Open AccessNovel methodology comparing two assay formats for the assessment of immunogenicity from clinical trial samples
Author(s) -
Daniel A. Peterson,
Thomas G. Pottanat,
Heather Denning,
Nicoletta Bivi,
John H. Sloan,
Hương Thị Lan Nguyễn,
Matthew M. Hufford,
Robert J. Konrad,
Michael E. Hodsdon
Publication year - 2021
Publication title -
bioanalysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.566
H-Index - 58
eISSN - 1757-6199
pISSN - 1757-6180
DOI - 10.4155/bio-2021-0087
Subject(s) - immunogenicity , pooling , assay sensitivity , titer , clinical trial , medicine , computational biology , computer science , antibody , immunology , biology , pathology , artificial intelligence , alternative medicine
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 comparable ability to detect treatment-emergent antidrug antibodies for a biotherapeutic. Conclusion: We have established an approach, using pooling of patient samples, that allows for the interlaboratory comparisons without creating duplicative results.