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Module 3 - Interpretation and Reporting of Immunogenicity Results

Module 3 - Interpretation and Reporting of Immunogenicity Results

Upon completion of this third module, the learner should be able to:
  1. discuss immune responses to therapeutic protein
  2. describe immunogenicity study design strategies to assess therapeutic protein immunogenicity
  3. explain how anti-drug antibodies can affect pharmacokinetic and pharmacodynamic properties of therapeutic proteins
  4. describe how immunogenicity risk assessment can affect study design and data collection strategies
  5. describe a framework of harmonized terminology for the assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides.
  6. identify potential methods for analyzing, reporting and representing the descriptive characteristics of the anti-drug antibody response and its impact on clinical parameters.
  7. list some of immune-mediated adverse reactions to biologic drugs.
  8. discuss the importance of investigations into ADA-mediated hypersensitivity reactions to biologic drugs.
  9. list the key elements of immunogenicity risk management plan
  10. describe the differences between post-marketing commitments and post-approval monitoring for immunogenicity
  11. discuss immunological basis of adverse reactions to drugs and mAb therapeutics
  12. describe the cytokine release syndromes, associated adverse events, and the distinction between this immunotoxicology-related event and therapeutic anti-drug antibody responses


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