A comparison of P rotein A chromatographic stationary phases: Performance characteristics for monoclonal antibody purification

P rotein A chromatography remains the dominant capture step used during the downstream purification of monoclonal antibodies (m A bs). With the recent expiry of the R epligen patent on recombinant P rotein A , a variety of new P rotein A resins have been introduced in the market. Given productivity limitations during downstream processing that have come into sharper focus with the recent increase in cell culture titers for m A bs, the selection of an appropriate P rotein A resin has direct implications on the overall process economics of m A b production. The performance of seven different P rotein A chromatographic resins was compared with respect to static binding capacity and dynamic binding capacity as a function of flow rate. This data was translated into a comparison of productivity (g m A b purified per unit resin volume per unit time) for the seven stationary phases. In addition, elution p H and host cell protein impurity levels after product capture on each of these resins were determined. The current article provides an effective methodology and dataset for the selection of the optimal P rotein A chromatographic resin.