1. Novel methodology comparing two assay formats for the assessment of immunogenicity from clinical trial samples.
- Author
-
Peterson DA, Pottanat TG, Denning H, Bivi N, Sloan JH, Nguyen HT, Hufford MM, Konrad RJ, and Hodsdon ME
- Abstract
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.
- Published
- 2021
- Full Text
- View/download PDF