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Method for detecting hydrophobicity of Omalizumab

A technology of omalizumab and detection method, which is applied in the field of chemical analysis, can solve the problems of not using patients, not particularly good affinity, affecting hydrophobicity, etc., and achieve the peak time, detection time and high specificity Effect

Active Publication Date: 2020-04-17
MAB VENTURE BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The problem with omalizumab is that: 1) it targets free IgE at pharmaceutically relevant doses, but does not target (or does not effectively target) the pathogenic species of the IgE / FcεRI complex; The pathogenic species of the FcεRI complex is not targeted; 3) it should not be used in patients with high IgE levels (for example, because the pathogenic species of the IgE / FcεRI complex is not targeted, and given that in patients high free IgE levels without dissipating over time); 4) "Type I local or systemic reactions, including anaphylaxis and anaphylactic shock, can occur when omalizumab is administered"; 5) its affinity for IgE and not particularly good
[0004] Different modifications of the Fab fragment of omalizumab will affect its hydrophobicity, which in turn will affect the binding activity of omalizumab

Method used

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  • Method for detecting hydrophobicity of Omalizumab
  • Method for detecting hydrophobicity of Omalizumab
  • Method for detecting hydrophobicity of Omalizumab

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] This embodiment provides a method for detecting the hydrophobicity of omalizumab, comprising the following steps:

[0046] (1) Dilute the MV-INV (Xolair) sample to 2 mg / mL with sample diluent, add papain, papain: Xolair=1:100 (w:w), digest at 37°C for 1h, 2h, 4h, Fab fragments and Fc fragments are formed; dilute to 1mg / mL with the initial mobile phase (75% mobile phase A+25% mobile phase B), as a sample;

[0047] The sample digestion and dilution process of step (1) is shown in Table 4 below

[0048] Table 4 Sample Digestion and Dilution Process

[0049]

[0050]

[0051] (2) The sample obtained in step (1) is added in the HPLC chromatograph, and gradient elution is carried out using chromatographic condition 1, and chromatographic condition 1 is shown in Table 5 below:

[0052] Table 5 Chromatographic conditions 1

[0053]

[0054] (3) Data analysis

[0055] The chromatogram that step (2) obtains is as figure 1 As shown (from bottom to top, enzymatic dige...

Embodiment 2

[0061] This embodiment provides a method for detecting the hydrophobicity of omalizumab. The difference from Example 1 is that step (2) adopts chromatographic condition 2, as shown in Table 7 below:

[0062] Table 7 Chromatographic conditions 2

[0063]

Embodiment 3

[0065] This example provides a method for detecting the hydrophobicity of omalizumab. The difference from Example 1 is that step (2) adopts chromatographic condition 3, as shown in Table 8 below:

[0066] Table 8 Chromatographic conditions 3

[0067]

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Abstract

The invention provides a method for detecting the hydrophobicity of Omalizumab. The detection method comprises the following steps: carrying out enzymolysis on Omalizumab by using papain to obtain a Fab fragment and an Fc fragment; and separating the Fab segment and the Fc segment by using hydrophobic chromatography-tandem high performance liquid chromatography, and performing analysis according to the spectrogram of the Fab segment to obtain the hydrophobicity of Omalizumab. The detection method provided by the invention has the advantages that the detection time is proper, the detection canbe completed within 35 to 37 minutes, the peak appearing time of the Fab fragment and the Fc fragment is proper, the separation degree of each peak is high, the specificity, accuracy and precision arehigher, and the method is stable and feasible.

Description

technical field [0001] The invention belongs to the technical field of chemical analysis, and in particular relates to a method for detecting the hydrophobicity of omalizumab. Background technique [0002] Omalizumab (Xolair) is a recombinant DNA-derived humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE), with a molecular weight of approximately 149 kD. Omalizumab is currently indicated for the treatment of moderate-to-severe persistent asthma in patients who have a positive skin test or are responsive in vitro to chronic aeroallergens and have symptoms inadequately controlled with inhaled corticosteroids. It is the world's first approved targeted therapy drug for the treatment of moderate to severe asthma. This product was first launched in the world in 2003 and has been approved in 96 countries, including the United States, the European Union, and Japan. [0003] The problem with omalizumab is that: 1) it targets free IgE at pharmaceutica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74G01N30/86G01N30/34G01N30/88
CPCG01N30/02G01N30/06G01N30/74G01N30/8634G01N30/8606G01N30/34G01N30/8679G01N30/88G01N2030/067G01N2030/065G01N2030/8831
Inventor 王少雄吕品陈鹏
Owner MAB VENTURE BIOPHARM CO LTD