Abstract:
Protein A affinity chromatography remains the predominant capture platform for monoclonal antibody (mAb) purification; rising mAb titers require resins that combine high capacity, recovery, impurity clearance, and chemical resistance.
TOYOPEARL® Super A is a next-generation recombinant Protein A resin engineered for high dynamic binding capacity (DBC) and alkaline stability. Here, we demonstrate the optimization of bind, wash, and elution conditions on a TOYOPEARL Super A prepacked column using trastuzumab as a model mAb.
DBC remains high across load concentrations. Wash optimization studies demonstrate wash buffer additives sodium chloride and arginine improve host cell protein (HCP) clearance while preserving recovery; extending the NaCl wash further reduces impurities without compromising yield. We identify glycerol as a safe, recovery-enhancing elution additive. The optimized process achieves >97% recovery, low Protein A leaching, greater HCP clearance, and robust performance.
