ARPA-H backs USD 125m push for distributed RNA manufacturing

The Advanced Research Projects Agency for Health (ARPA-H) has selected five teams to receive contract awards totaling up to USD 125 million under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, targeting a core bottleneck in RNA-based medicine: the centralized, slow, and costly production infrastructure that limits patient access.

Current manufacturing of individualized genetic medicines depends on specialized centralized facilities, extended production timelines, and cold-chain logistics — constraints that restrict access to patients near major biomanufacturing centers. GIVE is designed to replace that model with automated, distributed platforms capable of producing RNA-based therapeutics at or near the point of care, with integrated real-time quality control. ARPA-H said it will also engage the US FDA throughout the program to co-develop the regulatory framework required for distributed, multi-site individualized manufacturing.

Four teams were selected under the combined TA1 and TA2 technical areas, tasked with building automated distributed manufacturing platforms with integrated quality control.

Centillion Biosciences will develop an end-to-end system using cartridge-based technologies for DNA and RNA manufacturing, integrated fill-and-finish, quality control testing, and digital process management — designed to scale from personalized to larger production runs.

HDT Bio Corp will build a platform integrating automated DNA synthesis, chip-based RNA production, closed fill-and-finish, embedded process analytical technologies, and robotics-enabled quality control inside a controlled enclosure with electronic batch records.

Massachusetts General Hospital will develop a single-use, all-fluidics chip system capable of continuous manufacturing and quality control testing within a closed fluidic path, eliminating open-air liquid handling and cleanroom requirements. The team said the approach targets a production cycle of under three days.

Waterfall Scientific will develop a fully automated, benchtop, continuous-flow system organized around four integrated modular units: cell-free enzymatic DNA production, continuous-flow RNA synthesis, lipid nanoparticle (LNP) formulation, and fill-and-finish — drawing on a consortium of partner organizations. Its quality control system will combine in-line, at-line, and off-line drug product characterization using proprietary software and robotics.

Under the TA2 quality control track, the University of Utah will develop an all-in-one genetic medicine testing platform using digital microfluidics, advanced optics, and artificial intelligence to perform multi-parametric characterization of therapeutics at nanoliter-to-microliter scale in compact, single-use cartridges, the agency said. The team said the platform is designed to complete full quality control testing and lot release within one day.

Regulatory engagement

ARPA-H said GIVE will work with the FDA's Center for Biologics Evaluation and Research (CBER) throughout development. Karim Mikhail, Acting Director of CBER, said the FDA's proposals to modernize drug manufacturing reflects the agency's recognition that distributed manufacturing will require an evolved regulatory framework, and described GIVE as aligned with that direction. FDA involvement is intended to address the regulatory framework needed for distributed, multi-site manufacturing alongside development of the technology.

RNA-based medicines — including mRNA vaccines and emerging personalized cancer therapies — have demonstrated clinical utility but remain constrained by infrastructure that was not designed for individualized, decentralized production. GIVE reflects a broader push to modernize that infrastructure. In July, the FDA proposed a rule that would create a streamlined registration pathway for distributed drug-production sites operating under a hub-and-spoke model.

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