Over the past 30 years, North Carolina’s abundance of research universities and Research Triangle Park have made the state a leader in biopharmaceutical manufacturing. The regional participation in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) builds on this advantage and helps create jobs in the region and strengthen the pipeline from research to market readiness.
Founded in 2017, NIIMBL is a nationwide consortium dedicated to accelerating innovations that make biopharmaceutical manufacturing faster, safer and cheaper to improve consumer accessibility. The consortium specifically focuses on the manufacture of protein therapies such as antibodies, gene therapies, cell therapies and vaccines.
“I think a lot of researchers don’t normally think about manufacturing and manufacturing-related research,” said Ralph House, UNC representative for NIIMBL and vice chairman of research in the UNC Department of Chemistry. “But there is another dimension in which we can grow as an institution, and I think it would be an upward growth.”
While the efficient manufacture of biopharmaceuticals has always been the goal of NIIMBL, COVID-19 has made this company more important than ever.
“Our goal is to conduct research at the interface between the findings of innovative companies and scientists in the laboratory and the implementation of technology in production,” says Ruben Carbonell, Senior Technology Strategist at NIIMBL and Faculty Member for Chemical and Biomolecular Engineering bio at the North Carolina State University.
Founded with funding from the US Department of Commerce’s National Institute of Standards and Technology, the organization consists of approximately 150 partners ranging from large manufacturing companies to small businesses, academic institutions, and nonprofits like the Bill & Melinda Gates Foundation. Industry partners identify the key needs or problems to focus on and research partners provide the solutions.
“We joined NIIMBL because we want to identify research areas within the UNC that are close to manufacturing and that could benefit from that funding,” said House. “We wanted to use this as a structure to connect these laboratories with the industrial partners.”
One of the goals of NIIMBL is to develop instruments that improve the efficiency of the manufacturing process. This includes tools that can quickly and accurately measure and verify the contents of bioreactors, which are essential for the manufacture of biotherapeutic agents. Biotherapeutics are made from genetically modified, living mammalian and microbial cells and require cell culture media for their development. Historically, these therapeutics were made using batch processing techniques. Think of it like brewing beer – but instead of alcohol, cells produce protein products like antibodies.
Because biotherapeutics are infused into the human body, they are regulated by the FDA. Quality control during their manufacture is of the utmost importance. Producing these therapies with the required properties and optimal yield requires careful monitoring of the nutrients and growth factors within the bioreactor throughout the process. Typically, samples from a bioreactor are sent to a separate facility, where analysis can take weeks, if not months, far too slow for precise control of the bioreactor.
“We’re trying to introduce analytical techniques that are faster and can be done in-line or at-line during manufacture – which will reduce manufacturing time and increase product release rates,” says Carbonell.
Enter Michael Ramsey, Scientific Founder of 908 Devices Inc. (MASS) and Faculty Member of the UNC Department of Chemistry, the UNC Department of Applied Physical Sciences, and the UNC / NCSU Joint Department of Biomedical Engineering.
Building on inventions by the Ramsey Laboratory and supported by NIIMBL funding, 908 Devices launched a product called Rebel in 2019 – the first at-line media analyzer that enables the collection of comprehensive bioreactor data in minutes. The device can be used to quickly monitor culture media for nutrients and supplements to improve product yield and quality.
The Rebel combines two technologies that were invented at the Ramsey Lab; a highly miniaturized mass spectrometer that resulted in the very first commercial handheld mass spectrometer – developed and marketed by 908 Devices – and a microscale separation platform.
“Two very important tools analytical and biological chemists use to characterize and quantify molecules are mass spectrometry and chemical separation technologies,” says Ramsey. “It’s much easier to characterize a mix of materials when you can pull out all the individual parts and look at them individually.”
The Rebel enables pharmaceutical manufacturers to identify nearly three dozen important biochemical reactor components in around five minutes from a location next to the monitored bioreactor. Its simple and automated design allows technicians to use it without a scientific or technical background after a short training period, allowing PhD students and senior technical staff to focus on higher priority tasks.
“So that’s what the NIIMBL project was about – improving the ability of organic producers to make the best possible products,” says Ramsey.
“908 Devices is a perfect example of a breakthrough company that developed the technology the industry needs,” says Carbonell.
Both the University of North Carolina at Chapel Hill and North Carolina State University are members of the NIIMBL. University attendance is sponsored by funding from the North Carolina General Assembly.
“Mike Ramsey’s NIIMBL project is remarkable for the way it interweaves several threads of dedicated research. These were technologies developed by UNC, a very successful startup, and additional industry funding was attracted from large pharmaceutical companies, ”said Don Hobart, UNC Vice Chancellor for Research. “In addition, it is a textbook example of how UNC and NC State can combine our unique institutional strengths to support our state’s economy.”
By participating in the NIIMBL and working with partners such as 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 working with scientific instruments, the UNC’s ongoing research in the fields of gene and cell therapy, data analysis, machine learning and artificial intelligence offers opportunities to get in touch with the NIIMBL as well as with its member industries and institutions.
Ruben Carbonell is a Senior Technology Strategist at NIIMBL. He is also the Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering, Director of the William R. Kenan, Jr. Institute for Engineering, Technology & Science, and a Distinguished Fellow at the Biomanufacturing Training and Education Center at North Carolina State University.
Don Hobart is the UNC’s Vice Chancellor for Research. He organizes and monitors the UNC’s participation in NIIMBL.
Ralph House is the UNC Chapel Hill representative for NIIMBL. He is also the Assistant Chair of Research in the Department of Chemistry at the UNC College of Arts & Sciences.
Michael Ramsey is the scientific founder of 908 Devices. He is also Minnie N. Goldby Distinguished Professor in the Department of Chemistry at UNC College of Arts & Sciences, Affiliate 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 a co-payment from the North Carolina General Assembly.
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