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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.