BMGF Grand Challenges – Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing

Funding from the Bill & Melinda Gates Foundation Grand Challenges initiative to reduce the costs of monoclonal antibody (mAb) manufacturing through transformational innovations and solutions.

Founded in 1997, the Bill & Melinda Gates Foundation (BMGF) is a charitable organisation that seeks to improve the health and wellbeing of people in developing countries and within the US, and works to ensure that all people lead healthy, productive lives.

The BMGF Grand Challenge (GC) initiative seeks to engage innovators from around the world to solve the most pressing challenges in global health and development. This Innovations for Exceptionally Low-Cost Monoclonal Antibody (mAb) Manufacturing GC competition aims to source and seed innovations and accelerate the development of transformational solutions to reduce the cost of mAb production to a target of $10 per gram. For this call, BMGF is working in partnership with LifeArc, a UK-based medical research charity.

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 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 to the order of hundreds of milligrams. In order to improve mAb affordability in low and middle-income countries, there needs to be a final drug substance cost-of-goods of $10 per gram.

To reach this goal, innovative approaches are required from a wide range of scientific and engineering disciplines. While those in the biopharmaceutical field are already engaged in the challenge of reducing mAb manufacturing costs, there is tremendous potential for breakthroughs 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, BMGF believes it is possible to achieve this ambitious goal.

There are two funding options:

• Option A – Proof-of-Concept: To develop proof-of-concept for manufacturing platforms that produce monoclonal antibodies at a final drug substance cost-of-goods of $10 per gram. The goal is to catalyse and accelerate multiple, diverse, innovative bioprocessing approaches that hold the promise of low-cost mAbs. The primary outputs of this challenge will be: development of a conceptual facility design; and 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 organisation. BMGF is partnering with LifeArc on this option. Option A applicants may be eligible for further support in a follow-on phase of work.
• Option B – Operationalisation and Economic Viability: For applicants 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 that have existing data meeting Technical Readiness Levels 3-5 are invited to share their solution for production of a monoclonal antibody at a final drug substance cost-of-goods of $10 per gram. BMGF is not partnering with LifeArc on this option.

Applicants can apply with solutions meeting the criteria for either Option A or Option B, but should not submit entries to both options.

Projects should rethink existing methods of working and push the boundaries of current technology by harnessing disruptive innovations, possibly from parallel industries, and identify process improvements to reduce manufacturing costs.