Waters Corporation has reinforced its commitment to advancing biotherapeutic characterization technology at the Well Characterized Biotechnology Pharmaceuticals 2013 Symposium (WCBP 2013).
More specifically, Waters® has 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 innovations represent Waters’ continued focus on developing targeted solutions for developers of biotherapeutics and biosimilars, as well as related contract laboratory organizations.
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.
Waters Biopharmaceutical Platform Solution with UNIFI
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.
Today, 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 newly introduced released 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.
Developed by Professor Pauline Rudd's research team at Ireland's National Institute for Bioprocessing Research and Training (NIBRT), the GlycoBase 3+ Database is the first-of-its-kind repository of glycan chromatographic retention data, expressed in glucose calibration units, and encompassing the diverse sets of glycan structures associated with modern biotherapeutic glycoproteins.
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 Charged Surface Hybrid Particle Technology Columns
Waters’ new CSH130 particle technology columns offer unique selectivities for UPLC and HPLC peptide mapping and proteomics applications. The ACQUITY UPLC CSH130 C18 and XSelect™ HPLC CSH130 C18 Columns set a new standard in the analysis and purification of peptides for the quality of information generated by UPLC and UPLC/MS assays. The columns are available in a variety of particle sizes and column dimensions.
The novel columns feature Waters’ synthesis process for its Charged Surface Hybrid particles, which imparts a low level positive charge to the surface of each particle. This particle technology allows the columns to be used with a weaker acid modifier such as formic acid to obtain greater resolving power and improved method sensitivity compared to standard LC/MS methods that specify the use of MS signal-suppressing ion pairing additives such as trifluoroacetic acid (TFA).
The benefits of the Waters Biopharmaceutical Platform Solution with UNIFI for glycan analysis, as well as for biosimilar comparison and peptide mapping, are being presented in several posters being given at the WCBP 2013.
GlycoWorks Line of Consumable Products
Waters’ new GlycoWorks Line of Consumable Products brings together everything needed for the preparation of glycans for analysis, including sample preparation, labeling, clean-up and standards, along with methodologies and troubleshooting tools.
The product line includes two GlycoWorks prep kits, one for high throughput and another for single use, and a labeling kit. Each prep kit includes enzymatic deglycosylation with a variety of enzyme choices, HILIC sorbent for the cleanup and capture of released glycans, and a control standard to help with method validation, development and troubleshooting. A GlycoWorks 2-AB labeling kit includes four reaction reagents for use with released glycans.
Other consumable products from Waters that support glycan analysis include ACQUITY UPLC BEH Glycan columns that have been specifically developed and QC tested to provide superior UPLC component resolution for glycan structures; a Dextran calibration ladder that is 2-AB labeled for calibration; and a Glycan performance standard, a control standard of 2-AB labeled Human IgG.