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. The Option A (Proof-of-Concept) part of this Grand Challenge is a collaboration between the Gates Foundation and LifeArc, however each funder will make independent funding decisions. Following the RFP process, organizations with successful applications will be invited to submit their proposal on Gates Foundation or LifeArc standard proposal templates in alignment with each potential funder's due diligence process as applicable.
Start Date18 Nov 2024 End Date31 Jan 2025 Funding AmountUSD 750k Funding Resource TypeGrant
Funding ProviderBill & Melinda Gates Foundation,LifeArc
Grant
Bill & Melinda Gates Foundation,LifeArc
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.
The Option A (Proof-of-Concept) part of this Grand Challenge is a collaboration between the Gates Foundation and LifeArc, however each funder will make independent funding decisions. Following the RFP process, organizations with successful applications will be invited to submit their proposal on Gates Foundation or LifeArc standard proposal templates in alignment with each potential funder's due diligence process as applicable.
The primary outputs of this challenge will be (1) development of a conceptual facility design, and (2) 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). A full physical demonstration that the manufacturing platform meets specific manufacturing cost targets is not required at this stage. If the success criteria from this process are met and if additional funding is available, Option A applicants may be eligible for further support in a follow-on phase of work.
A full physical demonstration that the manufacturing platform meets specific manufacturing cost targets is not required at this stage. If the success criteria from this process are met and if additional funding is available,
Option A applicants may be eligible for further support in a follow-on phase of work.
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
