NEWARK – The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) was recently awarded $153 million in new funding from its federal partners, including $83 million specifically to work on coronavirus-related projects.
“Obviously, there’s an element of COVID-19, but also a big part of it is how we make sure we never have this happen again,” explained Kelvin Lee, the director of the institute headquartered at the University of Delaware’s STAR Campus.
Funded by the National Institute of Standards and Technology (NIST) as well as dues from its roughly 180 members, NIIMBL is a member of Manufacturing USA, a diverse network of federally sponsored manufacturing innovation institutes. The 4-year-old, public-private partnership tasked with accelerating biopharmaceutical innovation, supporting more efficient manufacturing, and educating a biopharmaceutical manufacturing workforce, already played a multi-faceted role in the pandemic’s response.
It received about $9 million from the federal CARES Act approved last year to help facilitate the development and manufacturing of the first COVID-19 vaccines. The organization held a series of video-conferences for high-ranking officials at many of the biggest pharmaceutical companies to talk through logistical issues in the work.
“A lot of the challenges that our community within NIIMBL is working on is how to accelerate the manufacturing once the medicine is identified. How can you accelerate this scale up? I mean we’re talking not about 5,000 doses, we’re talking about a billion doses,” Lee said.
The new $83 million comes by way of the Biden administration’s American Rescue Plan and looks to help alleviate some of those issues by developing a national supply chain database for biopharmaceutical manufacturers.
“One of the things that the COVID 19 pandemic exposed – really across all sectors – is the fragility of supply chains,” Lee added, noting that the country saw inventory issues on everything from ventilators to personal protective equipment (PPE) to toilet paper. “One of the things that my colleagues from some other sister manufacturing institutes talk about in other sectors is how a lot of the supply chain is still done with telephone calls and fax machines.”
With contract manufacturers often actually procuring glass vials, labels, cardboard boxes and more to produce vaccines for public use, there needs to be a more streamlined way to signal from raw material suppliers to end-product producers that an emergency is emerging, Lee said.
With NIIMBL leading education on the industry’s latest technologies and best practices, it will also look to help build up the nation’s biopharmaceutical manufacturing workforce, which has traditionally operated below capacity. The lack of skilled laborers to work in plants making the needed medicines can lead to errors like those seen at Emergent BioSolution’s factory in Baltimore, where 75 million doses had to be discarded after production errors, including mixing up ingredients of AstraZeneca’s and Johnson & Johnson’s vaccines.
“These are jobs on the manufacturing floor or doing quality assurance or in an analytical lab, where you need people who basically just need to be trained up on the standard operating procedures, operate these relatively expensive pieces of equipment, and get the products moving through that process. And I think one of the problems is that when we scaled up for the pandemic, we scaled up manufacturing, but we didn’t have all the people,” Lee said.
He also noted that at the outset of the pandemic, Trump administration officials recognized that the U.S. lacked the needed manufacturing expertise to set up additional vaccine plants, and expedited visas for foreign nationals with the skills to come here and do so.
To assist in the growth of such workers here, NIIMBL is looking to add to existing training programs around the country, including likely in Delaware, to open up more opportunities for jobs.
The ARP funds will also support the creation of a Center for Vaccine, Analytics and Assays that will streamline access to, and support of, the latest technologies related to vaccine development and manufacturing to aid in quality assurance of finished products.
Finally, some of the ARP funding will also go toward developing more stable future vaccines, especially those using messenger RNA (mRNA). The Pfizer and Moderna vaccines that depend on mRNA to trigger the needed autoimmune response to fight the virus need low or ultra-low temperatures to stay effective, he noted.
The requirement of refrigerators or ultra-cold freezers for the vaccines transportation and storage means that the incredibly effective medicines are difficult to deliver to areas like Southeast Asia, Africa, and Latin America that often don’t have access to those resources, or even electricity. The portability of vaccines was already a challenge that NIIMBL was working on with support from the Bill & Melinda Gates Foundation, and the new federal funds will assist that research, Lee said.
