Modernizing Compendial SEC Methods for Biotherapeutics Using the Alliance™ iS Bio HPLC System

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…

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…

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…

Application Note Leveraging the Alliance™ iS Bio HPLC System as a Modern HPLC for Peptide Drug Substances Analysis in QC Environments Duanduan Han, Robert E. Birdsall, Karen Nyholm Waters Corporation Abstract The Alliance iS Bio HPLC System with MaxPeak™ High…