Rapid Size Variant Analysis of Monoclonal Antibodies Using UPLC™ and HPLC Compatible MaxPeak™ Premier Protein SEC Columns

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 Rapid SEC-UV Analysis of Monoclonal Antibodies Using Ammonium Acetate Mobile Phases Stephan M. Koza, Albert H. W. Jiang, Ying Qing Yu Waters Corporation Abstract A 4 minute high resolution size-exclusion with UV absorbance detection (SEC-UV) method for the…

Application Note USP Monograph mAb SEC Method Robustness on the XBridge Premier Protein SEC Column Hua Yang, Stephan M. Koza, Ying Qing Yu Waters Corporation Abstract Size-exclusion chromatography (SEC) has been widely used for size-based impurity analysis. We show here…

Application Note Modern Size-Exclusion Chromatography Separations of Biosimilar Antibodies at Physiological pH and Ionic Strength Stephan M. Koza, Hua Yang, Ying Qing Yu Waters Corporation Abstract The state of protein derived self-associated, aggregated, and fragmented impurities in therapeutics are critical…