MONITORING PRODUCT ATTRIBUTES IN BIOPHARMACEUTICAL DEVELOPMENT AND QC WITH LC/MS

MONITORING PRODUCT ATTRIBUTES IN BIOPHARMACEUTICAL DEVELOPMENT AND QC WITH LC/MS Scott J. Berger, Liuxi Chen, Henry Shion, Min Du, Sean M. McCarthy, Kenji Hirose and Ying Qing Yu Biopharmaceutical Business Team, Waters Corporation Milford, MA and Tokyo, Japan INTRODUCTION RESULTS…

[ APPLICATION NOTEBOOK ] Multi-Attribute Methods for Biopharmaceutical Analysis Application Notes [ APPLICATION NOTEBOOK ] Introduction The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years. The ability…

BIOPHARMACEUTICAL PLATFORM SOLUTION Key Applications TABLE OF CONTENTS Biopharmaceutical Platform Solution with UNIFI: Key Applications Intact Protein MS Analysis I Peptide Mapping I Released Glycan Analysis I Bioseparations Biotherapeutic proteins – such as monoclonal antibodies (mAbs), biosimilars, and antibody drug…

Application Note Applying Peptide Mapping and MultiAttribute Method (MAM) Workflow for Biosimilar mAb Drug Products Comparison on the Xevo™ G3 QTof Platform Kellen DeLaney, Samantha Ippoliti, Lisa Reid, Owen Cornwell, Ying Qing Yu, Emma Harry, Mark Towers Waters Corporation Abstract…