Method Modernization for Routine Analysis of Biotherapeutics as Part of Lifecycle Management

[ APPLICATION NOTE ] Using Mass Detection as an Orthogonal Technology to Improve Routine Analysis of Biotherapeutics Ximo Zhang, Robert Birdsall, and Ying Qing Yu Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ Improved specificity and confidence for Biotherapeutics…

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 ] Improving Routine Analysis of Insulin Analogues Using the ACQUITY QDa Detector Ximo Zhang, Robert Birdsall, and Yinq Qing Yu Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ A cost-effective solution for improving Since its FDA…