Anti-drug antibody assay
AssigneeHoffmann-La Roche Inc.
InventorsUlrich Essig, Kay-Gunnar Stubenrauch, Rudolf Vogel, Uwe Wessels
Life of this patent
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Abstract
The invention provides an antibody binding specifically to Cynomolgus IgG characterized by not binding to Human IgG, and a method for the immunological determination of an immune complex (DA/ADA complex) of a drug antibody (DA) and an antibody against said drug antibody (anti-drug antibody, ADA) in a sample of a monkey species using a double antigen bridging immunoassay.
Claims12
1-16. (canceled)
A monoclonal antibody specifically binding to Cynomoglus IgG, wherein said monoclonal antibody does not bind to human IgG.
A method for the immunological determination of an antibody against an ADA/drug antibody (DA) complex in a monkey species sample using a sandwich immunoassay said method comprising:
- a) immobilizing a capture antibody via a specific binding pair;
- b) incubating the sample with the immobilized capture antibody;
- c) washing away excess unbound antibody;
- and
- d) detecting bound ADA in complex with the capture antibody with a tracer antibody wherein the capture antibody is
- i) a monoclonal antibody specifically binding to Cynomolgus IgG, selected from the group produced by DSM ACC2799, DSM ACC2800, DSM ACC2801, DSM ACC2802, and/or DSM ACC2803, and
- ii) does not bind to human IgG, and
- wherein the tracer antibody is an monoclonal specifically binding to human IgG and is produced by DSM ACC2708.
A method for the immunological determination of an antibody against an ADA/drug antibody (DA) complex in a monkey species sample using a sandwich immunoassay said method comprising:
- a) immobilizing a capture antibody via a specific binding pair;
- b) incubating the sample with the immobilized capture antibody;
- c) washing away excess unbound antibody;
- and
- d) detecting bound ADA in complex with the capture antibody with a tracer antibody wherein the capture antibody is
- i) a monoclonal antibody specifically binding to Cynomolgus IgG, selected from the group produced by DSM ACC2799, DSM ACC2800, DSM ACC2801, DSM ACC2802, and/or DSM ACC2803, and
- ii) does not bind to human IgG, and
- wherein the tracer antibody is an monoclonal specifically binding to human and is produced by DSM ACC2708.
Dependencies are inferred from the claim text.