Analysing Bioassays and Immunoassays - Online Academy (Five 2-Hour Sessions Over 5 Weeks)

  • ID: 4267274
  • Training
  • Region: Global
  • Pharmaceutical Training International
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You will understand key techniques for validation design and implementation and how to align to regulatory standards

This course will build on your understanding of bioassays and immunoassays, helping you to come to grips with assay development, troubleshooting, performance management and more. Over 10, detailed modules you will understand key techniques for validation design and implementation and how to align to regulatory standards. In addition, you will become familiar with biostatistics and key data analysis methods.

  • Understand the basic principles of biological assays
  • Learn how to develop bioassays and immunoassays
  • Comprehend the necessary biostatistics
  • Validate an assay to meet regulatory requirements
  • Build measurement systems
  • Consider assay layout
  • Select mathematical curve models to analyse your data
  • Validate and qualify your choice of model

Over 5 weeks students will learn through:

  • 10 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 5 weeks the course is running
  • Additional content such as materials and white papers available to download

This online academy course can be accessed from Monday 6th November. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

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Module 1: Basics of biological assays

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

Module 2: How to develop an assay - immunoassays

  • Critical factors in assay development
    • Plates
    • Critical reagents
    • Hook effect
  • Robustness/Ruggedness

Module 3: How to develop an assay - immunoassays, continued

  • OFAT versus DOE
  • Assay trouble shooting, e.g. matrix effects

Module 4: How to develop an assay - bioassays

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

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

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

Module 7: Validation of a bioassay

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

Module 8: Assays in immunogenicity

  • Short intro into immunogenicity
  • Extra considerations: assay cut point
  • Guidelines

Module 9: Validation versus qualification

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

Module 10: Assay monitoring & troubleshooting

  • Monitoring assay performance over time
  • Identifying and managing sources of assay variability
  • Analysing and optimising assay performance
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Dr. Melody Sauerborn spent most of her early scientific career at prestigious institutes such as the Centers for Disease and Control Prevention in the USA. After successfully finishing her Master of Science, Dr. Sauerborn worked for several Public Relations agencies in the healthcare divisions as project manager. Additionally, she was involved from early age as the CEO of a German spin-off. Succeeding her scientific dissertation in the field of protein drugs and adverse immune responses, she founded ADA InVivo, a biotech CRO in the field of drug safety. Besides that, she also works as a consultant, is involved in another biotech start-up and functions as a speaker/ trainer at international conferences and workshops.

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown