Monoclonal Antibodies Production Platforms: An Opportunity Study of a Non‐Protein‐A Chromatographic Platform Based on Process Economics

Monoclonal antibodies currently dominate the biopharmaceutical market with growing sales having reached 80 billion USD in 2016. As most top‐selling mAbs are approaching the end of their patent life, biopharmaceutical companies compete fiercely in the biosimilars market. These two factors present a strong motivation for alternative process strategies and process optimization. In this work a novel purification strategy for monoclonal antibodies comprising phenylboronic acid multimodal chromatography for capture followed by polishing by ion‐exchange monolithic chromatography and packed bed hydrophobic interaction chromatography is presented and compared to the traditional protein‐A‐based process. Although the capital investment is similar for both processes, the operation cost is 20% lower for the novel strategy. This study shows that the new process is worthwhile investing in and could present a viable alternative to the platform process used by most industrial players. Biopharma industry is dominated by monoclonal antibodies which are expensive to produce, in part due to their purification which is centered in protein‐A affinity chromatography. In this study, the authors use process simulation and economical analysis to show that phenylboronate‐ and monolithic anion exchange‐chromatography compete with the established strategy. Capital investment is similar for both processes but operation costs are 20% lower for the illustrated process.