Capra Biosciences, Inc. (Manassas, Virginia), a biomanufacturing company leveraging modular, continuous bioreactor technology to enable flexible, cost-competitive domestic production of pharmaceutical ingredients, today announced continued progress under its project agreement with the Administration for Strategic Preparedness and Response (ASPR; Washington, D.C.), part of the U.S. Department of Health and Human Services (HHS; Washington, D.C.).
The additional investment brings Capra’s total ASPR funding to approximately $17 million and supports the company’s ongoing efforts to onshore the production of critical active pharmaceutical ingredients (APIs) currently sourced almost exclusively overseas.
“Biotechnology offers tremendous power over traditional chemistry for making APIs because it is not limited by supply chains for key starting materials. With our initial ASPR funding, we successfully demonstrated that our modular reactors can produce high-quality APIs. This continued support enables us to take the next step toward cGMP production and regulatory filings that put these molecules on a path to market.” — Andrew Magyar, Ph.D., Co-Founder & CTO, Capra Biosciences (Manassas, Virginia)
Under its initial $7.5 million ASPR award, announced in July 2024, Capra executed its CoMPASS (Continuous BioManufacturing Process Analysis for Scaling API Synthesis) project, building an AI-enabled pipeline for rapid development and scaling of biologically derived pharmaceutical ingredients. Working in collaboration with X Development LLC‘s (Mountain View, California) A-Life team, Capra combined advanced AI predictions for gene and pathway expression with its proprietary synthetic biology capabilities to accelerate upstream strain engineering.
As a result, Capra successfully validated production of two API targets — aspirin and acetaminophen — in its modular bioreactors in less than two years, a radically accelerated timeline for the industry. The project validated Capra’s ability to deliver multiple APIs with quick turnaround and led to additional investment for additional APIs.
Capra will now apply the rapid development and scale-up capabilities developed with X Development LLC (Mountain View, California) and Next Rung Technology (Somerville, Massachusetts) to additional critical pharmaceutical ingredients, bringing the company’s total number of API targets for domestic production to seven.
Capra plans to work with the United States Pharmacopeia (USP; Rockville, Maryland) to advance five of the seven APIs to population-scale, commercially mature manufacturing (Technology Readiness Level 10). USP will help to accelerate biomanufacturing readiness of these essential APIs through analytical development and testing, working with its Pharmatech subsidiary to offer control strategy development, chemistry, manufacturing, and controls (CMC), and regulatory support. USP is an independent, non-profit organization that collaborates with scientific experts and global stakeholders to develop science-based standards and solutions that help simplify complex manufacturing supply chains, enhance supply reliability and quality, and support the adoption of innovation.