US commits $153m to drive innovation in biopharmaceutical manufacturing
Working through its National Institute of Standards and Technology (NIST), the department has committed $83 million to efforts to prepare the US for future coronavirus outbreaks. The money will support the work of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public-private partnership that lists leading pharma and biotech companies among its members.
The NIIMBL plans to use the money, which NIST will make available over three years, to develop new processes for manufacturing vaccines and therapeutics against coronaviruses.
While the work could help with the management of COVID-19, it is also looking beyond the current crisis to future outbreaks of coronaviruses. SARS-CoV-1, MERS-CoV and SARS-CoV-2 have all crossed over to humans and caused health problems, to varying degrees, over the past 20 years, suggesting that other coronaviruses could impact on societies in the years to come.
Specific NIIMBL goals include the extension of the shelf life of mRNA vaccines, such as those sold by Moderna and Pfizer, and the relaxation of their storage requirements. Enabling vaccines to be stored at higher temperatures for longer could make the logistics of mass-vaccination campaigns easier.
Supporting innovation in domestic biopharma manufacturing
The NIIMBL is also working to “boost capabilities for rapid production of antigens used in testing and screening for new variants and develop novel technologies for detecting counterfeit vaccines, among other things.”
In addition to the COVID-19 funding, which the NIST is providing from the American Rescue Plan, the NIIMBL is set to receive $70m over five years. The funding was triggered by the renewal of the NIST’s federal sponsorship of the public-private partnership and comes with an equal, non-federal cost-matching requirement.
“This award will allow NIIMBL to continue driving innovation in domestic biopharmaceutical manufacturing by developing flexible, agile and cost-effective manufacturing processes that can be scaled up quickly and are less reliant on foreign supply chains,” the commerce department said.
Many NIIMBL coronavirus projects to date have centered on the need to improve testing but work on drugs and vaccines is also underway. The biopharma-focused work includes two projects designed to accelerate development of more flexible biologic manufacturing platforms and rapid release testing.
In one project, the NIIMBL is working on a continuous process to make a monoclonal antibody. The end-to-end manufacturing test bed project is aiming to “accelerate maturation and adoption of protein therapeutic manufacturing technologies.”