INTEGRATED POLISHING STEPS FOR MONOCLONAL ANTIBODY PURIFICATION

Monoclonal antibodies (mAbs) have become the most important therapeutic modality in the biotechnology industry. This chapter presents an overview of the polishing steps most frequently used in antibody manufacturing and discusses the considerations to be kept in mind while integrating these steps into the overall purification scheme. Additional considerations need to be kept in mind while integrating the polishing steps into a downstream process. One key factor is overall process productivity. Apart from productivity, other factors that influence the choice and number of polishing steps, their mode of operation, and their placement, include key impurities that need to be removed, how difficult they are to separate, final product purity constraints, optimal process flow with the fewest operational steps, and how easy they are to fit in the manufacturing facility. Some of the philosophies concerning the integration of polishing steps into a manufacturing process are illustrated through the case studies.