Waters Adds Fusion Method Development Software from S-Matrix to Automate LC Method Development

Waters Corporation has become the exclusive distributor of Fusion Method Development™ 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.

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 work1, 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 by following the Company article page link top right of this page.