Waters Corporation today introduced its Waters Biopharmaceutical System Solution at WCBP, the 15th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products in Washington, DC, USA.
The new system brings together UPLC/MS characterization technology with UNIFI™Scientific Information System, an industry first comprehensive software solution that 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.
With the scalability and flexibility built into the system, customers can anticipate the following benefits from the biopharmaceutical system:
* Implementing proven UPLC, exact-mass Tof MS, and bioinformatics technologies purposely built for biotherapeutic analysis, the system
addresses protein characterization needs today and laboratories’ growth plans for the future.
* Streamlining analytics by standardizing 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 organization, the UNIFI-based platform enables easier transfer of information between departments, so therapeutics can efficiently move from non-regulated investigations to compliant analyses.
* Because customers ultimately know best how to meet their regulatory compliance requirements; the system provides a configurable tool to enable customers to deploy analytical technologies with the greatest efficiency.