Anti-drug antibody assay

A technology of drugs and antibodies, applied in the field of determination of anti-drug antibodies

Active Publication Date: 2009-02-18
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Well-known anti-drug antibody assay formats show considerable disadvantages as described by Mire-Sluis et al.

Method used

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Embodiment Construction

[0015] According to the present invention, the term "drug antibody" means an antibody that can be administered to an individual, so it is presumed that the sample of said individual contains said drug antibody after administration. In an assay performed according to the invention, the drug antibody, capture drug antibody and tracer drug antibody comprise the "identical" antibody molecule, eg recombinantly produced using the same expression vector and comprising the same amino acid sequence. Pharmaceutical antibodies (therapeutic monoclonal antibodies) are widely used in the treatment of various diseases such as neoplastic diseases (eg, hematological and solid malignancies including non-Hodgkin's lymphoma, breast cancer and colorectal cancer). Such antibodies have been described by Levene, A.P. et al. in Journal of the Royal Society of Medicine 98 (2005) 146-152. Such antibodies are, for example, against CD20, CD22, HLA-DR, CD33, CD52, EGFR, G250, GD3, HER2, PSMA, CD56, VEGF, V...

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Abstract

The invention provides a method for the immunological determination of an antibody against a drug antibody in a sample using a double antigen bridging immunoassay comprising a capture drug antibody and a tracer drug antibody, characterized in that the capture drug antibody is a mixture of said drug antibody conjugated to the solid phase at at least two different antibody sites and the tracer drug antibody is a mixture of said drug antibody conjugated to the detectable label at at least two different antibody sites.

Description

technical field [0001] The present invention encompasses methods for assaying anti-drug antibodies and kits for use in such assays. Background technique [0002] Standard solid-phase immunoassays using monoclonal antibodies involve the formation of a complex, i.e., an adsorbed / immobilized antibody on a stationary phase (capture antibody), an antigen, and an enzyme-conjugated antibody directed against another epitope of the antigen (shown complexes between trace antibodies). Thus, a sandwich is formed: stationary phase - capture antibody - antigen - tracer antibody. In this sandwich-catalyzed reaction, the activity of the antibody-conjugated enzyme is directly proportional to the antigen concentration in the incubation solution. Because the capture and tracer antibodies bind to different epitopes of the antigen, the standard sandwich approach is also known as a double-antigen bridging immunoassay. Hoesel, W. et al. reported an anti-EPO double antigen bridging assay in J. I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/68
CPCG01N33/686G01N33/54393G01N33/54353G01N33/543G01N33/68G01N33/53G01N2470/04G01N33/6854
Inventor W·赫斯尔K-G·施图本拉赫R·福格尔
Owner F HOFFMANN LA ROCHE & CO AG
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