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Developing, Analysing and Validating Bioassays and Immunoassays

5-week online academy | 2 hours per week

3 June - 8 July 2019

Online Academy

Module 1:

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Basics of biological assays
  • Definitions and clarifications on terminologies
  • Potency, immunogenicity, concentration assays
    • Immunoassays (ligand-binding assays)
    • Bioassays (cell-based assays)

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Module 2: How to develop an assay - immunoassays
  • Critical factors in assay development
    • Plates
    • Critical reagents
    • Hook effect
  • Robustness/Ruggedness

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Module 3: How to develop an assay - immunoassays, continued
  • OFAT versus DOE
  • Assay trouble shooting, e.g. matrix effects

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Module 4: How to develop an assay - bioassays
  • Critical factors in bioassay development
  • Cells, cells and more cells
  • Cell banking for non-producing cells
    • Acquisition
    • Regulation

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Module 5: Biostatistics
  • Curve fitting - PLA/ 4 and 5 PL
  • Correlation coefficient - R2
  • Applying a weighting function to a sigmoid curve
  • Relative potency assessment
    • Parallelism vs
    • Equivalence

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Module 6: Validation of an immunoassay
  • History & overview guidelines
  • The GxP system
  • Validation in detail, incl. pre-study and in-study
    • standard curve
    • quality controls
    • precision
    • accuracy
    • incurred sample reanalysis

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Module 7: Validation of a bioassay
  • Bioassays versus immunoassays
  • Specific considerations for bioassays
  • Guidelines overview

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Module 8: Assays in immunogenicity
  • Short intro into immunogenicity
  • Extra considerations: assay cut point
  • Guidelines

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Module 9: Validation versus qualification
  • Partial/Cross validation
  • Qualification
  • Parameters
  • Tiered approach vs fit for purpose

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Module 10: Assay monitoring & troubleshooting
  • Monitoring assay performance over time
  • Identifying and managing sources of assay variability
  • Analysing and optimising assay performance