Waters has introduced its Waters biopharmaceutical system solution, bringing together UPLC/MS characterisation technology with the Unifi scientific information system.
The system was unveiled at WCBP, the 15th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products in Washington, DC.
The software solution unites all aspects of biotherapeutic analyses and workflows for high-resolution analytics across the development process continuum.
Waters said the combination of ultra-performance 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 Autoblend Plus technology, for flexibility in executing high-resolution bio-separations; and Waters peptide and protein separation technology columns engineered with the selectivity to leverage the characteristics of biomolecules and QC-tested to ensure consistent results.
It also incorporates: Xevo G2 Tof mass spectrometer, a sensitive exact-mass quantitative and qualitative bench-top MS system designed with engineered simplicity; and Unifi scientific information system, an interactive workflow-driven data platform for flexible instrument control, advanced data processing and mining and reporting, with GxP laboratory compatibility that enables routine deployment throughout the organisation.
Jeff Mazzeo, director of pharmaceutical business operations for Waters, said: '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,' he added.
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 organisation.
Critical to biopharmaceutical organisations 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.
This biopharmaceutical system is scalable to use as a workstation with the ability to expand to workgroup and enterprise deployments.
The system is scalable and flexible and, according to Waters, will offer many benefits for customers.
These include: implementing proven UPLC, exact-mass Tof MS, and bioinformatics technologies purposely built for biotherapeutic analysis, the system addresses protein characterisation needs today and laboratories' growth plans for the future; streamlining analytics by standardising workflows across laboratories, and expedite development decisions and regulatory filings with efficient information synthesis is designed to increase productivity.
With the versatility to meet the needs of multiple users in a diverse analytical organisation, the Unifi-based platform is said to enable easier transfer of information between departments, so therapeutics can efficiently move from non- regulated investigations to compliant analyses.
The biopharmaceutical system provides a configurable tool to enable customers to deploy analytical technologies with efficiency.
