Waters has introduced a peptide multi-attribute method (MAM) workflow for the Waters BioAccord LC-MS System, enabling drug development, manufacturing and QC scientists to monitor efficacy and safety through the analysis of critical quality attributes (CQAs) of monoclonal antibodies (mAbs) and other protein-based drugs.
The system moves attribute-based monitoring out of centralised MS labs and into the hands of more scientists in regulated and quality control laboratories, who may not have extensive experience operating mass spectrometers. With the peptide MAM workflow on the waters_connect informatics platform, scientists have a single, sensitive multiplexed method to assess the most important attributes of protein-based drugs that enable rapid decision-making for product development, manufacturing and release. The workflow monitors for product variants, product degradation and impurities, and process stability-indicating modifications.
The system pairs the ACQUITY UPLC I-Class Plus, with the ACQUITY RDa Mass Detector featuring SmartMS-enabled usability features. It offers users with varying MS experience an automated set-up and self-diagnosis capability delivered through modern instrument control software and an intuitive user interface, all within a small footprint. In addition to peptide MAM, the system also features workflows for other routine analyses of biotherapeutics: peptide mapping, intact/subunit mass analysis, released glycan profiling and oligonucleotide mass confirmation.
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