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

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

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 evalua...

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Bibliographic Details
Main Authors: Bivi, N. (Author), Denning, H. (Author), Hodsdon, M.E (Author), Hufford, M.M (Author), Konrad, R.J (Author), Nguyen, H.T (Author), Peterson, D.A (Author), Pottanat, T.G (Author), Sloan, J.H (Author)
Format: Article
Language:English
Published: Future Medicine Ltd. 2021
Subjects:
antibody titer
Article
assay and laboratory
blood sampling
clinical assessment
colorimetry
controlled study
drug sensitivity
drug tolerance
electrochemiluminescence
human
immunoassay
immunogenicity
laboratory test
major clinical study
methodology
prediction
validation study
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