Competitive ligand binding assay for detecting neutralizing antibodies

A immunogenicity assay for detecting the presence of neutralizing antibodies to a biotherapeutic protein wherein the biotherapeutic protein has been administered to a patient in need, comprising the steps of (a) obtaining a sample from the patient; (b) incubating the sample in the presence of a capt...

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Bibliographische Detailangaben
Hauptverfasser: Partridge, Michael, Shyu, Gary, Torri, Albert, Rajadhyaksha, Manoj, Georgaros, Camille
Format: Patent
Sprache:eng
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Zusammenfassung:A immunogenicity assay for detecting the presence of neutralizing antibodies to a biotherapeutic protein wherein the biotherapeutic protein has been administered to a patient in need, comprising the steps of (a) obtaining a sample from the patient; (b) incubating the sample in the presence of a capture reagent; and (c) adding a detecting reagent, wherein a decreased signal relative to a control sample indicates the presence of a neutralizing antibody to the biotherapeutic agent.