Biopharmaceutical Platform Solution with UNIFI

The platform enables a biopharmaceutical laboratory to comprehensively and routinely acquire, process, and report LC and MS characterization data throughout a biotherapeutic’s development lifecycle. From bioseparations to LC/MS characterization, the Waters Biopharmaceutical Platform Solution with UNIFI Software provides detailed workflows that enable results to be readily be shared from discovery to development to GxP quality control laboratories.

Whether you undertake advanced investigative work or execute routine methods, our platform will increase your confidence in results – confidence that you have obtained the best results for development decisions, and confidence that you have 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 data processing, visualization, reporting, and configurable compliance tools
• GlycoBase Database of glucose unit (GU) values is now integrated as a library within UNIFI, to streamline the analysis of glycoproteins, including the identification of glycan retention times and correlated glycan structures.
• Supports a mix of quadrupole time-of-flight (Q-Tof) MS and optical detection instruments within a laboratory network
• 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-XS QTof Mass Spectrometer, 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

All of your challenges can be met through the extensive capabilities of the Biopharmaceutical Platform Solution with UNIFI – whether your lab is new or growing. If you are looking to support your biotherapeutic with routine and robust characterization technology that is managed by the same user interface, methods, and information that will transfer from discovery to development to quality control, this is the system that will grow with you.

Key features:

• Automate the routine processing of your data and simplify the validation of your results
• Work within an intuitive interface that can be configured for the roles and capabilities of the scientists throughout your organization
• Rely on industry-standard GxP compliance tools, from electronic signatures, to complete audit trails, to user authentication, with the underlying security of a relational database architecture
• Use as a workstation with the ability to expand to workgroup and enterprise deployments
• UNIFI and UPLC bioseparations with optical detection provide the foundation to easily add MS at a later date
• Leverage MS to obtain exact mass precursor and fragment ion information from every detectable component with Waters’ patented MS^E technology to fully annotate your peptide map

Key benefits:

• Implement proven UPLC, exact-mass Tof and Q-Tof MS, and bioinformatics technologies, purpose-built for biotherapeutic analysis, that will address your characterization needs today – and your laboratory’s growth plans for the future
• Streamline analytics by standardizing workflows across laboratories, and expedite development decisions and regulatory filings with efficient information synthesis
• With the versatility to meet the needs of multiple users in a diverse analytical organization, the UNIFI-based system solution enables easier transfer of information between departments, so your therapeutic can efficiently move from non-regulated investigations to GxP-compliant analyses
• Your organization knows best how to meet your regulatory compliance requirements; Waters provides you with configurable tools to enable your company to deploy analytical technologies with the greatest efficiency

Dive deeper into your data, when necessary, to confirm unexpected results.

Investigate tab in UNIFI.

Learn about the engine of the Biopharmaceutical System Solution: the UNIFI Scientific Information System.

Quickly navigate through processed results to obtain the information you desire about your biomolecule.

Reviewing results from a routine method in UNIFI.