Detecting human anti-therapeutic antibodies
First Claim
1. A method of detecting human anti-therapeutic antibodies in a sample from a patient, the method comprising the steps of:
- providing a first therapeutic antibody having a molecular tag attached thereto by a cleavable linkage, the molecular tag having one or more predetermined separation characteristics;
providing a second therapeutic antibody having a cleavage-inducing moiety attached thereto, the cleavage-inducing moiety having an effective proximity;
combining in an assay mixture the sample, the first therapeutic antibody, and the second therapeutic antibody under condition such that the first and second therapeutic antibodies form a complex with an anti-therapeutic antibody wherein the cleavable linkage of the first therapeutic antibody is within the effective proximity of the cleavage-inducing moiety of the second therapeutic antibody and molecular tags are released; and
separating from the assay mixture and detecting the released molecular tags to determine the presence or absence of anti-therapeutic antibodies in the sample.
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Accused Products
Abstract
The invention provides a method for detecting the presence of anti-therapeutic antibody antibodies in a patient being treated with a therapeutic antibody. In one aspect of the invention, the invention is implemented by the following steps: (i) providing a first therapeutic antibody having a molecular tag attached thereto by a cleavable linkage, the molecular tag having one or more predetermined separation characteristics; (ii) providing a second therapeutic antibody having a cleavage-inducing moiety attached thereto, the cleavage-inducing moiety having an effective proximity; (iii) combining in an assay mixture the sample, the first therapeutic antibody, and the second therapeutic antibody under condition such that the first and second therapeutic antibodies form a complex with an anti-therapeutic antibody wherein the cleavable linkage of the first therapeutic antibody is within the effective proximity of the cleavage-inducing moiety of the second therapeutic antibody and molecular tags are released; and (iv) separating from the assay mixture and detecting the released molecular tags to determine the presence or absence of anti-therapeutic antibodies in the sample.
107 Citations
11 Claims
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1. A method of detecting human anti-therapeutic antibodies in a sample from a patient, the method comprising the steps of:
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providing a first therapeutic antibody having a molecular tag attached thereto by a cleavable linkage, the molecular tag having one or more predetermined separation characteristics;
providing a second therapeutic antibody having a cleavage-inducing moiety attached thereto, the cleavage-inducing moiety having an effective proximity;
combining in an assay mixture the sample, the first therapeutic antibody, and the second therapeutic antibody under condition such that the first and second therapeutic antibodies form a complex with an anti-therapeutic antibody wherein the cleavable linkage of the first therapeutic antibody is within the effective proximity of the cleavage-inducing moiety of the second therapeutic antibody and molecular tags are released; and
separating from the assay mixture and detecting the released molecular tags to determine the presence or absence of anti-therapeutic antibodies in the sample. - View Dependent Claims (2, 3, 4)
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5. A method of detecting human anti-therapeutic antibodies in a sample from a patient, the method comprising the steps of:
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providing a first therapeutic antibody having a molecular tag attached thereto by a cleavable linkage, the molecular tag having one or more predetermined separation characteristics;
providing a second therapeutic antibody having a capture moiety;
combining in an assay mixture the sample, the first therapeutic antibody, and the second therapeutic antibody under condition such that the first and second therapeutic antibodies form a complex with an anti-therapeutic antibody;
separating the complex from unbound first therapeutic antibody by capturing the complex with a capture agent the specifically binds to the capture moiety, the capture agent being attached to a solid phase support;
cleaving the cleavable linkages of first therapeutic antibody of the complex to release molecular tags; and
separating and detecting the released molecular tags to determine the presence or absence of anti-therapeutic antibodies in the sample. - View Dependent Claims (6, 7, 8, 9, 10, 11)
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Specification