Waters biopharmaceutical system unites
UPLC/MS analyses and workflows
31 Jan 2011
Waters Corporation has introduced its Waters
Biopharmaceutical System. This brings together UPLC/MS
characterization technology with UNIFI scientific information
system, a comprehensive software solution that
uniquely unites all aspects of biotherapeutic analyses and workflows
for high-resolution analytics.
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 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
- 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;
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.
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
With the scalability and flexibility built into the system,
customers can anticipate the following benefits from the
- 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
- 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; and
- Because customers ultimately know best how to meet
their regulatory compliance requirements; the Biopharmaceutical
System provides a configurable tool to enable customers to deploy
analytical technologies with the greatest efficiency.