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