The AAPS journalHumansAntibodiesMonoclonalHumanizedDrug Tolerance
Revisiting the Anti-Drug Antibody Assay Drug Tolerance of a Commercial Biological Product.
James Zanghi, Nancy Yu, Benjamin T Andrews, Phyllis Chan, Maxime Usdin, Cecilia Chiu, WeiYu Lin, Alyse Lin, Yuan Song
Published: 202510.1208/s12248-025-01186-8
Abstract
Drug tolerance (DT) is a critical attribute of anti-drug antibody (ADA) assays for assessing clinical immunogenicity. We present a unique situation where a previously approved commercial product, atezolizumab, required re-assessment of the assay DT t…
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