Modernization of Compendial Size Exclusion Chromatography Aggregation Analysis Methods in Compliance with Updates to USP General Chapter <129>

Application Note Modernizing Compendial SEC Methods for Biotherapeutics Using the Alliance™ iS Bio HPLC System Pawel Bigos, Robert E. Birdsall, Karen Nyholm Waters Corporation Abstract The process of method modernization, which involves integrating advancements in system and column technology for…

METHOD MODERNIZATION OF COMPENDIAL METHODS USING USP <621> WITH A NEXT-GENERATION HPLC SYSTEM Pawel Bigos, Duanduan Han, Xiangsha Du, Robert Birdsall, Karen Nyholm Waters Corporation 0.0000 10.0 0.0030 0.0025 0.0025 System Column Inj. Vol. Flow Rate Run Time Mobile Phase…

MODERNIZING BIOTHERAPEUTIC COMPENDIAL METHODS WITH A NEXT-GENERATION HPLC SYSTEM Pawel Bigos, Duanduan Han, Xiangsha Du, Robert Birdsall, Andrea Hoehnel, Karen Nyholm Waters Corporation INTRODUCTION RESULTS AND DISCUSSION As the field of analytics continues to evolve, methods guided by regulatory general…

[ APPLICATION NOTE ] Impact of LC System Dispersion on the Size-Exclusion Chromatography Analysis of Monoclonal IgG Antibody Aggregates and Fragments: Selecting the Optimal Column for Your Method Stephan M. Koza, Corey E. Reed, and Weibin Chen Waters Corporation, Milford,…