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

About the Organization

From early childhood, we every noticed how our mother and father helped out in our native communities, and we have been taught that something is feasible.

Unfortunately, elements exterior of anybody’s management make it arduous for some folks to achieve their potential: issues like once they have been born, who their mother and father are, the place they grew up, whether or not they’re a boy or a lady.

We get up day by day decided to make use of our assets to create a world the place everybody has the chance to guide a wholesome and productive life. Most importantly, we consider this: All lives have equal worth. That’s why we made the choice to donate our wealth from Microsoft to assist 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 closing drug substance cost-of-goods of $10 per gram (Option A). The objective is to catalyze and speed up a number of, numerous, modern bioprocessing approaches that maintain the promise of low cost-of-goods mAbs.

Additionally, the Gates Foundation is concerned with listening to from organizations which have already accomplished proof-of-concept work that would lead to cost-of-goods of $10 per gram and could also be concerned with further help (Option B).

Applicants can apply with options assembly the standards for both Option A or Option B however shouldn’t submit entries to each choices.

Option A: Proof-of-Concept

The main outputs of this problem will likely be (1) growth of a conceptual facility design, and (2) technology of bench or lab-scale course of knowledge with adequate analytical knowledge to exhibit the power to supply an antibody at a closing drug substance cost-of-goods of $10 per gram that would meet necessities for human functions and would help a rigorous cost-of-goods evaluation by a third-party group (chosen by the Foundation). A full bodily demonstration that the manufacturing platform meets particular manufacturing price targets isn’t required at this stage. If the success standards from this course of are met and if further funding is offered, Option A candidates could also be eligible for additional help in a follow-on part of labor.

Option B: Operationalization and Economic Viability

Independent of the Proof-of-Concept (Option A), the Gates Foundation acknowledges that some organizations could have already got proof-of-concept knowledge that would help a closing drug substance cost-of-goods of $10 per gram and want to associate for additional growth funding. If you’ve got present knowledge assembly Technical Readiness Level 3-5 (POC Defined, Lab Scale Demonstrated, or Pilot Scale Demonstrated) please share an answer with further data listed beneath, in addition to any non-confidential knowledge demonstrating Technical Readiness Level 3-5 for manufacturing of a monoclonal antibody at a closing drug substance cost-of-goods of $10 per gram. The proposal evaluation committee will consider this data and attain out to you if there may be curiosity in exploring additional.

Objectives of the problem (each Option A and Option B)

• Advance modern and daring concepts that improve manufacturing effectivity and enhance total course of economics for mAb manufacturing, leading to a closing drug substance cost-of-goods of $10 per gram. This consists of, however isn’t restricted to:
• Alternative hosts to mammalian cell tradition
• Alternative to plain downstream purification strategies
• Reduction in materials prices
• Push the boundaries of present know-how by harnessing disruptive improvements, presumably from parallel industries, and establish course of enhancements to cut back manufacturing prices
• Rethink present strategies of working corresponding to launch testing course of and prices, high-quality and inexpensive uncooked supplies and significant reagents

Funding Level

Option A: The Gates Foundation and LifeArc will contemplate a number of proposals for awards of as much as $750,000 USD for every venture, with a grant time period of as much as 18 months. Each group will make coordinated however unbiased award choices. Application budgets needs to be commensurate with the scope of labor proposed.

Option B: Potential funding and grant phrases will likely be evaluated on a per-project foundation. The funding and timeline are deliberately open provided that the work is exploratory presently. Application budgets needs to be commensurate with the scope of labor being proposed.

Eligibility

This initiative is open to nonprofit organizations, for-profit firms, worldwide organizations, authorities businesses and educational establishments. We significantly encourage functions involving tasks led by ladies / in collaboration with women-led organizations, and/or functions from / in collaboration with establishments primarily based in low- and middle-income international locations. Only people who’re making use of by way of a legally acknowledged company entity are eligible.

We are trying for proposals that:

• Would work with the MAM01 malaria antibodies (Option A candidates) or malaria, RSV, or HIV antibodies (Option B candidates) requiring excessive doses
• We are centered on functions able to producing antibodies at volumes of a metric ton per yr and are modeled assuming tonnage demand (1000 kg per yr)
• Include absolutely loaded prices inclusive of reagents, consumables, labor, facility-related prices, QC/QA (high quality management, high quality assurance) prices, fill-finish, and licensing prices
• Outline options with particular steps and/or end-to-end options
• Provide technological options to achieve the goal reasonably than options relying upon multi-use amenities, brown-field amenities and different non-technological options
• For the needs of calculating prices, assume a “green-field” facility producing only a single product
• Clearly define the capabilities of the workforce, together with a stage of demonstrated applicability to a associated drawback and/or credibility for pharmaceutical functions
• Demonstrate technical high quality and the power to generate knowledge inside 12 months
• Include a justification of prices, which can even be analyzed by an exterior third-party
• We encourage functions that will embrace plenty of collaborators who every carry particular experience. If candidates want companions with particular experience, please establish so inside your proposal submission and we are going to contemplate areas to encourage collaboration amongst totally different candidates to allow end-to-end options
• Articulate options that would allow manufacturing in LMICs
• For candidates concerned with Option B: Please share any non-confidential knowledge sharing that technical readiness stage 3-5 has been met for low-cost manufacturing of HIV, RSV, or malaria antibodies

How to Apply

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

Apply for this Opportunity

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