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LC Method Development™ - Automated Method Development Software
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Works with all Waters® and Agilent LC Systems controlled by the Waters Empower™ (1 and 2) Chromatography Data Software
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Make Your LC a Rapid, Automated QbD Method Development System
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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.
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Phase 1 - Column and Solvent System Screening
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FMD brings a new approach to automated LC column and solvent system selection rooted solidly in QbD principles. Our 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 to place the column screening activity on a rigorous and quantitative footing. Most importantly, the Trend Responses approach eliminates the need for laborious and error-prone peak tracking in its column and solvent system screening experiments.
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Phase 2 - Robust Methdod Development and Optimization
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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 our patented Robustness Simulator™ technology (U.S. Patent No. 7,606,685 B2), which integrates automatically computed robustness metrics for all critical quality attributes studied into its method development experiments. The new methodology thus automates a best-practices approach in which HPLC methods can be rapidly developed and simultaneously optimized for mean chromatographic performance and method robustness.
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Pharma Customer Benchmarking
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Recent work conducted at a large pharmaceutical company to benchmark the effectiveness of FMD used in combination with Empower 2 and ACQUITY UPLC demonstrated that it was possible to reduce method development time for a complex drug product from 45-60 days to two days when compared to the conventional one-factor-at-a-time development approach.
In addition, many of our customers have told us 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!
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Application Notes
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Fusion AE has been in use for several years now. Our customers have successfully used Fusion AE to develop and optimize LC methods according to QbD guidelines for a wide variety of sample types, including small molecules, peptides, proteins, and nucleotides. Fusion AE supports a wide range of chromatographic techniques for these samples, including reversed phase, normal phase, ion exchange, and HILIC, and it has never failed to identify an improved method which meets performance requirements.
Below is the first of many application notes we will be posting here in the coming months which demonstrate the power and efficiency of Fusion AE for chromatographic methods development.
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Download
(PDF, 207 KB)
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Application Note 001-09
Rapid development of an LC method for separating high molecular weight degradants from a biopharmaceutical product using an automated Design of Experiments (DOE) approach.
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(PDF, 723 KB)
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Application Note 002-09
Using a Design of Experiments Approach to Develop Fast LC Methods for Automated Scale-up to Preparative Chromatography of Sulfa Drugs |
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White Papers
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Download
(PDF, 857 KB)
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Part 1 of 3
A Quality-by-Design Methodology for Rapid HPLC Column and Solvent Selection
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Download
(PDF, 1.03 MB)
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Part 2 of 3
A Quality-by-Design Approach to Rapid Development of Robust HPLC Methods
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Download
(PDF, 962 KB)
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Part 3 of 3
Automating HPLC Analytical Method Development
Fusion AE™ Software Program White Paper
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