Fusion QbD®

Fusion Method Development

Chromatography-centric QbD Software for LC, LC-MS, and SFC Method Development

Links to More Information about Fusion Method Development!

Product Brochure (PDF | Online) • Part 11 CompliancePresentations/ArticlesApplication Notes

NEW: Mapping Key Elements in ICH Q14 and USP <1220> to an
Enhanced Workflow for Analytical Procedure Development

NEW VIDEO: LC Method Development for Large Molecules Using Fusion QbD

APLM Stages

Analytical QbD

Chromatography-centric QbD Software for the Development, Validation, and Transfer of Analytical Methods

  • LC, LC-MS, SFC
  • Sample Preparation
  • GC, CE, Dissolution, and More...

Follow the Analytical Procedure Lifecycle
Management Workflow with Fusion QbD!

Rapid Chemistry System Screening

Rapid Chemistry System Screening

A Rigorous Quantitative Approach to Stationary and Mobile Phase Chemistry Selection (Method Scouting)

Patented Trend Responses automatically extract critical information on shape and selectivity from each experiment chromatogram without the need for peak tracking at the screening stage.

Quickly Identify Critical Method Parameters and
Select Study Ranges for Follow on Optimization Experiments

Robust Method Optimization (LC, LC-MS, SFC, …)

Robust Method Optimization

Revolutionary Method Optimization with:

  • Flexible DOE Experimental Design
  • Automated UV & MS Based Peak Tracking
  • Retention-based Resolution Modeling
  • Monte-Carlo Robustness Simulation
  • Forced Degradation Study Automation
  • Non-LC Method Development (GC, CE, Dissolution)

Establish the Robust Method Operable Design Region (MODR)
for All Critical Analytical Method Attributes

Sample Preparation Method Optimization

Sample Preparation

Rapid Screening to Identify All Critical Method Parameters

Full CDS Automation for LC Testing

Robust Optimization with Monte-Carlo Robustness Simulation

Establish the Robust Method Operable Design Region (MODR)
for All Critical Sample Preparation Method Attributes

Interval Test

Replication Strategy Optimization

The Number of Individual Measurements Described in the Analytical Procedure Which Contribute to the Calculation of the Reportable Result

  • Characterize the Total Analytical Error (TAE)
  • Quantify the Percent Contribution of Sample Preparation and Sample Injection to the TAE
  • Combine Accuracy (Bias) and Precision Using
    USP <1210> Interval Metrics

Identify the Optimum Replication Strategy for
All Critical Analytical Method Performance Requirements

Analytical Method Validation

  • Analytical Capability
  • Specificity
  • Filter Validation
  • Sample Solution Stability
  • Accuracy / Linearity / Repeatability
  • LOQ, LOD
  • Robustness
  • Intermediate Precision
    & Reproducibility

Comprehensive Method Validation Experiment Suite Meets All FDA, ICH, and USP Requirements and Guidances, Including ICH Q2, USP <1210>, USP <1220>

  • Small Molecule – Traditional Pharmaceutical Substances and Products
  • Large Molecule – the Only Complete and Automated Method Validation Software for Biopharmaceutical Products (e.g., MAbs)
  • Non-LC Methods – Also Used for a Wide Variety of Analytical Methods (e.g., CE, GC, QNMR, …)

Full CDS Automation / Full Regulatory Compliance / Maximum Efficiency

Analytical Method Transfer

Analytical Method Transfer

Method Transfer Studies Across Multiple Labs / Sites with Full CDS Automation

Stage 3 – Ongoing Method Performance Verification

Interval Test

Knowledge Gained with Fusion QbD in APLM Stages 1 and 2 Feeds Directly into Stage 3

Use CDS software, SPC/SQC software, or even MS Excel to monitor analytical performance and confirm that performance meets ATP criteria on an ongoing basis.

APLM Stages 1 and 2

S-Matrix – Software Solution Partner of:

Agilent Technologies logo Thermo Fisher Scientific logo Waters logo

Adobe PDF

Protein and Peptide Application Examples


Adobe PDF

Sample Preparation Example


Adobe PDF

Dissolution Example


Adobe PDF

CE Method Development Example


S-Matrix is the World Leader in QbD Experimentation Software for the development, validation, and transfer of LC, LC-MS, and SFC methods.

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 2022.

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!

Rapid Chemistry Screening – Column, pH, Gradient, Mobile Phase

Fusion QbD® brings a completely new quantitative approach to automated LC column and solvent system selection that is completely aligned with QbD principles and methodology. S-Matrix's patented Trend Responses™ technology overcomes the limitations inherent in traditional approaches, and replaces a qualitative “pick-the-winner” approach with a rigorous and quantitative methodology. Most importantly, Trend Responses eliminate the requirement for laborious and error-prone peak tracking in column and solvent system screening experiments. Click here to see examples of the amazing results achieved in JUST A FEW DAYS with this approach!

Fast Chemistry System Screening
Simple Chromatogram Processing in Empower
Robust Method Optimization

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.

Optimization with Forced Degradation Study Automation
Forced Degradation Study Automation

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.

Automated UV and MS Based Peak Tracking

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:

Automated UV and MS Based Peak Tracking
LC Method Development for Large Molecules aligned with ICH and USP Guidances

This video presentation will illustrate using the standard method development workflow in Fusion QbD for development of Large Molecule LC methods The presentation will use a recently completed project which successfully developed a CIEX Method for mAb Charge Variant Analysis to illustrate the standard method development workflow in Fusion QbD:

LC Method Development for Large Molecules

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