New Biopharmaceutical Information System Unites UPLC/MS Analyses and Workflows

The new Waters® Biopharmaceutical System Solution brings together UPLC®/MS characterization technology with UNIFI™ Scientific Information System. This industry first comprehensive software solution uniquely unites all aspects of biotherapeutic analyses and workflows for high-resolution analytics across the development process continuum.

The combination of UltraPerformance Liquid Chromatography®, mass spectrometry, and bioinformatics technologies results in efficient flow of data and information and conforms to biopharmaceutical quality guidelines and regulations.

The Biopharmaceutical System Solution includes:
• ACQUITY UPLC® 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 and Protein Separation Technology Columns engineered with the selectivity to leverage the characteristics of biomolecules and QC-tested to ensure consistent results;
• Xevo® G2 Tof Mass Spectrometer, the most sensitive exact-mass quantitative and qualitative benchtop MS 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.

“Waters is now the first company to offer biopharmaceutical scientists a total system for protein characterization using high-end mass spectrometry that supports good manufacturing practices regulations (GMP) that biopharmaceutical companies are required to comply with,” said Jeff Mazzeo, Director of Biopharmaceutical Business Operations for Waters Division. “In addition to being able to operate in a GxP compliant environment, the new Biopharmaceutical System allows customers to extract and share the maximum amount of information. For example, when a scientist develops a peptide map in the discovery laboratory, all of the methods and reports generated can be shared with colleagues down the line in the quality control (QC) laboratory leading to significant productivity gains. UNIFI is the common platform that allows customers to share information in a much more efficient manner than previously possible.”

Focused on task-specific workflow design, the Biopharmaceutical System features automated data processing and simplified results validation. Leveraging UNIFI’s architecture, the intuitive user interface can be configured for the roles and capabilities of the scientists throughout an organization. Critical to biopharmaceutical organizations is reliance on an analytical system that supports GMP and compliance tools, such as electronic signatures and user authentication, all with underlying secure database technology. Lastly, this Biopharmaceutical System is scalable to use as a workstation with the ability to expand to workgroup and enterprise deployments.