Process Optimization for High-Purity mAb Recovery

This technical report outlines the optimization process for the recovery of monoclonal antibodies (mAbs) using TOYOPEARL Super A resin. The document details the challenges faced during high-load mAb capture on Protein A resin, specifically issues related to high host cell protein (HCP) levels and low recovery rates. It presents a systematic approach to enhance recovery and reduce impurities through optimized wash and elution steps. The report provides specific methodologies, including the evaluation of wash buffer additives such as NaCl and arginine-HCl, and their impact on recovery and HCP reduction. Results demonstrate that the inclusion of 150 mmol/L NaCl in the wash buffer significantly improves the balance between recovery and HCP clearance. Additionally, the report discusses elution buffer additives, highlighting glycerol's effectiveness in increasing recovery rates without compromising purity. The findings are supported by experimental data, including dynamic binding capacity measurements and recovery rates under various conditions.