A Case Study: 3-step Process for Efficient mAb Purification

This study showcases a portfolio of commercially available biopharmaceutical chromatography resins designed for the efficient purification of monoclonal antibodies. A 3-step purification process has been implemented which showed effective removal of the main contaminants, low ligand leakage, and high yields over the entire process. Eshmuno® A affinity chromatography resin was evaluated as the first step in the process. The Protein A elution pool was further purified using cation exchange chromatography. Two cation exchange resins with different selectivities were compared. The final purification step consisted of anion exchange chromatography. The product yield, HCP removal, leached Protein A removal, and aggregate content were evaluated at each step in the process. Final process yields ranged from 74 to 81 percent. This work highlights the comparable purification capabilities of a panel of EMD Millipore resins designed for efficient mAb purification.