Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar

Guerrieri D, Horvat M, Fan J, et al. | Bioanalysis, 16(01), 33-48, (2024) Keywords: • adalimumab • antidrug antibody • biosimilars • ECL • electrochemiluminescence • GP2017 • immunogenicity • pharmacokinetics • signal-to-noise ratio • titer Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novel immunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017, an adalimumab biosimilar. Methodology/results: Bioanalytical methods used for the analysis of ADA S/N ratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratios strongly correlated with ADA titers. Correlations between ADA area under the curve and ADAmax and pharmacokinetics (PK) were...