America’s New Pharma Frontier: Making Medicines Without Cells

USP and Ginkgo fast track cell free drug production to cut imports and future proof U.S. medicine supply.

24 Apr 2025

A new American experiment in biotechnology is trying to make vital drugs without growing a single living cell. The United States Pharmacopeia (USP), a non-profit that sets medicine standards, and Ginkgo Bioworks, a synthetic-biology firm, are developing a “cell-free” system to manufacture active pharmaceutical ingredients (APIs). Funded by ARPA-H, the WHEAT project uses wheat-germ extract to produce medicines in hours, without the fermentation tanks or microbial cultures that normally take days to yield results.

The ambition is strategic as much as scientific. Around two-thirds of America’s APIs are imported. The pandemic exposed how fragile that dependence could be, as lockdowns abroad snarled supply chains and left hospitals short. WHEAT aims to make production local, flexible and quick, potentially in small facilities close to the patients who need the drugs.

Instead of nurturing cells, the system harnesses purified cellular machinery, which can churn out compounds more rapidly. Ginkgo brings its automated biological-design tools; USP ensures the chemistry meets rigorous standards. “Advanced manufacturing technologies and biomanufacturing are critical to bolstering supply chain resilience,” says Ronald Piervincenzi, USP’s boss. Jesse Dill of Ginkgo calls the work a chance to merge “innovations in farm and pharma”.

Technical and bureaucratic hurdles remain. Scaling up cell-free systems for complex drugs will require more research. Regulators, used to overseeing cell-based production, will need to adapt rules for a technology that bypasses it entirely. If those problems are solved, the model could produce not just APIs but vaccines or enzymes, on demand.

That could allow America to replace some of its vast, centralised drug factories with nimble production hubs, an insurance policy against the next crisis. The country would be less at the mercy of distant suppliers, and more able to make medicines as needed, rather than as shipped.