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Clinical Chemistry 51: 1983-1985, 2005; 10.1373/clinchem.2005.053272
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(Clinical Chemistry. 2005;51:1983-1985.)
© 2005 American Association for Clinical Chemistry, Inc.

Abstracts of Oak Ridge Posters

Immunogenicity Testing by Electrochemiluminescent Detection for Antibodies Directed against Therapeutic Human Monoclonal Antibodies

Michael Moxnessa, Suzanna Tatarewicz, Dohan Weeraratne, Nancy Murakami, Danika Wullner, Dan Mytych, Vibha Jawa, Eugen Koren and Steven J. Swanson

Department of Clinical Immunology, Amgen, Inc., Thousand Oaks, CA;

aaddress correspondence to this author at: Department of Clinical Immunology, Amgen, Inc., Thousand Oaks, CA 91320-1799; fax 805-480-1306, e-mail mmoxness@amgen.com)

The first 20% of the full text of this article appears below.

Monitoring the immune response against human therapeutic monoclonal antibodies is an important component of preclinical and clinical trials to assess drug exposure, efficacy, and safety (1)(2). Detection of antibodies (analyte) directed against therapeutic antibodies (drug) is difficult because of the similarity of structure between drug and analyte and the high concentrations of drug present in serum, particularly during preclinical toxicology studies (3)(4). The purpose of this study was to develop a robust assay format applicable across species and drug compounds for rapid method development and validation.

We developed 5 assays to detect antibodies against 5 distinct monoclonal antibody therapeutic drug products. Detection was dependent on bivalent antibodies binding both biotin- and ruthenium-conjugated drug compounds (for a schematic of the assay, see Fig. 1 of the Data Supplement that accompanies the online version of this abstract at http://www.clinchem.org/content/vol51/issue10/). This "bridging" assay format eliminated the need for species–specific secondary antibodies and provided assay consistency in different serum matrices as a drug . . . [Full Text of this Article]




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