Biosimilars have emerged as a cost-effective alternative to originator biologics, particularly monoclonal antibodies (mAbs), in the treatment of various chronic and life-threatening diseases . With increasing global healthcare demand and patent expirations of major biologics, the development of efficient, scalable, and regulatory-compliant biosimilar manufacturing platforms has become critical . A central component of downstream processing for mAbs is Protein A affinity chromatography, known for its high selectivity and ability to deliver high-purity products in a single step .However, selecting the most suitable Protein A resin is crucial to ensure optimal performance, robustness across batches, and economic feasibility in large-scale production. This study aims to evaluate and compare the performance of commercially available Protein A resins—such as MabSelect SuRe™, Amsphere A3™, and Praesto Jetted A50™—in terms of dynamic binding capacity, product recovery, host cell protein removal, and cleaning cycle tolerance. Using a platform process involving a CHO-expressed biosimilar antibody, each resin was assessed through chromatographic runs and analytical assays including ELISA, SDS-PAGE, and HPLC. Results revealed substantial variation in binding efficiency and reusability, with certain resins showing superior CIP resistance and process economy. These findings contribute to establishing a platform-based approach for biosimilar purification, aiding biopharmaceutical manufacturers in reducing development timelines and operational costs while maintaining regulatory compliance.

Biosimilars, Platform Process Development, Protein A Chromatography, Monoclonal Antibodies, Resin Screening, CHO Cells, Affinity Purification, Downstream Processing, mAb Purification, Biopharmaceutical Manufacturing