Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies
作者： Kay Stubenrauch , Uwe Wessels , Ulrich Essig , Rudolf Vogel , Julia Schleypen
DOI: 10.1016/J.JPBA.2009.12.029
关键词:
摘要: Current state of the art bridging ELISA technologies for detection anti-drug antibodies (ADAs) against therapeutic bear risk false-negative results due to interference by circulating drug. Methods remove drug in sample or pre-treatment techniques such as acid dissociation immune complexes are limited, laborious and may destroy ADAs resulting again results. The complex described this publication provides a simple solution. It is designed analyze samples from cynomolgus monkeys dosed with human antibodies; it can be used all since independent specific antibody its target. generic applicability ADA assay enabled use (1) murine anti-human Fc monoclonal (MAb) capture reagent; (2) anti-cynomolgus monkey IgG MAb (3) an positive control conjugate consisting complexed IgG. In basic version, specifically detects only formed vivo. Validation revealed lower limit quantitation 15.6 ng/mL serum samples. Intra-assay inter-assay precision was characterized coefficient variation less than 10% accuracy within 8%. Matrix effects were low evidenced mean recovery 95%. vitro pre-incubation makes also free amenable measurement demonstrated analysis two studies different antibodies. versatile nature favors pilot pharmacokinetic safety during candidate selection help explain unexpected clearance profiles, loss efficacy events caused guide further development.
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