Many ingredients that make up the pharmaceuticals Americans rely on are manufactured overseas. When supply chain issues or shortages occur, as witnessed during the COVID pandemic, it can negatively impact millions of Americans and affect national security. The White House issued an Executive Order in 2022 to stimulate U.S. biomanufacturing. Increasing American biomanufacturing, will provide more control over pharmaceutical production, boost the economy, and encourage creation of greener manufacturing methods.
Under a new $7.5 million, two-year project agreement awarded to Capra Biosciences through the BioMaP-Consortium, Capra will demonstrate the ability of its platform to rapidly scale and manufacture biologically derived small molecule active pharmaceutical ingredients (APIs). Capra has a demonstrated history of using its biofilm-forming microbes and proprietary bioreactors to transform low-cost feedstocks into a variety of chemicals, including their first commercial product, retinol.
Under this new project agreement, Capra will leverage its bioreactor platform to demonstrate the manufacture of three active pharmaceutical ingredients, to be selected in cooperation the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
“Biomanufacturing has the potential to manufacture many of the chemicals we use today not only more sustainably, but also where and when we need them. This is an extraordinary opportunity to apply the Capra platform to the important issue of pharmaceutical ingredient shortages,” said Elizabeth Onderko, Capra’s cofounder and CEO. “We look forward to working with the BioMaP-Consortium, their government sponsors, and our partners to increase pharmaceutical manufacturing accessibility in the U.S.”
Successfully creating the pharmaceutical ingredients using a common platform will further illustrate the potential of Capra’s technology to be easily tailored to create a broad spectrum of molecules in a highly scalable manner.
Leveraging AI and Modeling for Quicker Manufacturing
To address the challenge of rapidly onboarding new products and scaling them, Capra brought together a team of companies, including Next Rung Technology. The team’s expertise spans AI modeling, bioprocess scale up, and biomanufacturing. The team will leverage AI design tools to rapidly design and onboard each of the APIs, as well as predict their viability and scalability before production begins.
Using Capra’s modular bioreactors, together with these models, the team will demonstrate production of three target APIs at pilot scale. A strength of biomanufacturing is that the same hardware can be used to rapidly switch between different pharmaceutical ingredients or even other products. With the success of this project, Capra will have a template for rapidly scaling ingredients for pharmaceuticals as well as other applications quickly and cost effectively using their modular platform and locally sourced raw materials.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Office of Industrial Base Manufacturing and Supply Chain (IBMSC), under OT number #75A50123D00003.
Learn more here.