Arginine-based method for preventing aggregation of omalizumab

A technology of omalizumab and arginine, used in chemical instruments and methods, antibodies, pharmaceutical formulations, etc.

Inactive Publication Date: 2020-05-08
北大未名(合肥)生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a kind of arginine-based omalizumab anti-aggregation in order to solve the problem of whether different concentrations of arginine can prevent the aggregation of omalizumab in an environment with a pH of 4.4-6.2. aggregation method

Method used

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  • Arginine-based method for preventing aggregation of omalizumab
  • Arginine-based method for preventing aggregation of omalizumab
  • Arginine-based method for preventing aggregation of omalizumab

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment one, with reference to Figure 1~2 , an arginine-based anti-aggregation method for omalizumab, comprising the steps of:

[0065] S1. Prepare instruments, prepare electronic balance, pH meter, chromatography system, pipette gun, rProtein A filler, XK50 / 20 chromatography column (As: 1.114, HETP: 0.0213, CV: 175, H: 8.9) before the experiment;

[0066] S2. Prepare materials and consumables, and prepare materials to prepare solutions for experiments;

[0067] S3. Chromatography experiment, the chromatography experiment is carried out through the steps of rinsing, equilibration, sample loading, rinsing, elution, regeneration, pre-disinfection equilibration, disinfection, post-disinfection equilibration, secondary rinsing, and preservation;

[0068] S4, anti-aggregation experiment, the pH is adjusted by dilute hydrochloric acid, and Tris is added dropwise after centrifugation for observation;

[0069] S5, analyzing the results, analyzing the results under differe...

Embodiment 2

[0079] Embodiment two, refer to Figure 1~3 , an arginine-based anti-aggregation method for omalizumab, comprising the steps of:

[0080] S1. Prepare instruments, prepare electronic balance, pH meter, chromatography system, pipette gun, rProtein A filler, XK50 / 20 chromatography column (As: 1.114, HETP: 0.0213, CV: 175, H: 8.9) before the experiment;

[0081] S2. Prepare materials and consumables, and prepare materials to prepare solutions for experiments;

[0082] S3. Chromatography experiment, the chromatography experiment is carried out through the steps of rinsing, equilibration, sample loading, rinsing, elution, regeneration, pre-disinfection equilibration, disinfection, post-disinfection equilibration, secondary rinsing, and preservation;

[0083] S4, anti-aggregation experiment, the pH is adjusted by dilute hydrochloric acid, and Tris is added dropwise after centrifugation for observation;

[0084] S5, analyzing the results, analyzing the results under different conten...

Embodiment 3

[0106] Embodiment three, refer to Figure 1~4 , an arginine-based anti-aggregation method for omalizumab, comprising the steps of:

[0107] S1. Prepare instruments, prepare electronic balance, pH meter, chromatography system, pipette gun, rProtein A filler, XK50 / 20 chromatography column (As: 1.114, HETP: 0.0213, CV: 175, H: 8.9) before the experiment;

[0108] S2. Prepare materials and consumables, and prepare materials to prepare solutions for experiments;

[0109] S3. Chromatography experiment, the chromatography experiment is carried out through the steps of rinsing, equilibration, sample loading, rinsing, elution, regeneration, pre-disinfection equilibration, disinfection, post-disinfection equilibration, secondary rinsing, and preservation;

[0110] S4, anti-aggregation experiment, the pH is adjusted by dilute hydrochloric acid, and Tris is added dropwise after centrifugation for observation;

[0111] S5, analyzing the results, analyzing the results under different cont...

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Abstract

The invention discloses an arginine-based method for preventing aggregation of omalizumab. The arginine-based method for preventing aggregation of the omalizumab comprises the following steps: (1) preparing instruments: before experiments, preparing an electronic scale, a pH meter, a chromatographic system, a pipette, a rProtein A filler and an XK50 / 20 chromatographic column (As is 1.114, HETP is0.0213, CV is 175, and H is 8.9); (2) preparing consumable materials: preparing the materials, and producing solutions for the experiments; (3) conducting the chromatography experiment: conducting thechromatography experiment through the steps of rinsing, balancing, sample loading, leaching, eluting, regenerating, balancing before disinfecting, disinfecting, balancing after disinfecting, secondary rinsing and storing; (4) conducting the aggregation-preventing experiment: adjusting a pH value through diluted hydrochloric acid, and after centrifugal treatment is conducted, adding Tris dropwisefor observation; (5) analyzing results: analyzing the results obtained at different contents; and (6) drawing a conclusion from analysis of the results. The arginine-based method for preventing aggregation of the omalizumab covers preparation of the instruments and the consumable materials, the chromatography experiment, the aggregation-preventing experiment and drawing of the conclusion from accurate analysis of the results, the arginine-based method for preventing aggregation of the omalizumab can be reasonably and accurately expressed, and thinking is precise.

Description

technical field [0001] The invention belongs to the technical field of omalizumab purification, in particular to an arginine-based anti-aggregation method for omalizumab. Background technique [0002] Omalizumab monoclonal antibody for injection is a recombinant humanized monoclonal antibody, which is an anti-IgE targeted biological agent and the world's first approved targeted therapy drug for the treatment of moderate to severe asthma. It is marketed globally and has been approved in 96 countries, including the United States, the European Union, Japan, etc., and there have been more than 680,000 patients with cumulative exposure to omalizumab during treatment years (unsmooth). 77 allergic asthma studies have been completed. In China, it is the first biological agent for the treatment of patients with moderate to severe asthma. Its curative effect and safety are clear. The launch of this product will bring more personalized drug treatment options for patients with moderate...

Claims

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Application Information

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IPC IPC(8): C07K16/42A61K9/08A61K47/18A61K39/395A61P11/06
CPCA61K9/0019A61K9/08A61K47/183A61K2039/505A61P11/06C07K16/4291
Inventor 陈思凯李树德严锐奚军军
Owner 北大未名(合肥)生物制药有限公司
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