Reagent for detecting monoclonal antibody drugs and anti monoclonal antibody drug antibodies and application of reagent

An anti-drug antibody and anti-drug technology, applied in biological testing, measuring devices, material inspection products, etc., can solve the problems of reducing non-specific reactions, low signal-to-noise ratio, strong background signal of acid dissociation reagents, etc., to reduce non-specific The effect of heterosexuality

Active Publication Date: 2020-04-17
同昕生物技术(北京)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the deficiencies in the above fields, the present invention provides reagents and detection methods for the detection of monoclonal antibody drugs and anti-monoclonal antibody drug antibodies, which can effectively reduce non-specific reactions and solve the problem of strong background signals and low signal-to-noise ratios of existing acid dissociation reagents. The problem

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1. Preferred reagents for monoclonal antibody and anti-monoclonal antibody detection

[0050] (1) Preparation of related reagents

[0051] 1. Preparation of biotinylated tumor necrosis factor α (TNF-α-Biotin): Take 0.1mg Biotin-LC-NHS (Cat#21338, Thermo) (10mg / ml, 20mM PB, pH7.4) into 1ml TNF- α solution (Cat: 10602-HNAE, sinobiological) (1mg / ml, 20mM PB, pH7.4), RT (room temperature), 1h, dialyzed to remove unreacted Biotin.

[0052] 2. Preparation of biotinylated Adalimumab (Adalimumab-Biotin): The method is the same as that of biotinylated TNF-α (TNF-α-Biotin).

[0053] 3. Preparation of acridinium ester-labeled antibody: Add 0.1μg ME-DMAE-NHS (HS-11015006, heliosense) (10mg / ml, DMSO) to 1ml antibody solution (1mg / ml, 20mM PB, pH7.4), RT (room temperature), 1h, dialyze to remove unreacted acridinium ester. The method was used to prepare acridinium ester-labeled anti-adalimumab antibody (anti-Adalimumab-MDN) and acridinium ester-labeled adalimumab antibody ...

Embodiment 2

[0117] Example 2. Application of preferred reagents in the determination of Infliximab (Infliximab) and anti-Infliximab drug antibody (anti-Infliximab)

[0118] 1. Reagent preparation

[0119] Biotinylated tumor necrosis factor alpha (TNF-α-Biotin), biotinylated infliximab (Infliximab-Biotin), acridinium ester labeled anti-Infliximab antibody (anti-Infliximab-MDN), acridinium ester The preparation method of labeled infliximab (Infliximab-MDN) is the same as that described in Example 1 (1).

[0120] Acridine ester-labeled infliximab (Infliximab-MDN), acridinium ester-labeled anti-infliximab antibody (anti-Infliximab-MDN) hydrophilization treatment method (ie MDN-Infliximab-PEG400-OH and MDN -anti-Infliximab-PEG400-OH) is the same as that described in Example 1 (6).

[0121] 2. Determination method of infliximab blood drug concentration

[0122](1) Sample dilution: take 10 μL sample / calibrator (the calibrator is prepared with fetal bovine serum (Sijiqing, product number 11011...

Embodiment 3

[0145] Example 3. Application of preferred reagents in the determination of Yisaipu and anti-Yisaipu antibodies

[0146] 1. Reagent preparation

[0147] Biotinylated tumor necrosis factor α (TNF-α-Biotin), biotinylated Yisaipu, acridinium ester-labeled anti-Yisaipu antibody (anti-YSP-MDN), acridinium ester-labeled Yisaipu (YSP -MDN) is prepared as described in Example 1 (1).

[0148] Acridinium ester-labeled Yisaipu (YSP-MDN), acridinium ester-labeled anti-Yisaipu antibody (anti-YSP-MDN) hydrophilization treatment method (ie MDN-YSP-PEG400-OH and MDN-anti-YSP -PEG400-OH) is the same as described in (6) in Example 1.

[0149] 2. Determination method of Yisaipu blood drug concentration

[0150] (1) Sample dilution: take 10 μL sample / calibrator (the calibrator is prepared with fetal bovine serum (Sijiqing, product number 11011-8611), containing 0 μg / ml, 0.05 μg / ml, 0.15 μg / ml, 0.5 μg / ml , 1.5μg / ml, 5μg / ml Yisaipu), add 100μL dissociation solution (10mM glycine buffer containi...

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PUM

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Abstract

The invention relates to blood concentration detection, in particular to a reagent for detecting monoclonal antibody drugs and anti monoclonal antibody drug antibodies and application of the reagent.The reagent comprises a dissociation solution, the dissociation solution is a glycine buffer solution or an acetic acid-sodium acetate buffer solution with the pH value of 2-3 and 8-10 mM, and the dissociation solution contains Tween-20 with the volume fraction of 0.05%-0.1%, 10-15 mug/ml of mouse IgG and/or 10-15 mug/ml of human IgG. The reagent provided by the invention can effectively reduce non-specific reaction, and solves the problems of strong background signal and low signal-to-noise ratio of the existing acid dissociation reagent.

Description

technical field [0001] The invention relates to blood drug concentration detection, in particular to a reagent for detecting monoclonal antibody and anti-monoclonal antibody and application thereof. Background technique [0002] Protein drugs are all macromolecular drugs, and the foreign body of their drug composition and structure determines that these drugs are immunogenic, so the human body will produce ADA (anti-Drug antibody) against the drug. The production of ADA is not only related to the immunogenicity of drugs, but also related to factors such as drug dosage, treatment frequency, and individual differences in pharmacokinetics. Many factors affect the pharmacokinetics of macromolecular drugs, such as the patient's physical fitness, pathological state, and medication history, but the generation of ADA is one of the most important reasons. ADA directly affects the therapeutic effect of drugs mainly by blocking the combination of drugs and targets. ADA can change the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/531
CPCG01N33/531G01N33/6854G01N33/94
Inventor 肖智李全张建珍焦守恕何建伟吴智广吴凡
Owner 同昕生物技术(北京)有限公司
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