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