Waters Corporation has become the exclusive distributor of Fusion Method Development software, from S-Matrix Corporation.
The software works with Waters Empower 2 chromatography data software (CDS) and Acquity ultra-performance LC (UPLC) to automate liquid chromatographic method development according to Quality-by-Design (QbD) guidelines.
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 that establish the final design and operating spaces for optimised 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, 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 '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).
Utilising an 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 optimised 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 and beverage, fine chemicals and environmental labs.