Anti-drug antibody assays
AssigneeAmgen Inc.
InventorsMieke Jill MILLER, Chadwick T. KING, Mark Andrew KROENKE, Marta STARCEVIC MANNING
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Abstract
The present invention relates methods of detecting anti-drug antibodies and kits for using such assays.
Claims22
A method of detecting an anti-drug antibody (ADA) in a sample, wherein said ADA binds to denosumab, comprising mixing said sample with:
- (a) a first antibody or antibody conjugate that binds to RANKL, comprising:
- the heavy chain (HC) CDR-H1, CDR-H2, and CDR-H3 of SEQ ID NO:203, and the light chain (LC) CDR-L1, CDR-L2, and CDR-L3 of SEQ ID NO:208;
- wherein said first antibody or antibody conjugate can be attached to a solid substrate;
- (b) (i) a second antibody that binds to RANKL, wherein said second antibody comprises an amino acid sequence that differs from the first antibody by at least one amino acid in one of the six CDR sequences;
- or (ii) an osteoprotegerin (OPG) protein that binds to RANKL;
- and
- (c) a third antibody that binds to said ADA and can be linked to a detectable marker.
A diagnostic kit for detecting an anti-drug antibody (ADA) in a sample, wherein said ADA binds to denosumab, comprising:
- (a) a first antibody or antibody conjugate that binds to RANKL, comprising:
- the heavy chain (HC) CDR-H1, CDR-H2, and CDR-H3 of SEQ ID NO:203, and the light chain (LC) CDR-L1, CDR-L2, and CDR-L3 of SEQ ID NO:208;
- wherein said first antibody or antibody conjugate can be attached to a solid substrate;
- (b) (i) a second antibody that binds to RANKL, wherein said second antibody comprises an amino acid sequence that differs from the first antibody by at least one amino acid in one of the six CDR sequences;
- or (ii) an osteoprotegerin (OPG) protein that binds to RANKL;
- and
- (c) a third antibody that binds to said ADA and can be linked to a detectable marker;
- and
- (d) instructions for use.
An anti-RANKL antibody, or antigen binding fragment thereof, comprising a heavy chain variable domain (VH) and a light chain variable domain (VL), wherein said VH and VL comprise (i) the heavy chain CDR-H1, CDR-H2, and CDR3-H3 of SEQ ID NO:
- 139;
- and (ii) the light chain CDR-L1, CDR-L2, and CDR3 of SEQ ID NO:
- 140, wherein the CDRs are defined according to Kabat, Chothia, IMGT, AbM, North, Martin, or Contact.
Dependencies are inferred from the claim text.