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Dissociation liquid for dissociating drug/ADA compound and application of dissociation liquid

A dissociation solution and complex technology, applied in the field of dissociation of antigen-antibody complexes, can solve problems such as complicated operation, intense composition, and complex components of the dissociation solution

Pending Publication Date: 2020-11-24
BIO THERA SOLUTIONS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is usually no effective method for detection in the first stage, so it is easy to cause false negative judgment of ADA
[0003] The acid dissociation method of the drug / ADA complex reported in the existing literature is complex in operation, difficult to control, and violent in composition, which is easy to inactivate the antibody, and the dissociation efficiency is low, and the pH value must be adjusted after dissociation; The dissociation solution is not only complex in composition but also has the disadvantage of low dissociation efficiency

Method used

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  • Dissociation liquid for dissociating drug/ADA compound and application of dissociation liquid
  • Dissociation liquid for dissociating drug/ADA compound and application of dissociation liquid
  • Dissociation liquid for dissociating drug/ADA compound and application of dissociation liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Example 1: Preparation of the immune complex of immunoglobulin drug antibody 1 and anti-drug antibody 1

[0122] Preparation of samples to be tested:

[0123] According to the change of the drug in the human body after administration and the law of anti-drug antibody production, simulate the situation in the body, and prepare the immune complex with normal human pure serum: take antibody 1 and dilute it to 16 μg / mL with normal human pure serum; Drug antibody ADA1 (AbDSerotec, HCA204), was diluted with normal human pure serum to samples with a concentration of 200ng / mL, 140ng / mL, 40ng / mL and 20ng / mL, and then mixed with 16μg / mL of antibody 1 in equal volume respectively, 37 Incubate at ℃ for 1 hour to allow it to fully react and form immune complexes. In the above binding reaction between immunoglobulin and its antibody, the amount of immunoglobulin antibody 1 can completely bind to the antibody and is excessive. Prepare the test sample containing immune complex 1 (i.e...

Embodiment 2

[0124] Example 2: Study of Dissociated Components

[0125] (1) Detection method

[0126] Use direct ELISA to detect anti-drug antibodies in serum or plasma samples, with standard samples prepared from normal human pure serum and quality control samples with high (HQC), medium (MQC), and low (LQC) concentrations. Two replicate wells were set up for each concentration for the investigation of sensitivity, precision, accuracy and stability during detection and the evaluation of standard curve during sample determination. Use the four-parameter method of SoftMaxPRO software for curve fitting, and draw a graph on the log concentration (X)-absorbance (Y) coordinates to obtain the four parameters of the standard serum sample concentration (ie, the concentration of the anti-drug antibody standard in the sample) and absorbance The conversion equation is used to calculate the anti-drug antibody content in the serum or plasma sample to be tested on the same plate, and the average of 2 r...

Embodiment 3

[0146] Preparation of dissociation solution:

[0147] Option 1: Using water for injection as a solvent, add 0.5% sodium lauryl sulfate, 0.1% Tween-20, and 0.03% Triton X-100 in the dissociation solution, and the dissociation solution The pH is 6.4.

[0148] Scheme 2: using water for injection as a solvent, adding sodium lauryl sulfate with a mass concentration of 0.5% in the dissociation solution, and the pH of the dissociation solution is 7.4.

[0149] Preparation of samples to be tested: each sample to be tested was prepared with reference to Example 1, the difference being that the immunoglobulin drugs were replaced by Antibody 1, Antibody 2, and Antibody 3 respectively, and the anti-drug antibodies were anti-drug antibodies ADA1 (AbDSerotec, HCA204), anti-drug antibody ADA2 (AbDSerotec, HCA185), anti-drug antibody ADA3 (AbDSerotec, HCA256).

[0150] Dissociation and detection: In this example, the samples to be tested containing immunoglobulin drug antibody 1, antibody 2...

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Abstract

According to the dissociation liquid for dissociating the drug / ADA compound and the application of the dissociation liquid, the dissociation liquid can simply, conveniently, rapidly and reliably dissociate the drug / ADA compound formed by combining the drug and an anti-drug antibody (ADA) of the drug, and false negative of anti-drug antibody detection can be reduced. The dissociation liquid provided by the invention contains an anionic surfactant and / or a nonionic surfactant.

Description

technical field [0001] The invention relates to a dissociation solution for dissociation of antigen-antibody complexes, such as drug / ADA complexes, and applications thereof. Background technique [0002] Currently developed methods for clinical detection of anti-drug antibodies mainly detect anti-drug antibodies (ADA) in the free state. When the drug enters the body, the drug first stimulates the body to produce anti-drug antibody ADA, and the production of ADA increases from a small amount. The drug and ADA first form a complex (that is, drug / ADA complex), and the concentration of the drug is still at a high concentration in the body. , named as the first stage; as the concentration of the drug in the body decreases, the production of ADA increases, and the excess ADA begins to form a free state in addition to forming a complex. At this time, it can be detected by the current existing methods, named the second stage ,like figure 1 schematic diagram. However, there is usu...

Claims

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Application Information

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IPC IPC(8): G01N1/28
CPCG01N1/28
Inventor 林键
Owner BIO THERA SOLUTIONS LTD
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