Professional Training

Analysing Bioassays and Immunoassays

PTI, Online
2 days
2 days
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Course description

Analysing Bioassays and Immunoassays

This virtual classroom course will cover basic statistical processes necessary for analysis of the data from bioassays, setting up meaningful system suitability acceptance criteria and designing validation plans. Important considerations will be examined such as choosing the appropriate non-linear or linear regression fit, calculating correct residual weights, computing practical limits of sensitivity and acceptable error, and measuring non-parallelism and potency.

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Suitability - Who should attend?

This course is designed for all individuals who develop, validate, perform or monitor bioassays or immunoassays. Individuals who develop assay methodologies, assign computational and analysis criteria, measure and validate performance characteristics, evaluate and troubleshoot problem assays, or who are responsible for the quality of the data will benefit from the lessons and examples presented.

Attendees should have a basic understanding of bioassays or immunoassays.

Outcome / Qualification etc.

  • Set up smart and robust immuno- and bio-assays to analyse any biological sample for potency, concentration and immunogenicity
  • Validate bioassays to meet regulatory requirements
  • Generate realistic potency assay criteria that meet regulatory requirements
  • Understand current discussions in bioanalytical community on assay parameters and regulatory requirements
  • Analyse and troubleshoot biological assays comprehensively

Training Course Content

Session 1

Basics and how to develop an immunoassay

  • Definitions and clarifications on terminologies
  • PK, immunogenicity
    • Immunoassays (ligand-binding assays)
    • Bioassays (cell-based assays)
  • Critical factors in assay development
  • OFAT versus DOE
  • Assay troubleshooting, e.g. matrix effects

How to develop a bioassay

  • Critical factors in bioassay development
  • Cells, cells and more cells
  • Cell banking for non-producing cells


  • Curve fitting - PLA/ 4 and 5 PL
  • Correlation coefficient - R2
  • Applying a weighting function to a sigmoid curve


Validation of an immunoassay

  • History & overview guidelines
  • The GxP system
  • Validation in detail, incl. pre-study and in-study
    • Standard curve
    • Quality controls
    • Precisionaccuracy
    • Incurred sample reanalysis

Validation of a bioassay

  • Bioassays versus immunoassays
  • Specific considerations for bioassays
  • Guidelines overview

Session 3

Assays in immunogenicity

  • Short intro into immunogenicity
  • Validation ‘specials’
  • Guidelines

Validation versus qualification

  • Partial/Cross validation
  • Qualification
  • Parameters
  • Immunogenicity: Tiered approach vs fit for purpose


Relative potency assay development

  • Scope
    • Focus on cell-based relative potency assays
    • Relevant guidelines
    • ICH Q8’s lifecycle concept applied to analytical procedures
    • Statistics users vs. statisticians
  • In vitro cell-based assay development
    • Cellular substrate – general considerations
    • Assay layoutFinding the design space
    • Design of experiment (including response surface designs)
    • Case study – Root cause investigation (implementation of tools detailed in previous chapters)


Data analysis, validation and continual validation

  • Data analysis
    • 4- and 5-parameter logistic regression
    • Outlier managementSystem suitability assessment
    • Sample suitability assessment
    • Relative potency assessment
  • Validation & Qualification
    • Guidelines
    • Experimental design
    • Assessment of validation parameters
    • Format variability
    • System suitability (reprise)
  • Continual validation
    • Statistical process control charts (I-MR)

Why choose PTI

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85% had applied content during the course to their role

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