Therapeutic antibodies will always be too expensive for low- and middle-income countries, unless manufacturers embrace more cost-efficient production tech.
So says Peter Gardner, scientific director at U.K. charity LifeArc and co-author of a new study which argues that manufacturing innovation is needed to bring down costs.
“Access to monoclonal antibodies (mAbs) varies significantly across regions, with low- and middle-income countries (LMICs) facing the greatest challenges due to high production costs. Manufacturing expenses, often exceeding $50–$100 per gram, make these life-saving treatments unaffordable in many settings.
“This creates both a market barrier—where existing mAbs are too expensive to produce and distribute—and a funding barrier, where there’s insufficient investment in developing mAbs for diseases prevalent in LMICs, such as hemorrhagic fevers and mother-to-child transmission of HIV,” he tells GEN.
Multiple factors determine mAb prices with R&D and marketing expenditure, as well as developers’ profit margins, being the key components. Manufacturing costs, according to recent research, can account for anywhere between 1% and 25% of the list price.
Reducing R&D spending and margins is complex, involving company-wide decision-making. Lowering manufacturing costs could, by contrast, be much more straightforward with alternative regents and consumables, Gardner says.
“Culture media and protein A are the costliest consumables, although buffers and membranes also play a part. There are innovative efforts underway to reduce and replace these without compromising on quality.
“Some weird and wonderful options for upstream expression include meal worms, tobacco, fungi, and hen’s eggs, although this is actually not so weird, given that influenza and Yellow fever vaccines are made in eggs,” he said.
Downstream processing operations—capture, filtration, etc.—could also be more cost efficient, according to Gardner.
“Continuous precipitation and liquid/liquid phase separation offer potential solutions. In addition, these approaches use pH changes that may reduce the need for viral filtration and chromatography polishing steps, reducing time and consumables further.”
Moving away from batch-mode production and using higher-yield cell lines are also options for mAb makers looking to reduce production costs, Gardner says.
“Recent approaches, including continuous perfusion, offer lower costs, and there probably remains an optimization opportunity to fully use continuous perfusion for cheaper products.
“In the medium-term, higher yield cell lines, optimized with low-cost, simple culture media would help significantly. We are getting closer toward success with microbial cell lines shown by recent top-line results from a successful Phase I clinical trial of a subunit vaccine expressed by filamentous fungi,” he says.
Combining innovative techniques and technologies with wider efforts to increase manufacturing capacity in LMICs would bring down costs and allow more patients to access mAbs, according to Garner.
“Game-changing reductions on cost will require upstream and downstream innovations coupled together; a reimagining of the traditional mAb production process. I believe that investing in innovative technologies and public private partnerships that engage industry are critical to delivering this.”
“Somebody, at some point, needs to take on the risk of developing a mAb into the clinic produced by an innovative, novel manufacturing method. This needs to be coupled with the growing interest and demand in LMICs for self-sustainable production,” he says.
The post Cutting mAb Costs and Boosting Access in Low- and Middle-Income Countries appeared first on GEN - Genetic Engineering and Biotechnology News.
So says Peter Gardner, scientific director at U.K. charity LifeArc and co-author of a new study which argues that manufacturing innovation is needed to bring down costs.
“Access to monoclonal antibodies (mAbs) varies significantly across regions, with low- and middle-income countries (LMICs) facing the greatest challenges due to high production costs. Manufacturing expenses, often exceeding $50–$100 per gram, make these life-saving treatments unaffordable in many settings.
“This creates both a market barrier—where existing mAbs are too expensive to produce and distribute—and a funding barrier, where there’s insufficient investment in developing mAbs for diseases prevalent in LMICs, such as hemorrhagic fevers and mother-to-child transmission of HIV,” he tells GEN.
Manufacturing costs
Multiple factors determine mAb prices with R&D and marketing expenditure, as well as developers’ profit margins, being the key components. Manufacturing costs, according to recent research, can account for anywhere between 1% and 25% of the list price.
Reducing R&D spending and margins is complex, involving company-wide decision-making. Lowering manufacturing costs could, by contrast, be much more straightforward with alternative regents and consumables, Gardner says.
“Culture media and protein A are the costliest consumables, although buffers and membranes also play a part. There are innovative efforts underway to reduce and replace these without compromising on quality.
“Some weird and wonderful options for upstream expression include meal worms, tobacco, fungi, and hen’s eggs, although this is actually not so weird, given that influenza and Yellow fever vaccines are made in eggs,” he said.
Downstream processing operations—capture, filtration, etc.—could also be more cost efficient, according to Gardner.
“Continuous precipitation and liquid/liquid phase separation offer potential solutions. In addition, these approaches use pH changes that may reduce the need for viral filtration and chromatography polishing steps, reducing time and consumables further.”
Continuous benefits
Moving away from batch-mode production and using higher-yield cell lines are also options for mAb makers looking to reduce production costs, Gardner says.
“Recent approaches, including continuous perfusion, offer lower costs, and there probably remains an optimization opportunity to fully use continuous perfusion for cheaper products.
“In the medium-term, higher yield cell lines, optimized with low-cost, simple culture media would help significantly. We are getting closer toward success with microbial cell lines shown by recent top-line results from a successful Phase I clinical trial of a subunit vaccine expressed by filamentous fungi,” he says.
Reimagining mAbs
Combining innovative techniques and technologies with wider efforts to increase manufacturing capacity in LMICs would bring down costs and allow more patients to access mAbs, according to Garner.
“Game-changing reductions on cost will require upstream and downstream innovations coupled together; a reimagining of the traditional mAb production process. I believe that investing in innovative technologies and public private partnerships that engage industry are critical to delivering this.”
“Somebody, at some point, needs to take on the risk of developing a mAb into the clinic produced by an innovative, novel manufacturing method. This needs to be coupled with the growing interest and demand in LMICs for self-sustainable production,” he says.
The post Cutting mAb Costs and Boosting Access in Low- and Middle-Income Countries appeared first on GEN - Genetic Engineering and Biotechnology News.