Skip to main content

Module 2 - Principles of Immunogenicity Assay Development and Validation

Module 2 - Principles of Immunogenicity Assay Development and Validation

Upon completion of this second module, the learner should be able to:
  1. describe assay platforms, technologies, development strategies, and the tiered approach of anti- drug antibodies detection and characterization;
  2. describe the importance of developing appropriate controls;
  3. explain the difference between cell-based and competitive ligand-binding NAb assays;
  4. describe the bioanalytical challenges in developing a NAb assay;
  5. list the validation parameters involved with a NAb assay;
  6. identify drawbacks of common assay types for measuring anti-drug antibodies;
  7. describe some of the novel new methodologies for measuring anti-drug antibodies;
  8. list assay parameters that are specific to anti-drug antibody assay validations and how they differ from quantitative PK assay validations; and
  9. discuss cut-points for immunogenicity testing and how this cut-points can be titrated.


Purchase Now
Purchase the entire module —all 5 lectures—at an even greater discount by clicking the button below. Interested in just a lecture or two? Scroll down to add lectures to your cart individually. 

 ($255.00-$595.00)