Applications Invited for Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing

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From early childhood, we each saw how our parents helped out in our local communities, and we were taught that anything is possible.

Unfortunately, factors outside of anyone’s control make it hard for some people to reach their potential: things like when they were born, who their parents are, where they grew up, whether they are a boy or a girl.

We wake up every day determined to use our resources to create a world where everyone has the opportunity to lead a healthy and productive life. Most importantly, we believe this: All lives have equal value. That’s why we made the decision to donate our wealth from Microsoft to help others.

About the Grant

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.

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.

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.

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

Funding Level

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

This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies and academic institutions. We 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.

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 doses
• 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
• 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

How to Apply

Deadline: Jan 31, 2025, 11:30 am PST

Apply for this Opportunity

For more information please check the Link

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