Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response.

Background: Titer methods are commonly used to characterize the magnitude of an antidrug antibody response. Assay S/N is an appealing alternative, but the circumstances under which use of signal-to-noise (S/N) is appropriate have not been well defined.

Results: We validated both titer and S/N-based methods for several therapeutics.