Three-Step Monoclonal Antibody Purification Processes Using Modern Chromatography Media

This application note describes a monoclonal antibody (MAb) purification process using the expanded MAb purification toolbox of GE Healthcare’s Life Sciences business, covering modern chromatography media (resins) for standard and challenging purification tasks. The most established approach for purifying MAbs is a three-step process, where the initial capture step using a protein A medium is followed by two polishing steps using cation- exchange (CIEX) and anion-exchange (AIEX) media (Figure 1a). However, for more challenging MAb purifications, an expanded MAb purification toolbox is beneficial. Here, a multimodal AIEX medium was used as an alternative in final polishing of a MAb with low monomer stability (Figure 1b). Using the described approach, the set criteria for the polishing steps were achieved, with a recovery of >90% over each step and an aggregate content <1% in the final product.

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