Waters introduced an expansion of its Biopharmaceutical Platform Solution with UNIFI, new ACQUITY UltraPerformance LC (UPLC) CSH130 C18 and XSelect HPLC CSH130 C18 columns for peptide mapping, and three GlycoWorks kits for glycan labeling and sample preparation. These new products further progress routine biotherapeutic analysis, particularly for glycoproteins that require analysis of glycan modifications in addition to detailed protein and peptide level structural analysis. Armed with more rapid and accurate glycosylation knowledge throughout the development and manufacturing process, biopharmaceutical companies can gain a greater degree of control over the critical quality attributes of their molecules. Such capabilities are in-line with increasing regulatory expectations aimed at guaranteeing safe and efficacious biotherapeutics.
The Biopharmaceutical Platform Solution brings together UPLC/MS characterization technology with the UNIFI Scientific Information System that was first developed for intact protein mass analysis, peptide mapping, and supporting general bio-separations. Waters extended the solution’s reach to support a mix of quadrupole time-of-flight (Q-Tof) MS and optical detection instruments within a networked laboratory workgroup. The ability to deploy UNIFI-based systems within regulated or non-regulated laboratory environments provides biopharmaceutical companies the flexibility to employ high resolution UPLC bioseparations and high performance mass analysis across the entirety of their development and quality organizations.
The Glycan application workflow expands the platform’s capabilities to support routine assignment and profiling of released glycans using fluorescence detection. The combination of high performance UPLC HILIC (hydrophilic interaction chromatography) separations, Waters’ calibration standards and reagents, and access to the NIBRT/Waters GlycoBase 3+ UPLC glycan unit reference database enables confident glycan assignments, quantification, and profiling.
The Biopharmaceutical Platform Solution with UNIFI now features:
• ACQUITY UPLC H-Class and the H-Class Bio System featuring a bio-inert flow path and quaternary solvent management with Auto-Blend Plus™ Technology, for flexibility in executing high-resolution bioseparations;
• Waters Peptide, Protein, and Glycan Separation Technology Columns, engineered with the selectivity to leverage the characteristics of biomolecules and QC-tested to ensure consistent results;
• Waters Analytical Standards and Reagents for biopharmaceutical analysis, enabling SEC (size exclusion chromatography) and released glycan separation calibration, and system check standards for intact mass, peptide map, and released glycan workflows;
• Xevo G2-S Q-Tof Mass Spectrometer, a highly sensitive exact-mass quantitative and qualitative benchtop MS system featuring Waters’ proprietary StepWave™ ion optics technology, a unique, off-axis ion source technology that delivers robust, reproducible, class-leading sensitivity to mass spectrometry;
• UNIFI Scientific Information System, an interactive, workflow-driven data platform for flexible instrument control, advanced data processing, and comprehensive reporting, with GxP laboratory compatibility that enables routine deployment in workstation or workgroup laboratory configurations;
• GlycoBase 3+ database, a first-of-its-kind library of chromatographic retention positions expressed in glucose units for sets of glycan structures associated with a range of biotherapeutics.
Waters Corp., 800-252-4752, www.waters.com