GENETIC MEDICINES AND INDIVIDUALIZED MANUFACTURING FOR EVERYONE (GIVE)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Advanced Research Projects Agency for Health (ARPA-H), under the National Institutes of Health, has issued a Solicitation (ARPA-H-SOL-25-129) for the Genetic Medicines And Individualized Manufacturing For Everyone (GIVE) Program. This program seeks to accelerate biomanufacturing equipment and process innovation, digital transformation, and next-generation therapies, specifically focused on RNA-containing modalities. The goal is to achieve localized, accessible, and individualized biomanufacturing through human-machine collaboration and elimination of scale-up costs.
Scope of Work
The GIVE Program aims to:
- Accelerate innovation in the manufacture, testing, and release of RNA-containing modalities.
- Harness human-machine collaboration.
- Eliminate scale-up costs.
- Drive toward localized, accessible, and individualized biomanufacturing.
Amendment 01 (ARPA-H-SN-26-140) clarifies specific requirements:
- For ex vivo RNA-based cell therapy, the RNA product considered is explicitly the RNA-containing modality.
- Alternative approach solutions must perform RNA product demonstrations and address regulatory assessment, business model description, and technoeconomic feasibility.
- Offerors must submit Quality Target Product Profiles (QTPPs) for three RNA products from at least three different classes (e.g., mRNA, saRNA, transRNA, circRNA) and each from a different category.
- Infectious disease vaccines remain out of scope.
Contract & Timeline
- Contract Type: Solicitation (Innovative Solutions Opening - ISO)
- Product Service Code: AN13 (Health R&D Services; Health Care Services; Experimental Development)
- Set-Aside: None specified
- Place of Performance: Washington, DC, United States
- Published Date: October 10, 2025
- Proposer's Day: November 13, 2025 (details in Special Notice ARPA-H-SN-26-140)
- Solution Summaries Due: December 19, 2025, 5:00 PM ET
- Question Submission Due: February 13, 2026
- Full Proposals Due: February 27, 2026
Submission & Contact
- Solution Summaries Submission Site:
https://solutions.arpa-h.gov/Submit-Solution/ - A solution summary must be submitted to submit a proposal.
- For program information, visit:
https://arpa-h.gov/explore-funding/programs/give - Contact information is detailed in the description section of the ISO; the provided email
do_NOT_use_THIS_email_ADDRESS@arpa-h.govis a placeholder.
Amendment Details
Amendment 01 (posted October 03, 2025) modifies key dates and clarifies sections 2.2.1, 2.3, and Attachment B2. Bidders should review the attached GIVE_ISO_Amend_01_20251003 for full details.