At the BioProcess International Europe event, industry expert Jean-Marc Cappia emphasized the transformative impact of process intensification on monoclonal antibody (mAb) manufacturing, highlighting significant cost reductions and efficiency improvements.
Cappia outlined how the integration of advanced technologies like single-use systems, perfusion bioreactors, and continuous capture platforms has driven down production costs from approximately $500 per gram to under $100 per gram in the last decade. Some companies have even achieved costs below $50 per gram, suggesting that the industry is moving toward a more efficient and cost-effective production model.
Innovations in upstream processing include the transition from large stainless-steel tanks to single-use fed-batch bioreactors, significantly increasing yields. The introduction of perfusion technology has further enhanced productivity, allowing for titers to reach up to 25 grams per liter. Meanwhile, downstream processing is catching up, utilizing rapid cycling membrane chromatography to enhance efficiency and reduce costs. The adoption of multi-column chromatography techniques has also improved resin utilization and minimized buffer use.
To achieve even lower production costs, Cappia stressed the need for a holistic approach that integrates upstream and downstream processes. This involves adopting continuous bioprocessing methods and advanced automation technologies. While traditional stainless-steel biomanufacturing remains essential for large-volume products, companies are increasingly investing in intensified processes for smaller-scale, more flexible production. The future of mAb manufacturing lies in a seamless integration of technologies that enable real-time control and automation, paving the way for more sustainable practices.