Decentralizing medicines manufacturing in the U.S.

Most active pharmaceutical ingredients (APIs) in the U.S. are made overseas, which can create supply chain vulnerabilities, security concerns, and prolonged shortages. A new manufacturing approach powered by wheat germ could help expand API production in the U.S., produce manufacturing efficiencies, and drive innovative technologies that enable distributed pharmaceutical manufacturing.

What’s at stake 

Developing a better, faster, and cheaper manufacturing process using wheat germ cell-free expression systems employed in API manufacturing processes could help U.S. manufacturers make a range of essential medicines that stabilize and reshore API production in the U.S., reducing reliance on foreign countries for critical ingredients and decreasing potential supply chain disruptions.

 

A new manufacturing approach powered by wheat germ could help U.S. producers make biologics and small-molecule drugs more quickly, efficiently, and affordably.

ARPA-H WHEAT project
ARPA-H WHEAT project

Project at-a-glance 

  • Timeline: 2025 – 2027
  • Funder: Advanced Research Projects Agency for Health (ARPA-H)
  • Country: U.S.
  • Technical areas: Regional manufacturing

Project goal

The ARPA-H WHEAT project, led by Ginkgo Bioworks, in partnership with USP and other collaborators, including Tritica Biosciences, On Demand Pharmaceuticals, and Isolere Bio by Donaldson will: 

  • Work to establish new manufacturing processes that support the decentralized production of essential medicines, including biologic and small molecule APIs, utilizing wheat germ cell-free expression systems.

Key milestones 

  • Identify the best, most efficient wheat germ cell-free expression systems that demonstrate new pathways for the synthesis of select small molecule and biologic APIs.
  • Optimize processes and demonstrate cost efficient, robust, and high quality cell-free protein synthesis (CFPS) for APIs.
  • Ensure quality solutions, including process control strategies and quality testing methods for CFPS-based processes that demonstrate reproducible performance and support future scale-up, technology transfer, and commercialization. 

Related resources 

Advanced manufacturing technologies 

Advanced manufacturing technologies  

Reducing barriers to innovation to make more quality medicines in more places.  

Explore our technical expertise

Federal government solutions

Federal government solutions  

Delivering standards and solutions for end-to-end medicines supply chain security in partnership with U.S. government, industry, and academic institutions.  

Learn more

newsletter sign-up

Get the latest updates on global health projects.

Sign up for our newsletter