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Steady humanized monoclonal antibody preparation

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

Inactive Publication Date: 2012-01-25
SHANGHAI ZHANGJIANG BIOTECH 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, the stability of this preparation is not high and the viscosity of the liquid after dissolution is high, it is inconvenient to inject and use, and many patients express a strong sense of pain during use
Relatively inconvenient for both storage and clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] formula:

[0025] Component Content

[0026] Anti-IgE humanized monoclonal antibody 40mg / ml

[0027] Sucrose 8mg / ml

[0028] L-histidine 0.356mg / ml

[0029] L-histidine hydrochloride monohydrate 0.553mg / ml

[0030] Tween-20 0.099mg / ml

[0031] Sodium chloride 1.28mg / ml

[0032] making process:

[0033] The last step of purification of recombinant anti-IgE humanized monoclonal antibody is molecular exclusion chromatography, and the mobile phase is:

[0034] L-histidine 0.356mg / ml

[0035] L-histidine hydrochloride monohydrate 0.553mg / ml

[0036] Sodium chloride 1.28mg / ml

[0037] 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 40mg / ml.

[0038] Preparation of preparations:

[0039] Calculate the required amount of sucrose and Tween 20 according to the volume of the stock solut...

Embodiment 2

[0050] formula:

[0051] Component Content

[0052] Anti-IgE humanized monoclonal antibody 40mg / ml

[0053] Sucrose 28.736mg / ml

[0054] L-histidine 0.356mg / ml

[0055] L-histidine hydrochloride monohydrate 0.553mg / ml

[0056] Tween-20 0.099mg / ml

[0057] Sodium chloride 0.5mg / ml

[0058]The preparation method is the same as in Example 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 steady humanized monoclonal antibody preparation, which comprises anti-IgE (immunoglobulin E) humanized monoclonal antibody, a protecting agent, a buffering agent, a surfactant, an isoosmotic adjusting agent, and the like. The composition disclosed by the invention has the advantages of stability and convenience for use.

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. In addition, 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/19A61K47/34A61P11/06A61K47/26A61K47/16A61K47/12A61K47/10A61K47/02
Inventor 李晶王皓寇庚侯盛
Owner SHANGHAI ZHANGJIANG BIOTECH CO LTD
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