Impact Funding Resources
The Gates Foundation and LifeArc are soliciting proposals to develop proof-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram (Option A). The goal is to catalyze and accelerate multiple, diverse, innovative bioprocessing approaches that hold the promise of low cost-of-goods mAbs.
Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).
Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options.
Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).
Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options.
Start Date18 Nov 2024 End Date31 May 2025 Funding AmountPer-project basis Funding Resource TypeGrant
Funding ProviderBill & Melinda Gates Foundation
Grant
Bill & Melinda Gates Foundation
Additionally, the Gates Foundation is interested in hearing from organizations that have already completed proof-of-concept work that could result in cost-of-goods of $10 per gram and may be interested in additional support (Option B).
Applicants can apply with solutions meeting the criteria for either Option A or Option B but should not submit entries to both options.
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. If you have existing data meeting Technical Readiness Level 3-5 (POC Defined, Lab Scale Demonstrated, or Pilot Scale Demonstrated) please share a solution with additional information listed below, as well as any non-confidential data demonstrating Technical Readiness Level 3-5 for production of a monoclonal antibody at a final drug substance cost-of-goods of $10 per gram. The proposal review committee will evaluate this information and reach out to you if there is interest in exploring further.
The challenge is 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
o We 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
o 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
• We 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 we 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
