DOE-based software with a complete library of design types

Fusion LC Method Development™

Analytical Grade QbD Software

Works with the following Chromatography Data Software:

Turn Your LC into an Automated QbD Method Development System

Fusion LC Method Development™ (FMD) controls most internal and external column switching valves and solvent selection valves for your Agilent, Thermo, or Waters LC system. This enables you to do rapid method development for all types of LC chromatography, including Reversed Phase, Normal Phase, Chiral, HILIC, Ion Exchange, and Size Exclusion. You can use FMDs standard screening and optimization experiment templates or create your own. You can even use FMD to automate your own exploratory (non-DOE) studies and protocols.

Key Benefits
  1. Quality by Design (QbD) Principles and Guidelines – Built In!
    • Formal Experimental Design
    • Experimental Interaction Effects Characterization
    • Integrated Monte Carlo Simulation for Robustness
  2. Automated QbD-aligned Experimentation – Built In!
    • Experimental Design Wizard
    • Experiment Automation Wizards
    • Export Wizard builds your experimental design in the CDS
    • Import Wizard automatically imports all chromatogram results data from the CDS
    • Data Analysis & Modeling Wizard
  3. QbD Design and Operating Space Visualization – Built In!
    • Best Answer Search
    • Formal Design Space
    • Proven Acceptable Ranges
  4. 21 CFR Part 11 Compliance Support Toolset – Built In!
    • Automated and audited data exchanges with the CDS
    • E-record and E-signature controls with full work auditing
    • Workflow Management System with E-review and E-approve Capabilities
Rapid Chemistry Screening – Column, pH, Mobile Phase Composition

FMD brings a new approach to automated LC column and solvent system selection that is completely aligned with the principles of QbD. S-Matrix's patented Trend Responses™ technology (U.S. Patent No. 7,613,574 B2) overcomes the limitations inherent in both the sequential and classical Design of Experiments (DOE) approaches and places column and solvent screening method development activities on a rigorous and quantitative footing. Most importantly, the Trend Responses approach eliminates the requirement for laborious and error-prone peak tracking in phase 1 column and solvent system screening experiments.

Robust Method Development and Optimization

FMD brings a new QbD-based methodology to formal HPLC method development. Regulatory guidances state that the best-practices approach should address robustness during formal method development. Therefore, a critical feature of FMD is the patented Robustness Simulator™ technology (U.S. Patent No. 7,606,685 B2), which integrates automatically-computed method robustness metrics for all Critical Quality Attributes (CQA) studied, into method development experiments. This novel methodology automates a best-practices approach in which LC methods can be rapidly developed and simultaneously optimized for mean chromatographic performance and robustness.

NEW!

Automated Peak Tracking

PeakTracker™ automates and simplifies the use of PDA and MS spectra data in LC and LC/MS method development. PeakTracker uses 3D PDA spectral data augmented with standard UV peak results data to automatically identify each peak in each experiment chromatogram. PeakTracker will also fully utilize 3D mass spectral data for experiments run on LC systems configured with the Waters Acquity QDa Mass Detector (QDa). Complex separation and tracking challenges PeakTracker can automatically address include:

TRACK NON-IONIZING PEAKS

TRACK NON-ABSORBING PEAKS

NEW!

Rs-Map and Multi-Response Overlay Graph Modes with Prediction Chromatograms for the Entire Design Space

Rs-Map Response new modeling and graphing mode companion to the Multi-Response Overlay mode — both with simulation chromatogram visualization and reporting capabilities. You can quickly toggle between modes and move your mouse pointer around the graphs and see the predicted results data and simulation chromatograms update in real time. You can also instantly generate reports which include prediction results, graphs, and simulation chromatograms in your final reports.

RS-MAP RESPONSE MODE

MULTI-RESPONSE OVERLAY MODE

NEW!

Predicted Response Data

When you predict method performance for experiment runs, you can see the actual experiment run chromatogram together with the simulation chromatogram for immediate numerical and visual comparisons. You can also zoom and format the chromatogram displays, stack and offset multiple chromatograms, and include the custom views in your reports.

NEW!

Buffer Selector for Online pH Preparation

Fusion QbD now has a new “Buffer Selector” with pre-defined buffer curves and data. Clicking the “Buffer Selector…” button in the Experiment Setup window (1st image below) launches the Buffer Selector (2nd image below). Selecting the desired buffer system and checking the desired target pH levels to include in the experiment auto-populates the pH Variable settings in Experiment Setup (as shown in the images below). Fusion QbD will automatically build the mobile phase ratio required for a given target pH level into the associated LC Instrument Method it constructs for the experiment run.

Pharma Customer Benchmarking

Recent work conducted at a large pharmaceutical company to benchmark the effectiveness of FMD demonstrated that it was possible to reduce method development time for a complex drug product from 45–60 days to JUST TWO DAYS when compared to the conventional one-factor-at-a-time (OFAT) development approach. In another typical example, a Biopharma customer has consistently reduced LC and CE method development time for their MAb products from several months to under two weeks!

In addition, many customers using Fusion have confirmed that FMD has enabled them to identify truly optimized, robust methods which they never would have been able to discover using their conventional approaches and software!

"Using Fusion for LC method development is like putting on glasses you never knew you needed"

—DAN PRUDHOMME, RESEARCH SCIENTIST, GILEAD SCIENCES, FOSTER CITY, CA

"After a single set of overnight HPLC runs, Fusion identified the appropriate column and conditions necessary for separating a multi-component mixture containing a pharmaceutical product from three known synthetic intermediates, four known related impurities and revealed four new related impurity peaks, something a contract method development laboratory had been unable to do over several months and at great cost".

—DR. TIM ECKERSLEY, CAMBRIDGE ISOTOPE LABORATORIES, ANDOVER, MA