation in NIIMBL.

Ralph House is NIIMBL’s UNC-Chapel Hill representative. He is also the associate chair for research in the Department of Chemistry within the UNC College of Arts & Sciences.

Michael Ramsey is the scientific founder of 908 Devices. He is also the Minnie N. Goldby Distinguished Professor in the Department of Chemistry within the UNC College of Arts & Sciences, affiliated faculty in the Department of Applied Physical Sciences, and professor of biomedical engineering in the UNC/NCSU Joint Department of Biomedical Engineering.

Ramsey’s project was sponsored by NIIMBL, with additional industry funding from Bristol-Myers Squibb (Celgene), MilliporeSigma, and 908 Devices, and cost-share funding provided by the North Carolina General Assembly.

By Megan May, Endeavors
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