Stable anti-IgE humanized single anti-agent

A humanization and preparation technology, which is applied in non-active ingredients medical preparations, antibodies, respiratory diseases, etc., can solve the problems of inconvenient injection and use, inconvenient storage or clinical use, and high liquid viscosity.

Active Publication Date: 2008-06-18
TAIZHOU MABTECH PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The current preparation of anti-IgE humanized monoclonal antibody is made of anti-IgE humanized monoclonal antibody as the main drug, with sucrose, L-histidine, L-histidine hydrochloride and Tween-20 as auxiliary materials Freeze-dried preparation, t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] formula:

[0026] Component Content

[0027] Anti-IgE humanized monoclonal antibody 40mg / ml

[0028] Sucrose 8mg / ml

[0029] L-histidine 0.356mg / ml

[0030] L-histidine hydrochloride monohydrate 0.553mg / ml

[0031] Tween-20 0.099mg / ml

[0032] Sodium chloride 1.28mg / ml

[0033] Preparation Process:

[0034] The last step of purification of recombinant anti-IgE humanized monoclonal antibody is molecular exclusion chromatography, and the mobile phase is:

[0035] L-histidine 0.356mg / ml

[0036] L-histidine hydrochloride monohydrate 0.553mg / ml

[0037] Sodium chloride 1.28mg / ml

[0038] Purify through this step to obtain the stock solution of the recombinant anti-IgE humanized monoclonal antibody. The concentration of the recombinant anti-IgE humanized monoclonal antibody in the stock solution should be greater than 40 mg / ml.

[0039] Preparation of preparations:

[0040] Calculate the required amount of sucrose and Tween 20 according to the volume of the stock...

Embodiment 2

[0050] Example 2 (Xolair)

[0051] formula:

[0052] Component Content

[0053] Anti-IgE humanized monoclonal antibody 40mg / ml

[0054] Sucrose 28.736mg / ml

[0055] L-histidine 0.356mg / ml

[0056]L-histidine hydrochloride monohydrate 0.553mg / ml

[0057] Tween-20 0.099mg / ml

[0058] Preparation method is the same as embodiment 1

Embodiment 3

[0060] formula

[0061] Component Content

[0062] Anti-IgE humanized monoclonal antibody 20mg / ml

[0063] Sucrose 4mg / ml

[0064] Succinic acid 0.283mg / ml

[0065] Disodium succinate hexahydrate 1.08mg / ml

[0066] Tween-20 0.05mg / ml

[0067] Sodium chloride 0.64mg / ml

[0068] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses a stable anti-Ige humanized monoclonal-antibody preparation, which is prepared by anti-Ige humanized monoclonal-antibody protective-agent, buffer, surfactant and isoosmotic adjustment. The preparation disclosed by the invention has the advantages of stability and convenient usage.

Description

technical field [0001] The invention belongs to the field of biotechnology, and more specifically, the invention discloses a biological preparation. Background technique [0002] Asthma is a common disease, with total direct and indirect costs of all types of asthma treatment totaling $14 billion in the United States alone. And according to the US Centers for Disease Control (CDC) and the National Center for the Prevention of Health Statistics (PNCHS), asthma causes at least 2 million emergency room visits and more than 5,000 deaths each year. [0003] IgE is the main cause of asthma allergic symptoms, anti-IgE humanized monoclonal antibody is the first humanized therapeutic antibody (Xolair) for the treatment of asthma, and the first approved treatment designed for IgE antibody method, it can be applied to adult and adolescent patients with moderate to severe persistent asthma, for subcutaneous use, it is suitable for adult and adolescent patients (12 years old or above) w...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K9/19A61K47/34A61K47/26A61K47/16A61P11/06A61K47/18
Inventor 李晶郭亚军王皓寇庚侯盛
Owner TAIZHOU MABTECH PHARM CO LTD
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