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Module 5 - Special Topic

Module 5 - Special Topic

Upon completion of this fifth module, the learner should be able to:
  1. explain the biology behind in silico immunogenicity prediction;
  2. describe in silico modeling of HLA/peptide interactions;
  3. discuss the benefits and caveats in silico modeling;
  4. discuss the differences between transgenic humanized mouse models and hematopoietic systems;
  5. list the limitations and potential solutions using humanized mouse models;
  6. describe protein therapeutics and protein engineering;
  7. discuss immunogenicity risk with respect to protein engineering;
  8. describe how to perform a risk based assessment for immunogenicity of therapeutic proteins and elucidate potential mitigation strategies;
  9. explain the immunologic mechanisms responsible for antibody responses and how such mechanisms can be impacted by current therapeutic/preventative approaches;
  10. discuss requirements to developing a risk/benefit profile for immune tolerance induction based on different preventative/therapeutic approaches;
  11. discuss the regulatory guidances for biosimilars;
  12. list the challenges of developing a therapeutic that is biosimilar to a reference standard;
  13. describe the unique characteristics of selected patient populations as related to immunogenicity; and
  14. list the features that differentiate an early immune response from a mature immune response.


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