Fusion Method Development Software

Fusion QbD Supports Full Compliance and Data Integrity in Perfect Alignment with all Regulatory APLM and AQbD Guidances

The only software platform that is 100% aligned with the Analytical Procedure Lifecycle Management (APLM) model and supports full closed-system regulatory compliance, including bi-directional auditing with the CDS, to meet regulatory expectations of required data integrity.

Fusion QbD Perfectly Integrates DOE, Chromatography Modeling, and Experiment Automation

The only software platform with a complete and perfect integration of Design of Experiments methodology (DOE), Chromatography Modeling, and Experiment Automation on Agilent, Thermo, and Waters LC systems for fully automated walkaway experimenting.

Fusion QbD Supports all Phases of LC Method Development

The only software platform that supports all phases of your LC method development work, including Sample Preparation, Initial Sample Workup, Chemistry System Screening (also called Method Scouting), and Robust Method Optimization using in-silico Monte Carlo robustness modeling of all critical method performance characteristics to establish the Method Operable Design Region (MODR) — the analytical method’s robust design space.

Fusion QbD Fully supports all Chromatographic Separation Modes for Both Small and Large Molecules

The only software platform that supports all separation modes for both small and large molecules, including RPC, NPC, IEX, SEC, HILIC, HIC, Chiral, and SFC. Fusion QbD is used successfully for Peptide Mapping, mAbs, and also for development of Non-LC methods such as CE, GC, and Dissolution.

Fusion QbD Includes Fully Automated UV and MS Spectra Based Peak Tracking

The only software platform that supports fully automated peak tracking using traditional peak data, UV spectra data, and MS spectra data from the Waters QDa, SQD, and SQD2 Mass Detectors – support for other MS systems will be coming in 2021.

Turn Your LC System into a Method Development Powerhouse

Click here to see a history of Fusion QbD automation. Click here to see a list of currently supported Chromatography Data Software, and HPLC, UHPLC, and SFC systems!

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

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.

Fusion QbD revolutionizes method optimization with the integration of (1) flexible DOE Experimental Design, (2) automated UV and MS Based Peak Tracking, (3) retention-based Resolution Map Modeling, along with modeling all individual peak resolutions and all other required method chromatographic performance requirements (e.g. Area, Tailing, K-prime, Plates, etc.), (4) modeling all study parameter effects on all critical performance characteristics, including linear, non-linear, and Interaction Effects, and (5) the correct and regulatory accepted Integration of QbD Robustness.

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!

S-Matrix has now created a new Forced Degradation Study mode to support experiments in which the different Sample Preparation replicates represent different degradation paths such as photo degradation, acid degradation, and peroxide degradation. This activates an entirely new technology which aggregates peak data from the replicates for each run into a “Composite Chromatogram” data set for the run to be used in robust method optimization and prediction chromatogram visualization.

PeakTracker™ automates, optimizes, and simplifies the use of PDA and MS data in chromatographic method development. PeakTracker uses 3D PDA spectra data augmented with standard UV peak results data to automatically identify each peak in each experiment chromatogram. PeakTracker also fully utilizes 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: