For biopharmaceutical organizations challenged to deploy high-resolution analytics across the innovative biotherapeutic or biosimilar development process, Waters has designed the ultimate system for your lab's future.

The Waters Biopharmaceutical Platform Solution with UNIFI integrates robust UPLC/MS characterization technology with comprehensive software, for applications in bioseparations, intact protein mass analysis, peptide mapping, and released glycan analysis.

The platform enables a biopharmaceutical laboratory to comprehensively and routinely acquire, process, and share LC and MS characterization data throughout a biotherapeutic’s lifecycle. It unites all aspects of biotherapeutic analyses and workflows, and enables results to be can readily be shared from discovery to development to GxP quality control laboratories.

Whether you undertake advanced investigative work or execute routine methods, the Biopharmaceutical Platform Solution increases confidence in your results – confidence that you have obtained the best results for development decisions, and confidence that you have acquired the information necessary to address to regulatory requirements.

At the heart of this unique platform is our new UNIFI Scientific Information System:
■ UNIFI is the first software to merge LC and MS data in a single solution that encompasses bioinformatics data processing, visualization, reporting, and configurable compliance tools
■ The system 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
■ UNIFI's data mining and comparison capabilities enhance your ability to understand results with an unparalleled ability to aggregate and manage information

The Waters Biopharmaceutical Platform includes:
■ ACQUITY UPLC H-Class or 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; also available with ACQUITY UPLC H-Class
■ Waters Protein, Peptide, or Glycan Separation Technology Columns, engineered with the selectivity to leverage the characteristics of biomolecules and QC-tested to ensure consistent results over the lifetime of your product
■ Xevo G2 Tof and Xevo G2-S QTof Mass Spectrometers, for the most sensitive exact-mass quantitative and qualitative MS, in a benchtop system designed with Engineered Simplicity
■ UNIFI Scientific Information System, an interactive workflow-driven data platform for flexible instrument control, advanced data processing and mining, and comprehensive reporting, with GxP laboratory compatibility that enables routine deployment throughout your organization
■ GlycoBase 3+ database, a first-of-its-kind library developed in collabration with NIBRT of chromatographic retention positions expressed in glucose units for sets of glycan structures associated with a range of biotherapeutics.
■ Waters Analytical Standards and Reagents for biopharmaceutical analysis, enabling SEC and released glycan separation calibration, and system check standards for intact mass, peptide map, and released glycan workflows