Introduction The multi-tiered bioanalytical approaches that are commonly implemented for the assessment of immunogenicity include detection (screening, confirmation, and titer) and characterization of the anti-drug antibody. The anti-drug antibody (ADA) positive samples during the screening assay are run in a confirmatory assay. A specificity confirmatory assay eliminates any false positives detected on screen assay. The titers are used to obtain relative quantitation of ADA in the samples. The appropriate assays are developed to characterize the neutralizing capacity of antibodies in the ADA positive samples. Furthermore, assays for relevant biomarkers and/or pharmacokinetic measurements should complement ADA characterization and analysis of their in vivo impact. (Buttel et al, 2011) Figure 1- Tier Based Bioanalytical Approach for Immunogenicity Assessment Detection of Antidrug antibodies (Screening and confirmatory assay): Screening assays are the initial step of immun...