ANALYSIS OF DETERMINATION OF ANTIBODIES SPECIFIC TO THERAPEUTIC ANTIBODIES AGAINST IGE, AND THEIR APPLICATION FOR ANAPHYLAXIS

摘要

1. A method for determining an anti-drug IgE isotype antibody that binds to an anti-IgE therapeutic antibody in a sample, comprising the steps of: (a) bringing a sample, which may contain an anti-drug antibody, into contact with a mutant therapeutic antibody containing at least one mutation amino acids of a therapeutic anti-IgE antibody, wherein the relative binding affinity of the mutant therapeutic antibody to human IgE is about 10% or less of the relative affinity binding IgE therapeutic antibody to said human IgE; and (b) determining binding of an anti-drug antibody to a mutant therapeutic antibody. 2. The method of claim 1, wherein the relative binding affinity of the mutant therapeutic antibody to human IgE is about 5% or less of the relative binding affinity of the therapeutic anti-IgE antibody to human IgE. The method of claim 1, wherein the relative binding affinity of the mutant therapeutic antibody to human IgE is about 2.5% or less of the relative binding affinity of the therapeutic anti-IgE antibody to human IgE. The method of claim 1, wherein the relative binding affinity of the mutant therapeutic antibody to human IgE is about 1% or less of the relative binding affinity of the therapeutic anti-IgE antibody to human IgE. The method of claim 1, wherein the relative binding affinity is measured by comparing binding to human IgE in an ELISA. Method for determining IgE isotype antibody against drug binding