News Releases

<< Back
Waters Adds Fusion Method Development Software from S-Matrix to Automate LC Method Development According to Quality-by-Design Guidelines
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 (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 (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 (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 (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.

SOURCE Waters Corporation

Brian J. Murphy, Public Relations Manager, Waters Corporation, +1-508-482-2614, brian_j_murphy@waters.com