Methods for detecting an anti-drug antibody (ada) against an anti-tnf alpha antibody
OwnerThomas Matthewsinventor
Life of this patent
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Abstract
The present technology includes methods for detecting an anti-drug antibody (ADA) that binds an anti-TNFα antibody (target antibody) in a sample comprising incubating the sample with a composition comprising an affinity antibody and a detection antibody, and isolating and detecting the ADAs that form a complex with the affinity antibody and the detection antibody. The technology also includes methods for determining the ADA concentration in a sample and confirming that a sample comprises ADAs. The technology also includes a kit for performing any of the methods of the present technology.
Claims76
A method for detecting an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) incubating the sample with a composition comprising:
- (a) a first affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label, and
- (b) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (ii) isolating ADAs that form a complex with both the first affinity antibody and the detection antibody, wherein the ADA is isolated by contacting the complex with a second affinity label that binds to the first affinity label;
- and
- (iii) detecting the ADA by measuring a level of the detection label above a predetermined cut-point.
A method for detecting an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) contacting a sample with one or more anti-TNFα conjugates to form a complex between the ADA and the anti-TNFα conjugates;
- and
- (ii) measuring a level of anti-TNFα conjugates in the complex;
- wherein the method detects the ADA with a sensitivity less than 5 ng/ml.
A method for estimating a quantity of an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) incubating the sample with a composition comprising:
- (a) an affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label, and
- (b) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (ii) isolating ADAs that form a complex with both the affinity antibody and the detection antibody, wherein the ADA is isolated by contacting the complex with a second affinity label that binds to the first affinity label;
- (iii) detecting the ADA by measuring a level of the detection label above a predetermined cut-point;
- (iv) performing steps (i)-(iii) on a known sample having a known concentration of ADA;
- and
- (v) comparing the level of the detection label in the sample to the level of the detection label in the known sample.
A kit for detecting an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) an affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label;
- (ii) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- and
- (iii) a solid phase comprising a second affinity label, wherein the second affinity label binds to the first affinity label.
A kit for estimating a quantity of an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) an affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label;
- (ii) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (iii) a solid phase comprising a second affinity label, wherein the second affinity label binds to the first affinity label;
- and
- (iv) a positive control.
A kit for confirming that an anti-drug antibody (ADA) binds a target antibody comprising an anti-TNFα antibody comprising:
- (i) an affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label;
- (ii) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (iii) an unlabeled anti-TNFα antibody;
- and
- (iv) a solid phase comprising a second affinity label, wherein the second affinity label binds to the first affinity label.
Use of a target antibody comprising an anti-TNFα antibody for detecting an ADA that binds the target antibody in a sample comprising:
- (i) incubating the sample with a composition comprising:
- (a) a first affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label, and
- (b) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (ii) isolating ADAs that form a complex with both the first affinity antibody and the detection antibody, wherein the ADA is isolated by contacting the complex with a second affinity label that binds to the first affinity label;
- and
- (iii) detecting the ADA by measuring a level of the detection label above a predetermined cut-point.
Use of one or more anti-TNFα conjugates for detecting an anti-drug antibody (ADA) that binds a target antibody comprising an anti-TNFα antibody in a sample comprising:
- (i) contacting a sample with the one or more anti-TNFα conjugates to form a complex between the ADA and the anti-TNFα conjugates;
- and
- (ii) measuring a level of anti-TNFα conjugates in the complex;
- wherein the method detects the ADA with a sensitivity less than 5 ng/mL.
Use of a target antibody comprising an anti-TNFα antibody for estimating a quantity of an anti-drug antibody (ADA) that binds the target antibody comprising the anti-TNFα antibody in a sample comprising:
- (i) incubating the sample with a composition comprising:
- (a) an affinity antibody comprising an anti-TNFα antibody conjugated to a first affinity label, and
- (b) a detection antibody comprising an anti-TNFα antibody conjugated to a detection label;
- (ii) isolating ADAs that form a complex with both the affinity antibody and the detection antibody, wherein the ADA is isolated by contacting the complex with a second affinity label that binds to the first affinity label;
- (iii) detecting the ADA by measuring a level of the detection label above a predetermined cut-point;
- (iv) performing steps (i)-(iii) on a known sample having a known concentration of ADA;
- and
- (v) comparing the level of the detection label in the sample to the level of the detection label in the known sample.
Dependencies are inferred from the claim text.