GIVE
Genetic Medicines and Individualized Manufacturing for Everyone
The Big Question
What if we could manufacture any genetic medicine anywhere in the U.S.?
The Problem
Genetic medicines hold tremendous promise as treatments or preventions for cancer, rare genetic disorders, infections, and other chronic illnesses like autoimmune or cardiovascular diseases. However, they are expensive to manufacture and require centralized equipment, specialized facilities, complex manufacturing optimization, and resource intensive quality control systems. Requirements for ultracold storage and shipping add to the cost and complexity of manufacturing these drug products, especially for personalized and individualized (P/I) genetic medicines. Without innovative manufacturing processes, many products may never advance out of early-stage research and development.
The Solution
The Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program aims to enable a multi-site, multi-product, and multi-scale biomanufacturing network. The goal of the program is to develop reliable, simple to use, distributed manufacturing and quality control platforms for genetic medicines. GIVE’s two focus areas include advanced technologies for automated manufacturing and integrated quality control platforms. By bolstering U.S. biomanufacturing technology, GIVE seeks to first-shore P/I genetic medicine manufacturing and improve patient access to cancer therapies, cell therapies, and gene editing technologies.
Why ARPA-H
Through its health innovation network, ARPA-H can bring together biomanufacturing experts, equipment vendors, researchers, and small and large businesses in the industry to achieve the vision of the GIVE program.
Solicitation
Notice ID: ARPA-H-SOL-25-129
ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply.
Key Dates:
- Solution Summary Due: December 19, 2025
A solution summary is required to submit a full proposal. - Full Proposal Due: February 27, 2026
Encouraged submissions preferred. Additional details will be provided in a solution summary feedback letter.
Reminder: Dates are estimates and subject to change. Please reference the solicitation for the most up-to-date information.
Ready to apply? To submit a Solution Summary or Full Proposal, sign-in to the ARPA-H Solutions Portal.
Frequently Asked Questions
Review responses to common questions about this funding opportunity asked by others in the proposer community.
You can also ask a question.
Proposers' Day
This is an optional event for the proposer community to learn more about this opportunity, ask questions, and make connections. This event is not intended for patients, patient advocates, the media, or general interest audiences.
Hybrid event date and location: to be announced
Please add your name below if you are interested in an email update when Proposers' Day details are published.
Teaming
ARPA-H anticipates that teaming will be necessary to achieve the goals of this program. Prospective performers are encouraged to form teams with varied technical expertise to submit a research proposal.
To facilitate this process, we have created a teaming page where proposers can share their profiles and learn more about other interested parties.
Program Manager
