April 10, 2025
Rockville, MD – The United States Pharmacopeia, as part of a consortium led by Ginkgo Bioworks, was selected by Advanced Research Projects Agency for Health (ARPA-H) for the two-year Wheat-based High-efficiency Enzyme and API Technology (WHEAT) project. The WHEAT project aims to establish a new manufacturing process for the distributed production of biologic and small molecule active pharmaceutical ingredients (APIs) using wheat germ cell-free expression systems.
As the nation faces prolonged shortages of critical medicines, USP plans to work with the Ginkgo Bioworks-led consortium to foster supply chain security through the development of new and efficient biomanufacturing processes to strengthen pharmaceutical supply chains. USP will help to accelerate biomanufacturing innovations through quality system and process control strategy development, particularly for advanced manufacturing technologies, to help assure the quality of the APIs.
“Advanced manufacturing technologies and biomanufacturing are critical to bolstering supply chain resilience,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “USP is proud to contribute our scientific expertise to develop standardized solutions, process control strategies, and quality testing methods that pave the way for broader adoption, future regulatory approval and commercialization.”
Read the full statement from Ginkgo Bioworks.
Media contact: mediarelations@usp.org
About US Pharmacopeia
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide.