Fusion QbD HPLC Method Development software is the Analytical Quality by Design toolset, extending the realm of Design of Experiments (DOE) beyond that of the statistician, to that of the chromatographer.
100% aligned with ICH Q8, Q9, Q10, and Q14 regulatory guidelines, Fusion QbD is the premier Analytical Quality by Design HPLC Method Development platform.
Fusion QbD is a true DOE package, with all predictions based on empirical models generated from multi-variate experimental raw data and never theoretical equations or proprietary algorithms. This means Fusion QbD can be applied to any separation mechanism, including mixed mode columns as well as:
- Ion Exchange
- Normal Phase
- Reverse Phase
- Size Exclusion/Gel Permeation
- Supercritical Fluid
Fusion QbD can also be applied to difficult sample matrix such as biologicals and other large molecules where classical baseline resolution is not achieved. This is due to Fusion’s ability to extract and model any peak property from your data system.
Integration with your chromatography data system (CDS) turns your HPLC into a rapid method development machine, with your defined experimental region translated directly into instrument methods and ready to run sequences.
Support for column and solvent switching valves enables rapid multi-column and multi-solvent screening for maximum instrument utilization and efficiency, while dynamic preparation of aqueous solutions (e.g. for pH screening) is available with quaternary pumps, saving analyst time and materials.
Fusion’s patented PeakTracker can use UV Spectra, Mass Spectra, and classical peak properties to track peaks and aid peak identifications, doing away with the need to identify peaks in your data system.
No MS? No Problem! Trend Responses may be used to holistically evaluate chromatograms and do away with the need to track peaks altogether during chemistry screening experiments where tracking peaks within the CDS can prove challenging.
Contact us for more information or to arrange a demonstration.
Fusion QbD is used by the US Federal Drug Administration (FDA) and United States Pharmacopeia (USP).
Using Fusion for LC method development is like putting on glasses you never knew you needed.
Since we started using Fusion QbD in our R&D lab, we spend much less time developing new analytical (LC) methods. Also, the methods are much more robust and reliable than before, since Fusion QbD provides the insight on knowledge space and design space, suggesting the most suitable parameters for the method.
Our use of Fusion QbD has moved from “Proof of Concept” to “Supporting Global Methods”. Our latest development was for a personal care beauty product, and the resulting method proved to be much more robust and simple to implement than the previous method. The product(s) impacted by this method represent hundreds of millions of USD in net sales, and we now have different manufacturing plants and innovation centres running the method around the world. The new method is 20% faster, but what is really imortant is that we have a method we know is never likely to give us problems, and we extract much more value from a trouble-free method.
Tepnel Pharma Services have invested in Fusion QbD software which in conjunction with Waters® Empower™ and H-Class UPLC Systems provides an integrated solution for robust method development and optimisation, reducing turnaround times from start to finish by ca 30-50% depending on the analytical complexity required.
- All the tools necessary for the successful adoption of Analytical Quality by Design as set out in ICH Q14
- Expert system with Automated mode ensures ease of use, with little to no statistical knowledge necessary
- Automated Design selection
- Validated data exchange with CDS builds all experimental methods and sequences automatically
- Support for automated column and solvent switching valves as well as on-line preparation of target pH or Buffer concentration levels
- Validated data Exchange for all results import, including Trend Responses, any peak property, and PDA/MS Spectra for automated Peak Tracking
- Automated Data Analysis to produce Response Surfaces, Effects Plots, Residual Analysis and Pareto Charts etc.
- Monti-Carlo Simulation used to produce Process Capability metrics for modelling of Robustness
- Best Answer Search used to apply mean performance and robustness goals for simultaneous optimization of both
- Graphical Tools for querying, reporting, and testing of Design Space/Method Operable Design Region
- Entire workflow within a closed loop 21 CFR Part11 compliant environment
- Produces robust and defensible methods
- Implements Quality by Design into your HPLC method development process
- Huge time savings
- Maximises instrument utilisation
- Eliminates transcription error
- Reduced risk of failure during validation and method transfer
- FDA 21 CFR Part11 compliant environment
The first step in Design of Experimentation is to define the Experimental Region. This consists of the parameters you wish to study and the ranges over which you which to study them.
Fusion QbD utilises a simple template containing the potential chromatographic study parameters.
Different templates exist for different chromatographic techniques and stage of HPLC method development. The templates support both column and solvent switching valves allowing for automated Column Solvent Screening studies to determine the best chemistry to take forward to optimization. This ensures maximum utilization of your HPLC while unattended.
Where a quaternary pump is used, Fusion QbD can automatically prepare different mobile phases. For example aqueous solutions of different pH or Buffer Strength. This reduces the time required to set up an experiment as the analyst only need prepare a stock solution(s) rather than multiple aqueous phases.
A Quality by Design approach requires that predictions are based on sound data. This is why we gather data from throughout your Experimental Region and utilise automation to generate real data sets from your HPLC overnight.
Fusion QbD uses a fully validated, GMP compliant, file-less data exchange to integrate with your chromatography data system. This integration allows the experimental design to be translated into a ready to run sequence(s) containing the experimental methods. These are ordered to maximise column stability and minimise equilibrium times. Performing the experiments and processing chromatograms remains the role of your data system.
Fusion QbD’s patented “Trend Response” removes the need to track peaks and in so doing the problems traditionally associated with peak tracking (co-elution and peak exchange). In effect it models co-elution, greatly reducing chromatogram processing time while improving the integrity of data sets.
Chromatogram results are automatically imported from completed sequences in a fully audited process. This ensures each data point is traceable to its source chromatogram within the data system.
Note. Any peak property may be imported and modelled. This is necessary when working with large molecules (e.g. peak height to valley ratios) or non-resolved samples (e.g. peak purity).
Automated data analysis provides a full suite of statistical reports that underpin the models’ adequacy. These include error analysis, residual tables and plots, and pareto ranking reports. Effective visualization of relationships between experimental parameters (critical process parameters) and results (critical quality attributes) is achieved via effects plots, contour plots and response surfaces. These promote knowledge and understanding.
The “Best Answer Search” feature, allows for the method performance goals to be entered and a search of the knowledge space initiated for the methods that meet or exceed these goals.
However, no HPLC Method Development software is complete without proper consideration of Robustness. Fusion QbD includes the patented Robustness Simulator which allows the calculation of Process Capability metrics (Cp, Cpk, Cpm, and Cpkm) using Monte Carlo Simulation.
This allows for optimisation of the HPLC Method for both mean performance and robustness goals simultaneously.
Graphical tools allow for the visualization and reporting of the multi-dimensional Design Space, within which a Control Space may be defined, verified and reported.
All associated experimental, statistical, and prediction reports are available for collation into a single report to support and defend decision making with sound experimental and statistical evidence. This may be electronically signed and/or exported to various file types as your needs require.
The image below is an example of a final Control Space definition set within the Robust Design Space. Moving the cursor within the design space renders a predictive chromatogram for those conditions.
All these tools exist in a fully audited, user access controlled, 21 CFR Part 11 compliant networked platform. This makes Fusion QbD the perfect HPLC method development software, fit for purpose in today’s method development laboratory.
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