The Gates Foundation has launched a $13.5 million initiative to dramatically reduce monoclonal antibody manufacturing costs, potentially transforming global access to these life-saving treatments. The ambitious program aims to slash production costs from the current $50-100 per gram to just $10 per gram, making monoclonal antibodies accessible to millions of people in resource-limited settings worldwide.
Revolutionary Manufacturing Approaches
Seven groundbreaking projects have been selected to tackle the main cost drivers in monoclonal antibody production. The initiative combines $5 million in joint funding from LifeArc and the Gates Foundation, with an additional $8.5 million awarded through separate Gates Foundation programs, including a $3.1 million grant to Rensselaer Polytechnic Institute.
Professor Todd Przybycien from RPI's Department of Chemical and Biological Engineering will focus on optimizing downstream purification processes. "Optimization and intensification of the downstream purification process offer the exciting possibility of breaking through to the $10/g overall target," Przybycien said. His team will advance a precipitation-based process developed in collaboration with Penn State.
Innovative Technologies Target Cost Barriers
The funded projects represent diverse technological approaches to cost reduction. Massachusetts Institute of Technology researchers are developing a continuous flow platform called SCoRe (Self-Scaling Continuous Recovery for Exceptionally low-cost antibodies) that replaces expensive resin-based chromatography with engineered binding agents and membrane technologies.
Duke University's project pioneers self-purifying antibodies using engineered fusion proteins with elastin-like polypeptides, potentially reducing costs by up to 90% while eliminating the need for traditional chromatography. Meanwhile, VTT Technical Research Centre of Finland is exploring the use of Trichoderma reesei fungal cells as an alternative to expensive mammalian cell production systems.
"Fungi are exceptional protein-making machines by nature and biotechnology has leveraged this remarkable feature for decades to produce industrial enzymes, and food proteins," said Dr. Antti Aalto from VTT. "Our goal is to apply the same principle to antibody production as a solution to achieve equity in global access to biopharmaceuticals."
Addressing Global Health Disparities
The cost reduction initiative directly addresses stark global health inequities. Africa holds only 1% of the global monoclonal antibody market despite carrying a high burden of diseases that these treatments could prevent and treat. Monoclonal antibodies have proven effective against infectious diseases like COVID-19, autoimmune disorders, and certain cancers, but current market prices effectively exclude millions from access.
"Africa holds only 1 per cent of the global mAb market, but carries a high burden of diseases they could help prevent and treat," said Ghada Zoubiane, Head of Global Health – Infection at LifeArc. "Working with the Gates Foundation to support these projects is a pivotal step towards realising our ambition of developing affordable and accessible innovations for everyone, especially the communities most impacted by infectious diseases."
Malaria as First Target Application
The team's initial focus will be developing a monoclonal antibody to treat malaria, an infectious disease that kills more than half a million people annually, primarily in Africa. Several projects specifically target the antimalarial antibody MAM01, including Johns Hopkins University's fungal fermentation platform and North Carolina State University's all-membrane purification system.
Bondi Bio and UNSW Sydney are taking an even more innovative approach, developing the photosynthetic cyanobacterium Synechococcus as a novel production host for MAM01 antibodies. This platform could leverage natural photosynthesis to further reduce production costs.
Manufacturing Innovation Potential
The initiative represents a significant departure from traditional biomanufacturing approaches. Current monoclonal antibody production relies heavily on expensive mammalian cell cultures and complex purification processes that drive up costs. The funded projects explore alternatives including continuous processing platforms, fungal expression systems, and membrane-based technologies that could fundamentally reshape the industry.
"We are excited by the opportunity to demonstrate that there are existing solutions developed by industry and academic partners that can significantly reduce cost of goods and accelerate timelines," said Kelvin Lee, NIIMBL Institute Director, whose organization leads the $10.5 million Gates Grand Challenge program.
The Gates Grand Challenge was established in honor of Dr. Steve Hadley, who championed reducing monoclonal antibody costs to make them affordable in low- and middle-income countries. If successful, these projects could enable large-scale antibody production at small, local sites, dramatically improving global access to these critical therapeutics.
