Methods for determining anti-drug antibody isotypes

一种同种型、药物的技术，应用在生物测试、材料检验品、测量装置等方向，能够解决有害副作用等问题

Inactive Publication Date: 2013-09-11
SOC DES PROD NESTLE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, many of these drugs can have harmful side effects

Method used

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  • Methods for determining anti-drug antibody isotypes
  • Methods for determining anti-drug antibody isotypes
  • Methods for determining anti-drug antibody isotypes

Examples

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Embodiment 29

[0127] Example 29 describes an exemplary proximity-based isotyping assay of the invention for determining at least one, two, three, four, five or more ATI isotypes using FRET, For example, the presence (or absence) or level of IgA ATI, IgD ATI, IgE ATI, IgG ATI and / or IgM ATI isotypes. As a non-limiting example, combining IFX labeled with a first fluorophore ("F1") and an anti-IgA antibody labeled with a second fluorophore ("F2") with one or more ATI isotypes (e.g., IgA ATI) samples (eg, serum samples) were incubated. In some embodiments, F2 is excited by F1 only when the two fluorophores are in close proximity, and the presence and / or level of a ternary complex of F1-IFX, F2-anti-IgA and IgA ATI is indicative of a sample The presence and / or levels of IgA ATI isotypes present in

[0128] In other embodiments, the signal generated by the autoantibody isotyping proximity assay is a fluorescent signal, which can be detected by electrophoretic techniques such as capillary electr...

Embodiment 1

[0225] Example 1 New Mobility Shift Assay for Measuring Levels of Anti-TNFα Biologics

[0226] This example illustrates a new homogeneous assay for measuring anti-TNFα drug concentrations in patient samples (eg, serum) that uses size exclusion chromatography to detect binding of anti-TNFα drugs to fluorescently labeled TNFα. The assay is advantageous because it avoids the need for washing steps, uses fluorophores that allow detection in the visible and / or IR spectrum (which reduces background and serum interference issues), increases detection due to high sensitivity of fluorescent label detection The ability to have low titers of anti-TNF[alpha] drugs in patients, as well as proceed as a liquid phase reaction, reduces the chance of any epitope alteration due to attachment to a solid surface such as an ELISA plate.

[0227] In an exemplary embodiment, TNFα is treated with a fluorophore (such as Alexa 647 ) label, wherein the fluorophore can be detected by visible or infrared ...

Embodiment 2

[0231] Example 2 New Mobility Shift Assay for Measuring HACA and HAHA Levels

[0232] This example illustrates a novel homogeneous assay for measuring the concentration of autoantibodies (e.g. HACA and / or HAHA) in patient samples (e.g. serum) using size exclusion chromatography to detect these autoantibodies in combination with fluorescently labeled anti-TNFα Combination of drugs. The assay is advantageous because it avoids the need for washing steps to remove low-affinity HACA and HAHA, uses fluorophores that allow detection in the visible and / or IR spectrum (which reduces background and serum interference issues), due to The high sensitivity of fluorescent label detection increases the ability to detect low titers of HACA and HAHA in patients, as well as proceeding as a liquid phase reaction, thereby reducing the chance of any epitope alteration due to attachment to a solid surface such as an ELISA plate.

[0233] The fact that HACA was detected in 53%, 21%, and 7% of rheum...

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Abstract

The present invention provides assay methods for the determination of one or more anti-drug antibody (ADA) isotypes in a sample. As a non-limiting example, the assays of the present invention are particularly useful for determining different ADA isotypes in samples from ADA-positive patients receiving an anti-TNFa drug such as REMICADETM (infliximab) or HUMIRATM (adalimumab). The present invention also provides methods for optimizing therapy and / or reducing toxicity in subjects receiving TNFa inhibitors for the treatment of TNFa-mediated disease or disorders.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 61 / 394,269, filed October 18, 2010, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. Background of the invention [0003] Autoimmune disorders are important and widespread medical problems. For example, rheumatoid arthritis (RA) is an autoimmune disease that affects more than two million people in the United States. RA causes chronic inflammation of the joints and is often a progressive disease with the potential to lead to joint destruction and functional disability. The cause of rheumatoid arthritis is unknown, however the etiology of the disease involves genetic predisposition, infectious agents and environmental factors. In active RA, symptoms can include fatigue, lack of appetite, low-grade fever, muscle and joint pain, and stiffness. During an attack, the joints often become red, swollen, painful, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N33/68
CPCG01N33/564G01N33/94G01N33/6854G01N33/558G01N30/00
Inventor S·L·王L·奥尔穆德S·豪恩施泰因S·辛格
Owner SOC DES PROD NESTLE SA
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