Improving mAb Purification Process Efficiency

This technical report evaluates the efficiency of monoclonal antibody (mAb) purification processes using mixed-mode resins, specifically Nuvia aPrime 4A and CHT XT Media. The report outlines a comparative analysis between traditional three-step and two-step purification workflows for a Chinese hamster ovary (CHO) cell-expressed trastuzumab biosimilar. It documents the results indicating that the two-step processes yield higher purification efficiency and comparable purity levels, while also effectively removing leached Protein A. The findings suggest that utilizing mixed-mode resins can eliminate a purification unit operation, thereby improving overall yield and process economics. The report includes detailed workflows and performance metrics, such as host cell protein (HCP) and host cell DNA (HCD) removal rates, demonstrating that the two-step processes do not compromise purification quality. The document serves as a guide for researchers and practitioners seeking to enhance mAb purification methodologies.