ARPA-H announced on September 1, 2026 that it has selected five teams for its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, committing up to $125 million in research and development funding toward an automated, distributed biomanufacturing network capable of producing individualized, RNA-based genetic medicines on demand, in place of today’s centralized, slow, and costly production models.
GIVE Program Manager John Schiel, Ph.D., said: “Individualized domestic biomanufacturing will give the United States an advantage and ensure that all patients have access to the latest therapeutic capabilities, no matter where they live. The breakthrough manufacturing and quality control technologies needed to enable these therapies to reach patients at scale doesn’t exist yet. This investment will catalyze domestic innovation for distributed manufacturing of RNA-based genetic medicines — and these teams will deliver it in a matter of years, not decades.”
Four Teams Building End-to-End Manufacturing, One Focused on Quality Control
Under the program’s first two technical areas, four teams are building automated, end-to-end platforms capable of producing RNA-based genetic medicines and performing quality control at or near the point of care. Centillion Biosciences Inc. is developing a unified system combining cartridge-based DNA/RNA manufacturing with integrated fill-finish, quality control testing, and digital process management, aiming to deliver scalable manufacturing from personalized to large-scale batches, along with first-of-its-kind measurement technologies and the data-handling capabilities distributed RNA production requires. HDT Bio Corp.’s platform pairs automated DNA synthesis and chip-based RNA production with closed fill-finish and robotics-enabled quality control inside a controlled enclosure. Massachusetts General Hospital is building a single-use, all-fluidics chip system and control unit hardware that enables continuous manufacturing and quality-control testing without a cleanroom or open-air liquid handling — a compact, cost-effective approach the team says can turn around the product in under three days with minimal hardware investment. Waterfall Scientific’s approach is a fully automated benchtop, continuous-flow system with four integrated modules covering DNA production, RNA synthesis, lipid nanoparticle formulation, and fill-finish, plus an autonomous quality control system for lot release.
A fifth team, working under a separate technical area focused solely on quality control, takes a different role in the network. The University of Utah is developing an all-in-one testing platform — using digital microfluidics, advanced optics, and AI — that performs multi-parametric characterization of therapeutics at nanoliter- to microliter-scale in single-use cartridges, enabling full quality control testing and lot release within as little as one day.
ARPA-H says the resulting therapies would target cancer, rare genetic conditions, and chronic diseases, and that it expects the technology to reach patients “in a matter of years, not decades.”
Where the FDA Sees This Fitting In
GIVE will engage the FDA throughout the program to co-develop the regulatory framework needed to bring distributed, individualized genetic medicine manufacturing to scale. Karim Mikhail, B. Pharm., M.S., Acting Director of the FDA’s Center for Biologics Evaluation and Research, tied the program to the agency’s own regulatory approach: “The proposed rule to modernize drug manufacturing reflects FDA’s recognition that the future of drug manufacturing is distributed, and our regulatory framework needs to evolve alongside it. Programs like GIVE that are building the underlying technology for multi-site, individualized biomanufacturing are exactly the kind of innovation this framework is designed to support. We look forward to continuing to work with ARPA-H as this field matures.”
The Stakes: From Months and Six Figures to Days and On-Demand
Personalized treatments like Baby KJ’s revolutionary CRISPR cure currently take months to manufacture, cost hundreds of thousands of dollars, and require years of clinical trials to prove safe and effective. If GIVE succeeds, these therapies could be made locally and on demand, in a fraction of the time and cost. Faster manufacturing could, in turn, help trials move more efficiently. Patients with rare genetic conditions, cancers, and chronic diseases would gain faster access to medicine built around their own biology — wherever they live.
ARPA-H Presence’s in BioHealth Capital and Beyond
ARPA-H — the Advanced Research Projects Agency for Health is committed to solving the most challenging problems in health by developing research programs dedicated to urgency, excellence and honesty. Part of the U.S. Department of Health and Human Services, ARPA-H aims to accelerate breakthroughs that empower every American to realize their full health potential – turning the seemingly impossible to the possible to the actual.
The agency’s administrative core — is based in downtown Washington, D.C., while two consortium-managed hubs carry out its outward-facing work: a Customer Experience Hub in Dallas, TX, and an Investor Catalyst Hub in the greater Boston, MA area. From there, a nationwide network of “spoke” sites at existing research institutions extends the agency’s reach across the country. ARPA-H’s origins trace back to the National Institutes of Health, headquartered in Bethesda, MD.
The ARPA model is a continuous cycle of planning, implementing, and evaluating, and we’re looking for the best ideas and the brightest minds to carry out each process. Find more information about the agency and current job opportunities at https://arpa-h.gov
