Novel methodology comparing two assay formats for the assessment of immunogenicity from clinical trial samples

Peterson DA, Pottanat TG, Denning H et al. | Bioanalysis, 13(14), 1113–1121 (2021) Keywords: assay and laboratory • immunogenicity • methodology Aim: We present a novel methodology to compare results between distinct immunogenicity assays, performed by two laboratories, for the same biotherapeutic. Materials & methods: Human serum pools from clinical trials were generated to provide representative immunogenicity titers. Pools were evaluated at two laboratories in a blinded fashion to assess the effect of assay format and laboratory change on clinical interpretation of immunogenicity results. Results: The laboratories validated two different assay formats and demonstrated comparable sensitivity and drug tolerance. Overall, the comparisons in assay format and laboratory ensured a...