FusionChrom? - PowerPoint PPT Presentation

Title: FusionChrom?


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FusionChrom?

• Analytical Method Development
• And Method Validation

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AutomatedExperimentation
FusionChrom

• Chemometric platform for analytical method
  validation.
• Auto-control of instrument parameters, external
  solvent selection valves, and column switching.
• Auto-construction and export of methods and
  sequences to your Chromatography Data System
  (CDS).
• Auto-importing of results from the CDS.
• Automated analysis and reporting that meet all
  FDA ICH Guidelines.

S-Matrix Corporation www.smatrix.com
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History
FusionChrom

• Early 1990s Major Pharma Company Project
• Sponsored by an International Top 5 Pharma
  company.
• Carried out by ControlChrom BV
• Transform DOE output into HPLC methods and
  sequences

• Off-the-shelf components
• PC-controlled HPLC instrumentation
• Commercial CDS
• Commercial DOE software

• Additional components
• Software interface DOE design (.txt) ? HPLC
  (.mth, .seq)
• Software control accessory solvent valves
• Software control column switching valve

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History
FusionChrom

• Initially (mid 1990s) PE Nelson Turbochrom was
  chosen because the development toolkit had
  documented HPLC instrument control

• Peltier column oven

• Mobile phase valves
• More phases
• pH
• Buffer
• Modifier

• Column switcher

• Automated DOE-based HPLC experiments - from
  design to report - complete success

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History
FusionChrom

• How could this DOE/HPLC system be improved?
• Ease of use deeper integration
• Chromatography specific DOE interface
• Wizards for DOE design selection
• Adapt DOE to HPLC instrument parameters
• Create a method validation experiment suite
• Automate data exchange with CDS
• Expanded range of instruments and CDS

• Improvement requires a partnership
• Chromatography/automation expert
• DOE expert

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FusionChrom

• S-Matrix Corporation
• Validated DOE software in Pharmaceutical usage
• Major Pharma customer sponsoring new development
• Looking at new opportunities to expand DOE
  applications

• Da Vinci Europe (ControlChrom BV)
• Specialists in software development for
  chromatography systems (CDS)
• Partnerships with leading HPLC and CDS companies
• Validated software in Pharmaceutical usage
• Looking to improve DOE prototype

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AutomatedExperimentation
FusionChrom
E-lab notebook Interface for fast,
easy experiment setup with correct planning built
in.
Automatically builds, designs and
exports experiments to the CDS as ready-to-run.
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AutomatedExperimentation
FusionChrom
E-lab notebook Interface for fast,
easy experiment setup with correct planning built
in.
Automatically builds, designs and
exports experiments to the CDS as ready-to-run.
Auto-analyzes results and creates reports that
meet FDA and ICH guidelines. Output formats
include RTF, DOC, HTML, and PDF.
Experiments run automatically on the CDS.
FusionChrom auto-imports all results.
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FusionChrom
Pharma-guided Development Analytical Method
Validation

• Filter Validation
• Compares the response of the filtrate to that of
  a centrifuged or other appropriate control -
  quantifies filtration effect on test samples in
  the response region of interest.

• Accuracy
• The closeness of agreement between the value
  which is accepted either as a conventional true
  value or an accepted reference value and the
  value found.

• Linearity and Range
• The ability (within a given range) to obtain test
  results which are directly proportional to the
  concentration (amount) of analyte in the sample.

• Repeatability
• Precision under the same operating conditions
  over a short interval of time. Repeatability is
  also termed intra-assay precision.

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FusionChrom
Pharma-guided Development Analytical Method
Validation

• Sample Solution Stability
• Quantifies the solution stability of the drug
  substance or drug product after preparation
  according to the test method.

• Robustness (requires method development
  technology)
• The system's capacity to remain unaffected by
  small, but deliberate variations in method
  parameters and provides an indication of its
  reliability during normal usage.

• Ruggedness
• The degree of reproducibility of the same sample
  under a variety of conditions analyst, column,
  equipment, lab, day, etc.

• Specificity
• The ability to assess unequivocally the analyte
  in the presence of components which may be
  expected to be present. Typically these might
  include impurities, degradants, matrix, etc.

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FusionChrom
Unsurpassed Proven Value
1. 2.5 FTE Years method validation (MV) effort
per Project Life. 2. MV cost per project
625,000. 3. Therefore, per project

• Minimum time saved using FusionChrom 60.

• Minimum dollars saved using FusionChrom
  375,000.

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Automated Experimentation
FusionChrom

• 21 CFR 11 Compliant - compliance features include
  full audit trail, e-signing Permissions/Authoritie
  s, and work flow administration.

• Automation - allows for easy tracking of aberrant
  data. Reduces the need for costly Analysis Lab
  Investigation Reports (ALIRs).

• Easy setup of DOE-based experiments -
  tremendously facilitates rigorous practice.

• Method Connectivity early methods developed
  using other tools can be optimized and/or
  validated using FusionChrom.

• Platform independence - works with PerkinElmer?
  TotalChrom?, Waters? Millennium?32 and Empower,
  and Varian? Galaxie?
• (and others in 2004).

• Simple documentation review - easy to defend and
  communicate.

• Standardized reporting - reports meet all FDA and
  ICH guidelines.