Revolutionizing Biomanufacturing for Personalized Genetic Medicines
The Advanced Research Projects Agency for Health (ARPA-H), through its Scalable Solutions Office (SSO), has released an Innovative Solutions Opening (ISO) titled Genetic Medicines and Individualized Manufacturing for Everyone (GIVE). This bold initiative seeks to accelerate U.S. leadership in biomanufacturing by enabling distributed, on-demand, and individualized production of genetic medicines, particularly RNA-based therapies. By moving away from centralized facilities, GIVE envisions a future where lifesaving genetic medicines can be produced rapidly, locally, and affordably for patients nationwide.
Solicitation Overview
At its core, GIVE is designed to address the longstanding bottlenecks of centralized biomanufacturing—high costs, extended timelines, cold-chain logistics, and limited patient access. The program will catalyze innovation in automated manufacturing systems, integrated quality control, and distributed production networks. ARPA-H emphasizes that this effort is not about incremental improvements, but rather about creating a fundamentally different biomanufacturing paradigm.
The GIVE program pursues three overarching goals:
- Automated Manufacturing: Develop a fully cell-free RNA manufacturing and formulation system that is modular, automated, and GMP-ready.
- Integrated Quality Control: Build highly automated, compact, and digitally integrated QC systems for rapid lot release.
- Distributed Biomanufacturing Networks: Demonstrate a first-of-its-kind multi-site system capable of producing GMP-quality genetic medicines outside of traditional GMP facilities, such as hospitals.
The solicitation is structured across two Technical Areas (TAs):
- TA1: Automated RNA Manufacturing
- TA2: Integrated Quality Control
Offerors may apply to one or both areas, and ARPA-H strongly encourages teaming among biopharmaceutical firms, contract development and manufacturing organizations (CDMOs), academics, equipment vendors, and software providers.
Program Structure and Phases
The GIVE program will run over 54 months and is divided into three phases:
- Phase 1 (6 months); Engineering and software design.
- Phase 2 (24 months): Non-GMP demonstration runs of at least three RNA products.
- Phase 3 (24 months): GMP demonstration runs, commercialization planning, and regulatory readiness.
Independent Verification and Validation (IV&V) will be conducted by ARPA-H to ensure the developed technologies meet real-world standards, including cybersecurity and biosecurity requirements.
Key Dates
Proposers should take note of the following deadlines:
- Proposer’s Day and Teaming Webinars: On November 13, 2025
- Solution Summaries Due: December 19, 2025, at 5:00 PM ET
- Question Submission: February 13, 2026, 5:00 PM ET
- Full Proposals Due: February 27, 2026, at 5:00 PM ET
Funding Information
ARPA-H anticipates making multiple awards under Other Transaction (OT) Agreements. Resource and cost sharing are not required but are strongly encouraged, particularly for Phases 2 and 3. Awards will be competitive, and not all awardees are guaranteed to progress through each phase. The program is designed to down-select performers based on milestone performance and available funding.
Advancing Human Health
By enabling localized, flexible, and rapid production of genetic medicines, GIVE represents a transformative step in delivering therapies for cancer, rare diseases, and chronic conditions. Instead of waiting years and paying prohibitive costs, patients could gain access to individualized therapies within days of diagnosis. This shift will redefine not only U.S. biomanufacturing but also global healthcare equity.
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