Fed-batch and batch bioprocessing still dominate monoclonal antibody (mAb) production, but that must change if mAbs are to become economically viable therapeutic options. Current production techniques are too expensive, hard to scale, and inconsistent batch-to-batch, all of which make it challenging for mAb manufacturers to ensure product quality, shorten time-to-market, and reduce production costs.
“Despite their therapeutic potential, mAbs remain inaccessible to many patients, particularly in low- and middle-income countries, with current costs stagnating at $50–100 per gram. To achieve global accessibility, we need to reduce these costs to around $10 per gram,” Ranjit Ranbhor, PhD, scientific advisor at the intellectual property law firm Pergament & Cepeda, tells GEN. “The Gates Foundation recently called for proposals specifically addressing this issue.”
Ranbhor’s recent literature review shows that single-use continuous (perfusion) bioprocessing can reduce mAb production costs by as much as 35%. That’s compared to batch processing and annual mAb production quantities between 100 and 500 kg.
Such savings are scale-dependent, however, and shrink to roughly 10% when production volumes reach one to three metric tons. That, Ranbhor explains, is because many parallel, continuous processing systems are needed.
The most economical approaches for various-sized batches are:
“Hybrid approaches, combining single-use and traditional systems, can offer optimal solutions for many manufacturers,” he reports. Such facilities “…reach profitability 2 to 2.5 years earlier than traditional stainless-steel facilities.” Flexibility is a key advantage with hybrid systems and, of the multiple possible configurations, a 3 x 2,000-L bioreactor system with pooled harvesting appears to be the most cost-effective hybrid setup, he reports.
Ranbhor also indicates that switching to continuous manufacturing causes “no appreciable effect on final drug substance properties,” and “drastically cuts buffer consumption.” That suggests the possibility of using perfusion bioculture at any point in the processing. He also cites research showing that existing fed-batch infrastructure can be adapted to continuous manufacturing with a minimum investment.
To further reduce operating expenses, he suggests optimizing media to improve mAb production, harmonizing upstream and downstream operations, and developing a scale-based cost-benefit analysis as a framework for choosing technology. “Integrating advanced PAT and real-time monitoring systems has proven essential in maximizing the benefits of these approaches,” he reports. Embracing quality by design adds further benefits.
A comprehensive program should include a “media development, process integration, and technology selection framework for manufacturers to achieve significant cost reductions while maintaining product quality and manufacturing efficiency,” he notes. The caveat is that, for maximum effectiveness, strategies must be designed for a manufacturer’s specific requirements and manufacturing objectives.
“The future will be defined by intelligent manufacturing systems, where AI algorithms continuously optimize production parameters in real-time,” Ranbhor predicts.
The post Single-Use Continuous Bioprocessing Can Reduce mAb Production Costs appeared first on GEN - Genetic Engineering and Biotechnology News.
“Despite their therapeutic potential, mAbs remain inaccessible to many patients, particularly in low- and middle-income countries, with current costs stagnating at $50–100 per gram. To achieve global accessibility, we need to reduce these costs to around $10 per gram,” Ranjit Ranbhor, PhD, scientific advisor at the intellectual property law firm Pergament & Cepeda, tells GEN. “The Gates Foundation recently called for proposals specifically addressing this issue.”
Ranbhor’s recent literature review shows that single-use continuous (perfusion) bioprocessing can reduce mAb production costs by as much as 35%. That’s compared to batch processing and annual mAb production quantities between 100 and 500 kg.
Scale-dependent savings
Such savings are scale-dependent, however, and shrink to roughly 10% when production volumes reach one to three metric tons. That, Ranbhor explains, is because many parallel, continuous processing systems are needed.
The most economical approaches for various-sized batches are:
- Less than 100 kg, fed-batch
- 100–500 kg, continuous processing
- 500–1,000 kg, hybrid processing
- Beyond 1,000 kg, strategies depend on the product portfolio and facility flexibility
“Hybrid approaches, combining single-use and traditional systems, can offer optimal solutions for many manufacturers,” he reports. Such facilities “…reach profitability 2 to 2.5 years earlier than traditional stainless-steel facilities.” Flexibility is a key advantage with hybrid systems and, of the multiple possible configurations, a 3 x 2,000-L bioreactor system with pooled harvesting appears to be the most cost-effective hybrid setup, he reports.
Ranbhor also indicates that switching to continuous manufacturing causes “no appreciable effect on final drug substance properties,” and “drastically cuts buffer consumption.” That suggests the possibility of using perfusion bioculture at any point in the processing. He also cites research showing that existing fed-batch infrastructure can be adapted to continuous manufacturing with a minimum investment.
To further reduce operating expenses, he suggests optimizing media to improve mAb production, harmonizing upstream and downstream operations, and developing a scale-based cost-benefit analysis as a framework for choosing technology. “Integrating advanced PAT and real-time monitoring systems has proven essential in maximizing the benefits of these approaches,” he reports. Embracing quality by design adds further benefits.
A comprehensive program should include a “media development, process integration, and technology selection framework for manufacturers to achieve significant cost reductions while maintaining product quality and manufacturing efficiency,” he notes. The caveat is that, for maximum effectiveness, strategies must be designed for a manufacturer’s specific requirements and manufacturing objectives.
“The future will be defined by intelligent manufacturing systems, where AI algorithms continuously optimize production parameters in real-time,” Ranbhor predicts.
The post Single-Use Continuous Bioprocessing Can Reduce mAb Production Costs appeared first on GEN - Genetic Engineering and Biotechnology News.