Rapid Purification Strategies for Monoclonal Antibodies: A Case Study

ABSTRACT Monoclonal antibodies (mAbs) are widely used in drug development for their precise targeting and lower adverse effects. Market competition drives demand for more efficient mAb production processes. We developed a mAbs purification platform integrating protein A membrane chromatography with sequential anion/cation exchange. Compared with conventional protein A column chromatography (HiTrap MabSelect PrismA), protein A membrane chromatography (HiTrap Fibro PrismA) achieved a 96% reduction in process time (7.5 vs. 190 min) with similar product quality. A tandem system (Eshmuno CP‐FT + Natrix Q Micro) showed robust performance at high loads (up to 1000 g/L). Specifically, this system reduced high molecular weight impurities from 1.9% to 0.2% and host cell protein levels from 630.4 to 19.77 ppm, while maintaining a recovery yield exceeding 90%. Combined rapid affinity membrane and high‐capacity tandem exchange steps reduced medium costs by 11.8%. This platform demonstrates high efficiency for mAbs purification workflows.