USP Monograph mAb SEC Method Robustness on the XBridge Premier Protein SEC Column

Application Note Improved Separation Performance of Monoclonal Antibody and Antibody Drug Conjugates Using Waters XBridge Premier Protein SEC 250 Å, 2.5 µm Column Kenneth D. Berthelette, Jennifer M. Nguyen, Lavelay Kizekai, William J. Warren, Steve Shiner Waters Corporation Abstract Monoclonal…

Application Note Rapid Size Variant Analysis of Monoclonal Antibodies Using UPLC™ and HPLC Compatible MaxPeak™ Premier Protein SEC Columns Stephan M. Koza, Ying Qing Yu Waters Corporation Abstract High-throughput and rapid size-exclusion chromatography (SEC) methods can be useful to support…

Application Note MaxPeak Premier Protein SEC 250 Å Column Lifetimes at Physiological pH for Polysorbate (Tween) Formulated Biosimilar Monoclonal Antibodies Stephan M. Koza, Hua Yang, Ying Qing Yu Waters Corporation Abstract Self-associated or aggregated protein impurities in therapeutics is a…

Application Note Evaluating the Ruggedness of the Alliance™ iS Bio HPLC System for SEC Separations Pawel Bigos, Robert E. Birdsall, Karen Nyholm Waters Corporation Abstract Biopharmaceutical companies are often progressing several monoclonal antibody (mAb) drug candidates to mitigate the risks…