Waters Adds Fusion Method Development Software from S-Matrix to Automate LC Method Development According to Quality-by-Design Gu
14 Diciembre 2009 - 9:00AM
PR Newswire (US)
Fusion Method Development software Produces More Robust Methods
Faster; Method Development Time Reduced from 45-60 Days to 2-3 Days
MILFORD, Mass., Dec. 14 /PRNewswire-FirstCall/ -- Waters
Corporation (NYSE:WAT) has become the exclusive distributor of
Fusion Method Development(TM) software, developed by S-Matrix®
Corporation. The software works seamlessly with Waters® Empower® 2
chromatography data software (CDS) and ACQUITY UltraPerformance LC®
(UPLC®) to automate liquid chromatographic method development
according to Quality-by-Design (QbD) guidelines. Fusion not only
greatly accelerates method development, it enables development of
more robust methods which transfer successfully and withstand the
test of repeated use. Using a QbD-based methodology for LC method
development allows scientists to develop the best possible method
much faster and with much greater confidence. Fusion works with
Empower 2 and ACQUITY® UPLC to increase lab efficiency by designing
statistically valid experiments and automatically reconstructing
them in Empower 2 as fully ready-to-run sequences. Fusion uses the
resulting data to generate parameter-effects models which establish
the final design and operating spaces for truly optimized LC
methods. This automated process ensures that scientists develop the
right method the first time and translate chromatographic data into
information, knowledge and answers. Recent work(1), conducted at a
large pharmaceutical company, to benchmark the effectiveness of
Fusion Method Development used in combination with Empower 2 and
ACQUITY UPLC, demonstrated that it was possible to reduce method
development time for a complex drug product from 45-60 days to two
days when compared to the conventional one-factor-at-a-time
development approach. Fusion Method Development also addresses
regulatory recommendations to incorporate robustness into LC method
development (ICH Q2B Validation of Analytical Procedures -
Methodology). Utilizing a patented approach built on sound
statistical process control techniques, the software computes and
models the impact of key chromatographic parameters on method
robustness. This enables identification of methods optimized for
both mean performance and robustness without the need for any
additional experiments. Establishing the final design space for a
method in this manner creates the basis for regulatory flexibility
and continuous improvement (ICH Q8(R1) Pharmaceutical Development).
Use of Fusion Method Development software crosses virtually all
laboratories served by LC, including pharmaceutical, food &
beverage, fine chemicals, and environmental labs. More information
on Fusion in combination with Empower 2 and ACQUITY UPLC is
available on Waters web site at
http://www.waters.com/waters/nav.htm?cid=10137325. 1. A
Quality-by-Design Methodology for Rapid LC Method Development, Part
III. Ira Krull, Michael Swartz, Joseph Turpin, Patrick H. Lukulay,
Richard Verseput. LCGC North America, April 1 2009 About Waters
Empower 2 CDS (http://www.waters.com/empower) Empower 2 Software,
Waters flagship CDS, makes it easy to run samples and produce
meaningful results. Empower 2's interface is designed to maximize
productivity, improving collection, processing and printing
chromatographic data, with capabilities that include customizable
data reports, integrated custom calculations, advanced data
management, and intuitive online answer wizard. Known for its 21
CFR Part 11 compliance-readiness, advanced data integrity, audit
trails and security features, Empower 2 is the industry's gold
standard CDS. About ACQUITY UPLC (http://www.waters.com/uplc) The
ACQUITY UPLC System eliminates significant time and cost per sample
from analytical processes while improving the quality of results.
By outperforming traditional or optimized HPLC, the system allows
chromatographers to work at higher efficiencies with a much wider
range of linear velocities, flow rates, and backpressures. UPLC
Technology, which has been adopted successfully in laboratories
around the world for the most demanding separations, is a highly
robust, dependable, and reproducible system. What differentiates
the system's holistic design is Waters' patented sub-2 micron
hybrid particle chemistry, significant benefits over today's HPLC
systems equipped with standard 5 micron particle chemistries. About
S-Matrix (http://www.smatrix.com/) S-Matrix Corporation develops
advanced Design-of-Experiments (DOE) based software that automates
R&D experimental work according to accepted Quality-by-Design
principles and methodologies. Strategic business alliances with key
industry and academic customers, analytical instrument, and process
equipment companies enable S-Matrix to rapidly bring to market
innovative Automated Experimentation techniques and software for
targeted industry applications. About Waters Corporation
(http://www.waters.com/) For 50 years, Waters Corporation
(NYSE:WAT) has created business advantages for laboratory-dependent
organizations by delivering practical and sustainable innovation to
enable significant advancements in such areas as healthcare
delivery, environmental management, food safety, and water quality
worldwide. Pioneering a connected portfolio of separations science,
laboratory information management, mass spectrometry and thermal
analysis, Waters technology breakthroughs and laboratory solutions
provide an enduring platform for customer success. With revenue of
$1.58 billion in 2008 and 5,000 employees, Waters is driving
scientific discovery and operational excellence for customers
worldwide. Waters, ACQUITY UPLC, UltraPerformance LC, UPLC, and
Empower are trademarks of Waters Corporation. S-Matrix and Fusion
Method Development are trademarks of S-Matrix Corporation.
DATASOURCE: Waters Corporation CONTACT: Brian J. Murphy, Public
Relations Manager, Waters Corporation, +1-508-482-2614, Web Site:
http://www.waters.com/
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