Poster: Fit-for-Purpose Anti-Drug Antibody (ADA) Assay: Cut Point is More Important than Lower Limit of Quantitation (KCAS)

In view of the potential risks, the immunogenicity testing for large molecule drug has become a mandatory requirement. Initially a validated quantitative ADA assay (Method A) was used to support a clinical study. Though the assay sensitivity was far better than that specified in the draft guidance document (~ 250 ng/mL), we had to develop and validate a Cut Point (CP) based assay (Method B) to re-analyze the clinical samples. Here we have summarized performance characteristics of the quantitative ADA assay and described the validation performance of a Cut Point based, Screening, Titer and Confirmatory ADA assays.

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