Low-Cost Mab Manufacturing

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Description

The Bill & Melinda Gates Foundation, in partnership with LifeArc, is seeking proposals for innovative manufacturing platforms capable of producing monoclonal antibodies (mAbs) at a final drug substance cost-of-goods of $10 per gram. The challenge aims to catalyze disruptive bioprocessing approaches that can enable large-scale, affordable mAb production for global health needs, particularly for diseases such as malaria, RSV, and HIV.

There are two application tracks:

• Option A: For proof-of-concept development, including conceptual facility design and lab-scale process data.
• Option B: For organizations with existing proof-of-concept data (Technical Readiness Level 3-5) seeking further development funding.

Proposals should focus on technological innovations that can achieve the cost target at a production scale of one metric ton per year.

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Due Dates

• Option A (Proof-of-Concept): January 31, 2025
• Option B (Further Development): May 31, 2025

Applicants may only submit to one option.

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Funding Amount

• Option A: Up to $750,000 USD per project, with a grant term of up to 18 months.
• Option B: Funding amount and duration are flexible and determined per project, based on the scope and stage of development.

Budgets should be commensurate with the proposed work.

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Eligibility

• Open to:

  • Academic institutions
  • Non-profit organizations
  • For-profit companies
  • International organizations
  • Government agencies

• Only individuals applying through a legally recognized corporate entity are eligible.

• Projects led by women, women-led organizations, or institutions based in low- and middle-income countries are especially encouraged.

• Collaborations are welcome; applicants needing specific expertise can indicate this in their submission.

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Application Process

• Option A: Submit a proposal detailing a conceptual facility design and lab-scale process data demonstrating the ability to meet the $10/gram cost target for malaria antibodies.
• Option B: Submit a proposal with non-confidential data demonstrating Technical Readiness Level 3-5 for malaria, RSV, or HIV antibodies, and outline further development plans.

Applicants should:

• Clearly describe the technological approach and steps to achieve the cost target.
• Include a justification of costs (fully loaded, including reagents, labor, facility, QC/QA, fill-finish, and licensing).
• Demonstrate the technical quality and ability to generate data within 12 months (Option A).
• Outline team capabilities and relevant experience.

Note: Proposals must focus on technological solutions for manufacturing, not on molecule modification, delivery, administration, or incremental improvements.

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Additional Information

• Proposals must target high-volume production (1 metric ton/year).
• Only technological solutions are eligible; non-technological or incremental cost-saving approaches are not considered.
• The challenge is focused on drug substance manufacturing, not drug product or alternative administration routes.
• Each funder (Gates Foundation and LifeArc) will make independent award decisions for Option A; Option B is managed solely by the Gates Foundation.

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External Links

• Challenge Details & Application Portal (Gates Foundation)
• Option B Application Portal
• Technical Readiness Level Guidance (PDF)
• MAM01 Malaria Antibody Reference

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Contact Information