ARPA-H commits up to $125 million to on-demand personalized RNA medicines

ARPA-H is awarding up to $125 million to five teams through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program.

The initiative aims to create automated, distributed systems that can produce personalized RNA-based genetic medicines—including treatments for cancer, rare diseases, and gene-editing applications—at or near the point of care.

Funded teams include Centillion Biosciences, HDT Bio, Massachusetts General Hospital, the University of Utah, and Waterfall Scientific.

The platforms are designed to integrate DNA/RNA synthesis, RNA production, lipid-nanoparticle formulation, fill-finish, and rapid quality-control testing. One University of Utah system aims to enable lot release in as little as one day.

Waterfall Scientific received up to $54.5 million to lead a consortium developing a continuous-flow, cell-free mRNA manufacturing and characterization platform.

ARPA-H says personalized therapies currently can take months to manufacture, cost hundreds of thousands of dollars, and face difficult cold-chain and quality-control requirements. GIVE is intended to reduce time, cost, and logistical barriers.

The agency also plans to work with the FDA on a regulatory framework for distributed, individualized genetic-medicine manufacturing.