This chapter introduces the necessary concepts to design continuous expression and purification processes for monoclonal antibodies. The operation of a perfusion bioreactor is discussed containing the preparation procedures, the seeding train and the preparation and control of a long-term production run. The downstream processes exploit the benefits of countercurrent chromatography. Their design from batch experiments is presented. The CaptureSMB process is introduced for continuous capturing while for polishing applications the design of the two-column MCSGP process is described. The chapter also puts these processes together in the context of their integration to an end-to-end production process.
Keywords: CaptureSMB; Continuous chromatography; Countercurrent chromatography; Expression; Integrated biomanufacturing; MCSGP; Monoclonal antibody; Perfusion bioreactor; Production; Purification.