CFAs: Innovations for Exceptionally Low-Cost Monoclonal Antibody Manufacturing Program

Deadline: 31 May 2025

The Bill & Melinda Gates Foundation, in collaboration with LifeArc, a self-funded medical research charity in the UK, is calling on innovators, scientists, engineers, and entrepreneurs- whether they are seasoned experts in biologics or pioneers in related fields- to join them in this Grand Challenge.

This Grand Challenge is calling for proposals that are bold in their vision and approach, offering clear pathways to achieving the $10 per gram target. This is not just a technical challenge; it is an opportunity to make a lasting impact on the lives of millions of people worldwide. They invite you to bring your expertise, creativity, and passion to this effort and help shape a future where the best medical treatments are available to everyone, everywhere.

Objectives

Objectives of the challenge (both Option A and Option B)
- Advance innovative and bold ideas that enhance production efficiency and improve overall process economics for mAb production, resulting in a final drug substance cost-of-goods of $10 per gram. This includes, but is not limited to:
  - Alternative hosts to mammalian cell culture
  - Alternative to standard downstream purification methods
  - Reduction in material costs
- Push the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costs
- Rethink existing methods of working such as release testing process and costs, high-quality and affordable raw materials and critical reagents

Categories

Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options:
- Option A: Proof-of-Concept:
  - The primary outputs of this challenge will be, development of a conceptual facility design, and generation of bench or lab-scale process data with sufficient analytical data to demonstrate the ability to produce an antibody at a final drug substance cost-of-goods of $10 per gram that could meet requirements for human applications and would support a rigorous cost-of-goods assessment by a third-party organization (chosen by the Foundation).
- Option B: Operationalization and Economic Viability
  - Independent of the Proof-of-Concept (Option A), the Gates Foundation recognizes that some organizations may already have proof-of-concept data that could support a final drug substance cost-of-goods of $10 per gram and would like to partner for further development funding.

Funding Information

Option A: The Gates Foundation and LifeArc will consider several proposals for awards of up to $750,000 USD for each project, with a grant term of up to 18 months. Each organization will make coordinated but independent award decisions. Application budgets should be commensurate with the scope of work proposed.
Option B: Potential funding and grant terms will be evaluated on a per-project basis. The funding and timeline are intentionally open given that the work is exploratory at this time. Application budgets should be commensurate with the scope of work being proposed.

Eligibility Criteria

For both option A and B:
- This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions. They particularly encourage applications involving projects led by women/in collaboration with women-led organizations, and/or applications from/in collaboration with institutions based in low- and middle-income countries. Only individuals who are applying through a legally recognized corporate entity are eligible.
They are looking for proposals that:
- Would work with the MAM01 malaria antibodies (Option A applicants) or malaria, RSV, or HIV antibodies (Option B applicants) requiring high doses
  - They are focused on applications capable of producing antibodies at volumes of a metric ton per year and are modeled assuming tonnage demand (1000 kg per year)
- Include fully loaded costs inclusive of reagents, consumables, labor, facility-related costs, QC/QA (quality control, quality assurance) costs, fill-finish, and licensing costs
- Outline solutions with specific steps and/or end-to-end solutions
- Provide technological solutions to reach the target rather than solutions relying upon multi-use facilities, brown-field facilities and other non-technological solutions
- For the purposes of calculating costs, assume a “green-field” facility producing just a single product
- Clearly outline the capabilities of the team, including a level of demonstrated applicability to a related problem and/or credibility for pharmaceutical applications
- Demonstrate technical quality and the ability to generate data within 12 months
- Include a justification of costs, which will also be analyzed by an external third-party
- They encourage applications that may include a number of collaborators who each bring specific expertise. If applicants need partners with specific expertise, please identify so within your proposal submission and They will consider areas to encourage collaboration amongst different applicants to enable end-to-end solutions
- Articulate solutions that could enable manufacturing in LMICs
- For applicants interested in Option B: Please share any non-confidential data sharing that technical readiness level 3-5 has been met for low-cost production of HIV, RSV, or malaria antibodies

Ineligibility Criteria

For this challenge they are not seeking proposals that:
- Include changes to an existing licensed molecule
- Require changes to the coding of sequence of standard human- or humanized-IgG1s.
  - Since the foundation is separately funding the development of protein molecules with improved affinity and potency, this particular RFP is focused on manufacturing solutions
- Are focused on solutions for lower-cost delivery and administration of antibodies
  - This RFP is focused on drug substance only so applications on DP (drug product), filled container and alternative administration routes (oral, nasal, ID, etc.) are outside the scope of this RFP
- Are focused on technologies like in-vivo expression of antibodies using nucleic acid and gene delivery
  - The Gates Foundation is pursuing alternative paths to these technologies, and they are outside the scope of this RFP
- Include cost reductions resulting from price negotiations (e.g., buying materials in bulk)
- Are focused on stepwise or incremental improvements that result in nominal cost reductions
- Are not applicable to global-health target diseases