Continuous Bioprocessing for Monoclonal Antibody Manufacturing

This technical report examines the economic efficiency and sustainability of end-to-end continuous bioprocessing compared to traditional optimized fed-batch (IO-FB) processes for monoclonal antibody (mAb) production. The analysis focuses on multiproduct facilities that manage both clinical and commercial supply demands. It outlines the significant economic advantages of continuous processing, including a reduction in total annual costs by 12–23% and operational expenses by approximately 8%. Additionally, continuous processes demonstrate sustainability gains, using 57% less plastic and generating 54% lower CO2 emissions. The report also highlights the flexibility and robustness of continuous manufacturing under varying market demands, with potential cost savings increasing to US$50 million in fluctuating scenarios. Despite these advantages, the report notes challenges in adoption due to regulatory compliance and the need for substantial upfront capital investment. Overall, the findings provide a strong foundation for manufacturers to consider transitioning to continuous bioprocessing methodologies.