Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 48, Issue 3, Pages 897-901Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jpba.2008.07.012
Keywords
Enzyme immunoassay; Biomarker; Monoclonal antibody; ELISA; Antibody interference
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Therapeutic monoclonal antibodies (MoAb) have become important tools in the treatment of numerous diseases. Many of these MoAb are present in the blood at very high levels due to high dosing and long half-lives. Quantification of biomarkers bound by these therapeutic MoAb can be an important factor in determining efficacy and dosing requirements. However, quantitation of these biomarkers with reasonable accuracy can be very difficult to accomplish due to concomitant binding of the therapeutic MoAb. We describe here a novel method for quantifying total (free plus bound) biomarker concentration in the presence of high levels of therapeutic MoAb using a single non-competing MoAb in a capture/elution format. This assay has the capability to accurately detect and quantitate circulating ng/ml biomarker levels in the presence of 200 mu g/ml or more of therapeutic MoAb. (c) 2008 Elsevier B.V. All rights reserved.
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