Workshop and Short Course
Assay Sensitivity and Drug Tolerance are two of the essential parameters for anti-drug antibody assays. There have been heated discussions regarding the recommendation of ADA assay sensitivity at 100ng/mL in the 2016 FDA draft guidance Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Product. We will discuss FDA perspective and consideration when reviewing the levels of assay sensitivity and drug tolerance. A model case study will be included to demonstrate that assay performance is reviewed along with clinical immunogenicity data.