“Most of the global population as of today cannot afford to take or avail of these best-in-class therapeutics.” – Anurag Rathore, PhD, professor, Department of Chemical Engineering, IIT Delhi
$10-per-Gram Antibodies Could Compete With Vaccines Against Infectious Disease, Says IIT Delhi’s Anurag Rathore
Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team cuts monoclonal antibody costs without cutting purification steps, and why the $10-per-gram target could make antibodies viable for infectious disease and global access.
Bringing monoclonal antibody (mAb) manufacturing costs down to about $10 per gram raises two questions: whether quality can be protected along the way, and what such a drop would change for patients. In the second part of a three-part interview with BioPharm International®, Anurag Rathore, PhD, professor in the Department of Chemical Engineering at the Indian Institute of Technology (IIT) Delhi, who spoke this week at
“When I say make process more efficient, we are not making it efficient by just dropping some process steps or doing less of purification or anything,” Rathore said. “Essentially, our process is what a conventional process is.”
In the
Can manufacturers cut antibody costs this far without compromising quality?
According to Rathore, quality concerns weigh most heavily on teams that are changing the fundamentals of production. A developer adopting a new expression system, for example, must determine how it affects the antibody’s critical quality attributes, such as glycan composition, and whether any change would show up in clinical trials or affect patients. “You have to create data to make sure that this is not what will happen,” he said.
His team’s project, funded through a Gates Foundation and LifeArc program, takes a more conventional route. The process keeps the standard sequence of mammalian cell culture, clarification, Protein A chromatography, cation exchange chromatography, anion exchange chromatography, and viral filtration. Because the product goes through the same purification it does in conventional processes today, Rathore said, “the concern with respect to quality is not really there.”
The scale of the challenge is significant. According to Rathore, typical mAb manufacturing costs range from $80 to $150 per gram in Europe and North America, and the best figures he has seen anywhere are around $45 per gram. “Going from this to $10 a gram is a significant leap,” he said.
That leap matters because current prices put these therapies out of reach for many patients. Rathore pointed to a study his group published on the global affordability of mAb products, which found that even in the United States, many patients cannot afford best-in-class antibodies unless insurance covers the cost. The gap widens across much of Asia, Africa, and South America. “Even today, these things are not really affordable for the vast majority of the population,” he said.
Rathore also explained why he believes the Gates Foundation chose $10 per gram rather than another figure. “They could have picked five. They could have picked 20, right?” he said. Based on the foundation’s own assessment, he said, $10 per gram is the point at which mAbs could compete with traditional approaches for communicable diseases. Today, vaccines are far cheaper than antibodies, so health systems naturally favor them. “But if you can take mAbs to $10 a gram,” he said, “there is a possibility that mAb products start coming up for effectively dealing with infectious disease.”
About the Speaker
Anurag Rathore, PhD, professor, Department of Chemical Engineering, IIT Delhi
Anurag Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi. He earned his PhD in chemical engineering from Yale University and worked for about 12 years at Pfizer and Amgen before joining IIT Delhi. His research focuses on the analytical characterization and manufacturing of biotherapeutic products, with an emphasis on making biologics more affordable and accessible worldwide.
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