Automated, Quality-by-Design solution for rapid LC method development

Fusion Method Development™ Software from S-Matrix integrates seamlessly with Water's ACQUITY UPLC® and Empower™ 3 Chromatography Software to automate LC method development, according to Quality by Design (QbD) guidelines recommended by the U.S. FDA and the International Conference on Harmonisation (ICH).

Fusion Method Development Software transparently manages complex statistics, models method screening, and optimization experiments, and integrates method robustness testing during method development.

Fast and reliable development of robust methods

With adopting QbD and building quality into the product and process, the challenge of moving through the development process efficiently, without compromising data quality or increasing costs, has never been greater. Fusion Method Development's unique capabilities address this challenge, helping you meet or exceed laboratory and organizational goals:

• Reduce LC method development time from weeks or months to days.
• Employ statistically rigorous, Design of Experiment (DOE) based experiments that are automatically re-constructed as ready to run methods in Empower 3
• Employ rigorous statistics and models for method development and maintain compliance with Empower 3.
• Easily interpret results with multiple visualization options.
• Save time and reduce solvent usage with efficient experimental protocols using ACQUITY UPLC.
• Scale from a single workstation to full network or Citrix environment.

Visualize method performance and robustness with Fusion Method Development's overlay graphics.  The color-coded response maps define the QbD Knowledge, Design and Operating Spaces. With these spaces defined, users can automatically predict robust LC methods.

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Quickly design and run automated experiments

Fusion Method Development automatically builds and runs experiments that screen multiple columns and mobile phases and optimizes LC methods using standard or user-customized templates. Incorporating a systematic Quality-by-Design approach, Fusion Method Development automatically selects the most efficient statistical design that defines the QbD knowledge space. 

With one click, Fusion Method Development transfers the experimental design to Empower 3 as ready-to-run methods and sample sets.

Implement an efficient two-phase method development strategy

To quickly develop optimized LC methods, Fusion Method development uses a two-phase strategy:

• Phase 1 - Column and Solvent Screening
  Rapid screening experiments study the major effectors of LC method performance, including column type, pH, and mobile phase composition. Fusion automates the control of internal and external column and solvent switching valves to enable walk-away experimentation
• Phase 2 - Method Optimization
  

  Phase 2 experiments use the results from Phase 1 plus additional variables with tighter ranges to determine the optimum LC method. Fusion also applies a unique combination of Monte Carlo Simulation and Process Capability statistics to quantitatively evaluate method robustness.

Analyze data without tracking peaks

Fusion Method Development's patented Trend Response™ operators automatically characterize the quality of chromatographic separations and eliminate the need for laborious and often inaccurate peak tracking during initial rapid screening experiments.

Fusion Method Development analyzes and models critical method performance characteristics easily. Response surface plots show the combined effects of variables on key chromatographic responses such as peak resolution, tailing, and retention. Color gradation represents the magnitude of interactions with curvature indicating the type of interaction.

Response surface plots show the combined effects of variables on key chromatographic responses.

Automatically predict mean method performance and robustness

Chromatographic data are used to generate parameter-effect models which are displayed numerically using the Automated Optimizer and graphically as Overlay graphs for easy interpretation.

User-defined method performance goals are quickly tested with the Automated Optimizer wizard that searches for the LC method that meets all performance goals simultaneously and displays these as method predictions.

Fusion Method Development overlay graphs predict mean method performance and robustness. These graphs show method variable ranges that define the QbD knowledge and design spaces. Non-shaded areas correspond to variable ranges that exceed all goals for mean method performance.

The Robustness Simulator™ incorporates robustness testing into LC method development. This patented simulator computes and models the impact of key chromatographic parameters on method robustness. Using the Robustness simulator identifies methods optimized for both mean performance and robustness without the need for additional experiments.