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Module 1 - The Field of Immunogenicity: An Introduction

Module 1 - The Field of Immunogenicity: An Introduction

This brand new comprehensive AAPS online training course was developed for those interested in learning more about the field of immunogenicity. This eCourse will provide an in depth overview of beginning through advanced topics for the assessment and interpretation of immunogenicity. As the field of biologic drug development is maturing, a wealth of knowledge has emerged on the topic of immunogenicity from the disciplines of immunology, bioanalytical sciences, protein manufacturing and formulation, and regulatory sciences.

Upon completion of this first module, the learner should be able to:
  1. describe how the immune system responds to a therapeutic protein;
  2. discuss how an immune response against a therapeutic protein can be monitored;
  3. indicated what methods and strategies can be used for immunogenicity testing, and how to integrate testing into study protocols;
  4. list the approaches used to design and validate ADA assay;
  5. discuss what to consider when developing a strategy for clinical immunogenicity assessment;
  6. describe testing strategies for assays and study design; and
  7. list key aspects in establishing a bioanalysis plan for testing immunogenicity.

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