Advancing biopharmaceutical manufacturing: economic and sustainability assessment of end-to-end continuous production of monoclonal antibodies.

Abstract

Monoclonal antibodies (mAbs) have become essential therapeutics for treating various diseases. The robust, cost-effective, and sustainable production of mAbs is crucial due to their growing clinical and commercial demand. Advances in bioprocessing, such as improved cell lines, perfusion bioreactors, multicolumn chromatography, and automation, can significantly increase productivity, making treatments more accessible. Streamlining the production process also aligns with environmental sustainability by reducing waste and energy consumption. This study quantifies the economic and environmental impacts of incorporating recent advances into end-to-end continuous bioprocessing of mAbs. The results demonstrate that, compared with an optimized best-in-class fed-batch process (with 15 g/l titer and multicolumn chromatography), continuous manufacturing can reduce the total annual production costs, facility footprint, plastic waste, and CO₂ emissions by up to 23%, 51%, 57%, and 54%, respectively, in a multiproduct facility producing clinical and commercial lots. Additionally, uncertainty analysis indicates that these gains are even more substantial under demand fluctuations.