Waters Announces New Method Workflow to Help Meet Regulatory Requirement
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Waters Corporation (NYSE:WAT) has introduced a new 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 BioAccord System moves attribute-based monitoring out of centralized MS labs and into the hands of more scientists in regulated and quality control laboratories who may not have extensive experience operating mass spectrometers,” said Jeff Mazzeo, Ph.D., Vice President – Global Marketing and Scientific Operations, Waters Corporation. “With this new method for the BioAccord System on the waters_connect platform, scientists have a single, sensitive multiplexed method to accurately assess the most important attributes of protein-based drugs that enable rapid decision-making for product development, manufacturing, and release.”
The peptide MAM workflow for the BioAccord System monitors for:
- Product variants
- Product degradation and impurities
- Process stability-indicating modifications
Quality Assistance, a leading contract research organization based in Belgium, uses the Waters BioAccord System as part of a comprehensive portfolio of mass spectrometry services it provides to the pharmaceutical industry.
“Investing in state-of-the-art equipment is essential for remaining at the forefront of analytical sciences,” says Dr. Arnaud Delobel, R&D Director, Quality Assistance. “Our Waters BioAccord System strengthens our ability to meet the needs of customers for robust and reproducible results with full traceability and data integrity from injection to reporting. Automated workflows for intact mass, peptide mapping and monitoring as well as for released N-glycans analysis provide us with reliable results quickly.”
The BioAccord System pairs the ACQUITY™ UPLC™ I-Class Plus with the ACQUITY RDa™ Mass Detectorfeaturing SmartMS™ enabled usability features. The system offers a wide range of users with varying MS experience, industry-leading automated setup 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 BioAccord System also features workflows for other routine analyses of biotherapeutics: peptide mapping, intact/subunit mass analysis, released glycan profiling and oligonucleotide mass confirmation.
waters_connect™: A Single, Platform for LC and LC-MS Applications
waters_connect is a compliant-ready informatics platform enabling scientists to manage functionality of BioAccord System in workstation or laboratory networked deployments. It’s a growing platform of streamlined purpose-built applications that enhances the value that the BioAccord System brings to everyday sample analysis. Providing a complete audit trail for acquisition, processing and reporting of data, waters_connect meets and exceeds expectations for regulatory compliance, while maintaining the highest standards of data integrity.