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Monoclonal Antibodies Research

Bill and Melinda Gates Foundation

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).

Specialties

Immunology

Others

Infectious Diseases

Eligibility Requirements

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

Sponsor Details

Sponsor Institute/Organizations: Bill and Melinda Gates Foundation

Sponsor Type: Corporate/Non-Profit

Address: 500 Fifth Avenue North, Seattle, WA 98109

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