The Bill & Melinda Gates Foundation and LifeArc have launched a joint Grand Challenges request for proposals for Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing
According to the foundation, monoclonal antibodies are among the most powerful tools in modern medicine. They are highly specific, safe, and effective medicines for a range of conditions, such as treating non-communicable diseases and preventing and treating infectious diseases. But high production costs continue to limit access to mAbs, especially for patients in low- and middle-income settings. While there are indication-specific dosage requirements for mAbs, it is broadly understood that to close the equity gap in mAb global access, we need to reach a target cost of $10 per gram of purified, released mAb.
To that end, this Grand Challenge seeks proposals that offer radical, innovative, and technically feasible pathways to achieving the $10/gram target. 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. Applicants can apply with solutions that meet 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 (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. Proposals of up to $750,000 for each project, with a grant term of up to 18 months will be awarded.
Option B: Operationalization and Economic Viability: Independent of the Proof-of-Concept (Option A), the 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. 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.
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. 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 are particularly encouraged. Only individuals who are applying through a legally recognized corporate entity are eligible.