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NIIMBL aims to help vaccine developers refine product

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Graduate student Erica Green works in a new NIIMBL lab to continue critical research during COVID-19 restrictions. | PHOTO COURTESY OF UD

NEWARK – More than five dozen companies, universities and organizations around the world are racing to find a vaccine for the COVID-19 virus that has killed more than 650,000 globally.

While many of them are keeping their advancements secret in the competitive environment, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) based at the University of Delaware has launched a high-level series of webinars aimed at getting them to talk to each other to accelerate development and distribution.

“I don’t think we can help any of those big companies get across that first finish line any faster,” NIIMBL Director Kelvin Lee told the Delaware Business Times on July 28 after the first of three planned NIIMBL-hosted webinars with the competing vaccine developers. “But what we can do is work on developing and advancing some of the technologies that can make their manufacturing processes more efficient, and later on we might help in a second or a third generation [vaccine].”

NIIMBL, a public-private partnership tasked with accelerating biopharmaceutical innovation, supporting more efficient manufacturing, and educating a biopharmaceutical manufacturing workforce, is playing a multi-faceted role in the pandemic’s response. Funded by the National Institute of Standards and Technology (NIST) as well as dues from its roughly 150 members, NIIMBL is a member of Manufacturing USA, a diverse network of federally sponsored manufacturing innovation institutes.

NIIMBL Director Kelvin Lee said that he believes multiple COVID-19 vaccines will make it to market within the next year. | PHOTO COURTESY OF EVAN KRAPE/UD

NIIMBL convenes stakeholders to talk about issues, identify problems, and deploy grants to help solve them. It also has its own group of researchers who are working on projects that have not yet been publicly shared, Lee said.

“We have active programs to develop what we like to call ‘test beds’ for new technologies,” he said, noting they explore ideas like new approaches for testing a vaccine or for manufacturing a therapeutic protein. “It’s really trying to get people comfortable with how those next-generation platforms work or don’t work.”

NIIMBL’s webinars are designed to enable vaccine developers to talk about challenges and processes and potentially pick up some best practices and insights. Among the companies represented were Pfizer, Johnson & Johnson, GlaxoSmithKline, Merck, Sanofi and MilliporeSigma.

NIIML Executive Director Barry Buckland noted that while there are dozens of vaccine candidates being studied by the world’s largest pharmaceutical companies, each has chosen different platforms, including live attenuated viruses, recombinant protein, or messenger RNA.

“Everyone’s really gone forward very fast, and, in a way, these are like the first generation,” he said, noting future iterations will likely produce better products. “Then I think there’s more room to collaborate and share ideas about how to make vaccines that are more temperature stable and how to have common methods for testing for foreign viruses that you don’t want, etc.”

Buckland said that the second webinar scheduled for the end of August will bring stakeholders together to see where NIIMBL can apply its expertise to help, while the third will  highlight small to medium-sized companies with novel technologies that could be utilized. He expects that NIIMBL will look to issue a request for proposals in October for projects that may aid in the vaccine development work.

NIIMBL Is connecting vaccine developers and working on its own research to advance processes that will aid future dissemination of a COVID-19 vaccine. | DBT PHOTO BY JACOB OWENS

Buckland expects webinar participants to discuss how to test the potency of a vaccine, how to compare the effectiveness of different vaccine platforms, and how to ensure that a vaccine is sterile, he said.

“This is likely going to be a race with many winners,” Lee said, noting that if multiple vaccine candidates are determined to be effective, they all will be sold to consumers.

The public should think about a future COVID-19 vaccination much like they do an annual flu vaccine, Lee explained. Every year, multiple manufacturers produce different influenza vaccinations that are disseminated through doctors’ offices and pharmacies and consumers rarely ask about the provenance of their shot. If the U.S. Food and Drug Administration has determined it to be effective, it’s sold to consumers.

Once approved, scaling up to the level of vaccine production that will be needed – ostensibly upward of 7.8 billion doses to inoculate everyone on the planet – will be a historic challenge, Buckland said. In the U.S. alone, manufacturers anticipated producing about 160 million doses of the annual flu vaccine last fall, meaning production of the COVID-19 vaccine would need about twice as many doses.

“It’s just a different scale,” Buckland said. “It takes a while to build new facilities, so people are really looking around to see what exists and figure out whether they can use an existing facility to make their product.”

Lee agreed, adding that might be where NIIMBL-backed advancements could help later deliveries of even first-generation vaccines.

“The technological achievements that our community will realize might not impact the first 500 million doses that are manufactured, but it could have an impact on the next 500 million or the second or third billion,” he said. “All of which are going to be needed.”

By Jacob Owens


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