Fusion LC Method Development™
Analytical Grade QbD Software
Works with:
- Waters® and Agilent LC Systems controlled by the Waters Empower™ 2 and 3 Chromatography Data Software (CDS)
- Agilent LC Systems controlled by the Agilent ChemStation and OpenLab CDS
- Thermo Scientific Dionex® Chromeleon® 6.8 and 7.2
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 Waters or Agilent 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
- Quality by Design (QbD) Principles and Guidelines – Built In!
- Formal Experimental Design
- Experimental Interaction Effects Characterization
- Integrated Monte Carlo Simulation for Robustness
- 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
- QbD Design and Operating Space Visualization – Built In!
- Best Answer Search
- Formal Design Space
- Proven Acceptable Ranges
- 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.
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
