Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing: Option B Grant

Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing: Option B Grant

Status: ACTIVE
Funder: Gates Foundation
Last Updated: February 19, 2025

Summary

The Bill & Melinda Gates Foundation invites innovative proposals to develop low-cost monoclonal antibody (mAb) manufacturing solutions, aiming for a final drug substance cost of $10 per gram. This initiative seeks to harness diverse expertise to enhance production efficiency and reduce costs, ultimately improving access to life-saving treatments in low- and middle-income countries. Collaborators across various scientific disciplines are encouraged to participate in this Grand Challenge, which emphasizes bold ideas and clear pathways to achieving this ambitious goal.

Overview

Bill & Melinda Gates Foundation We are a nonprofit fighting poverty, disease, and inequity around the world. About Grand Challenges Grand Challenges is a family of initiatives fostering innovation to solve key global health and development problems. A Family of Initiatives with One Purpose Grand Challenges initiatives use challenges to focus attention and effort on specific problems, and they can be traced back to the mathematician David Hilbert, who over a century ago defined a set of unsolved problems to spark progress in the field of mathematics. Grand Challenges initiatives launch challenges as open requests for grant proposals, refining the process of sourcing innovation over time. Each challenge is an experiment in focusing innovation on making an impact. Each addresses some of the same problems, but from differing perspectives. Each builds a grant program that fosters collaboration across projects to speed impact. Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing Background Monoclonal antibodies (mAbs) are one of the most powerful tools in modern medicine, offering a highly specific and effective treatment for a range of conditions - from infectious diseases like COVID-19 to chronic illnesses such as cancer and autoimmune disorders. These biologic therapies provide targeted interventions that can save lives and improve the quality of life for millions of patients globally. Yet, the high production costs associated with mAbs limit access to these lifesaving treatments for patients in low- and middle-income settings. With efforts to improve technology and affordability, mAb costs have decreased significantly in the last 30 years and have stagnated at around $50-100 per gram. These high costs are driven by the complexity of the manufacturing process, which involves sophisticated methods, strict regulatory compliance, expensive raw materials, and significant infrastructure investments. Reducing production costs is critical, as many applications of anti-infective antibodies may require doses on the order of hundreds of milligrams (as seen for the antibodies that achieved emergency use authorization and/or approvals for COVID-19). In order to improve mAb affordability in low- and middle-income countries, we will need to reach a final drug substance cost-of-goods of $10 per gram - a goal long championed by our late colleague, Dr. Steve Hadley, former Senior Program Officer at the Gates Foundation. To reach our goal, we will need to draw on innovation and novel approaches from a wide range of scientific and engineering disciplines. While those in the biopharmaceutical field are already deeply engaged in the challenge of reducing mAb manufacturing costs, there is tremendous potential for breakthroughs as we incorporate learnings from adjacent industries, such as dewatering and filtration, blood fractionation, industrial enzymes, and food and beverages. By bringing together diverse expertise and encouraging out-of-the-box thinking, we believe it is possible to achieve this ambitious goal. The Grand Challenges family of initiatives seeks to source and seed innovations and accelerate the development of transformational solutions. The 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 us in this Grand Challenge. Together, we can unlock new pathways to reduce costs, enhance production efficiency, and ultimately expand access to life-saving treatments for all. 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. We 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. The Challenge 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. 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 cultureAlternative to standard downstream purification methodsReduction in material costsPush the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costsRethink existing methods of working such as release testing process and costs, high-quality and affordable raw materials and critical reagents Option B: Operationalization and Economic Viability Option B: Funding Level 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

You can learn more about this opportunity by visiting the funder's website. This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions.  Only individuals who are applying through a legally recognized corporate entity are eligible.We 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 dosesWe 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 costsOutline solutions with specific steps and/or end-to-end solutionsProvide technological solutions to reach the target rather than solutions relying upon multi-use facilities, brown-field facilities and other non-technological solutionsFor the purposes of calculating costs, assume a "green-field" facility producing just a single productClearly outline the capabilities of the team, including a level of demonstrated applicability to a related problem and/or credibility for pharmaceutical applicationsDemonstrate technical quality and the ability to generate data within 12 monthsInclude a justification of costs, which will also be analyzed by an external third-partyWe 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 solutionsArticulate solutions that could enable manufacturing in LMICsFor 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

For this challenge we are not seeking proposals that:Include changes to an existing licensed moleculeRequire 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 solutionsAre focused on solutions for lower-cost delivery and administration of antibodiesThis 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 RFPAre focused on technologies like in-vivo expression of antibodies using nucleic acid and gene deliveryThe Gates Foundation is pursuing alternative paths to these technologies, and they are outside the scope of this RFPInclude cost reductions resulting from price negotiations (e.g., buying materials in bulk)Are focused on stepwise or incremental improvements that result in nominal cost reductionsAre not applicable to global-health target diseases