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Stable anti-HER2 humanized antibody preparation

A technology of humanized antibodies and preparations, applied in the direction of antibodies, medical preparations with inactive ingredients, anti-tumor drugs, etc., can solve the problem that α,α-biscarboxytrehalose is expensive, not suitable for long-term storage, and is not very stable. And other issues

Active Publication Date: 2008-06-18
SHANGHAI NAT ENG RES CENT OF ANTIBODY MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The clinically applied humanized anti-HER2 antibody preparation is a freeze-dried preparation, and its excipients are L-histidine hydrochloride, L-histidine, α, α-dicarboxylated trehalose, polyoxyethylene sorbitol Fatty acid ester 20, this preparation is not only unstable and should not be placed for a long time, but also the α, α-dicarboxylated trehalose used in it is expensive, which increases the cost of medication for patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] formula:

[0023] Component Dosage

[0024] Anti-HER2 humanized antibody 20mg / ml

[0025] Sucrose 38mg / ml

[0026] L-histidine 0.32mg / ml

[0027] L-histidine hydrochloride monohydrate 0.5mg / ml

[0028] Tween-20 0.09mg / ml

[0029] Sodium chloride 4mg / ml

[0030] making process:

[0031] The final step of purification of the recombinant anti-HER2 humanized monoclonal antibody is molecular exclusion chromatography, and the mobile phase is:

[0032] L-histidine 0.32mg / ml

[0033] L-histidine hydrochloride monohydrate 0.5mg / ml

[0034] Sodium chloride 4mg / ml

[0035] After this step of purification, the stock solution of the recombinant anti-HER2 humanized monoclonal antibody is obtained, and the concentration of the recombinant anti-HER2 humanized monoclonal antibody in the stock solution should be greater than 20 mg / ml.

[0036] Preparation of preparations:

[0037] Calculate the required amount of sucrose and Tween-20 according to the volume of the stock soluti...

Embodiment 2

[0048] formula:

[0049] Component Dosage

[0050] Anti-HER2 humanized antibody 10mg / ml

[0051] Sucrose 10mg / ml

[0052] L-histidine 0.16mg / ml

[0053] L-histidine hydrochloride monohydrate 0.25mg / ml

[0054] Tween-20 0.05mg / ml

[0055] The preparation method is the same as in Example 1.

Embodiment 3

[0057] formula

[0058] Component Content

[0059] Anti-HER2 humanized antibody 20mg / ml,

[0060] Sucrose 50mg / ml

[0061] L-histidine 0.32mg / ml

[0062] L-histidine monohydrate 0.5mg / ml

[0063] Tween-80 0.09mg / ml

[0064]Sodium chloride 4mg / ml

[0065] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention discloses a humanized anti-HER2 antibody preparation, which contains humanized anti-HER2 antibody, protective agent, buffering agent, surfactant and isotonic regulator. The invention has the advantages of stability and low price.

Description

technical field [0001] The invention belongs to the field of biotechnology, and more specifically, the invention discloses a stable biological preparation. Background technique [0002] Humanized anti-HER2 antibody is a recombinant DNA-derived humanized monoclonal antibody that selectively acts on the extracellular site of human epidermal growth factor receptor-2 (HER2). This antibody belongs to IgG1 type and contains human framework region and complementarity determining region of mouse anti-p185HER2 antibody that can bind to HER2. It has been shown to inhibit the proliferation of tumor cells overexpressing HER2 in vitro and in animal experiments. In addition, this antibody is a potential mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). In vitro studies, this antibody-mediated ADCC was shown to be more effective in HER2 overexpressing cancer cells than in HER2 non-overexpressing cancer cells. more preferentially produced in cells. It has been approved by ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K39/395A61K47/26A61K47/16A61P35/00
Inventor 王皓郭亚军侯盛寇庚钱卫珠李彩辉
Owner SHANGHAI NAT ENG RES CENT OF ANTIBODY MEDICINE
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