Ginkgo Bioworks announced a new contract with the Advanced Research Projects Agency for Health (ARPA-H), alongside partners Tritica Biosciences, US Pharmacopeia (USP), On Demand Pharmaceuticals, and Isolere Bio by Donaldson. 

The two-year program, Wheat-based High-efficiency Enzyme and API Technology (WHEAT), 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.

By utilizing wheat germ and developing methods to produce medicines exactly where and when they are needed, the partnership seeks to create a new paradigm for domestic manufacturing of critical medicines, stabilizing and reshoring supply chains for essential pharmaceuticals. This strategy shifts API production to a decentralized system using Cell-Free Protein Synthesis (CFPS).

Per the contract, Ginkgo will combine its Enzyme Services and expertise in cell-free systems with its partners in upstream extract preparation, API downstream processing, quality metrics, and modular, on-demand API manufacturing methods, to develop affordable cell-free biological processes to produce essential medicines. 

WHEAT aims to demonstrate scalable and decentralized processes for CFPS-based production of complex APIs, focusing on targets where biocatalysis can wholly or partially complete syntheses, and where current supply chains are constrained to natural products or overseas providers. 

Additionally, WHEAT’s innovations in protein post-translational modifications (PTMs) aim to establish a foundation suitable to produce biologics such as growth factors and insulin.

The project brings together non-profit and corporate partners based in Massachusetts, Kansas, Maryland, and Minnesota. Ginkgo Bioworks will use its machine learning, computational tools, and predictive approaches to engineer enzymes and optimize cell-free expression systems.

This program represents one of the first initiatives within ARPA-H’s Scalable Solutions Office, aimed at transforming the health of all Americans by improving the speed, scale, and access to medical treatments and enhancing health security in the U.S.