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A stable anti-vegf antibody preparation and its use

A liquid preparation and preparation technology, which is applied in the field of stable anti-VEGF antibody preparations, can solve problems such as the increase of polymers and charge isomers, product quality consistency and safety impact, and low stability of anti-VEGF antibody preparations

Active Publication Date: 2019-08-23
INNOVENT BIOLOGICS (SUZHOU) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most of the currently known anti-VEGF antibody preparations are not stable, and are prone to physical changes (such as aggregation and fragmentation) and chemical changes (such as deamidation, oxidation) during storage, resulting in the increase of polymers and charge variants. Potentially affect the quality consistency and safety of the product

Method used

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  • A stable anti-vegf antibody preparation and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Each component and content in the preparation are as shown in Table 1:

[0093] Table 1

[0094] anti-VEGF monoclonal antibody 25mg / ml Sodium acetate 1.64mg / ml Sorbitol 50mg / ml Polysorbate 80 0.7mg / ml pH 5.2

Embodiment 2

[0096] Each component and content in the preparation are as shown in Table 2:

[0097] Table 2

[0098] anti-VEGF monoclonal antibody 25mg / ml Sodium acetate 1.64mg / ml sucrose 80mg / ml

[0099] Polysorbate 20 0.4mg / ml pH 5.2

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PUM

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Abstract

The invention relates to a stable anti-VEGF antibody preparation and an application thereof, specifically the preparation comprises (i) therapeutically effective amounts of an anti-VEGF antibody, (ii) a buffer system containing 1.0-5.0mg / ml of sodium acetate trihydrate, (iii) an osmotic pressure regulator, and optionally (iv) surfactant, wherein the pH of the preparation ranges from 5.0 to 6.0. The preparation disclosed by the invention can be used for effectively reducing the physical and chemical degradation reaction rates of an anti-VEGF monoclonal antibody, improving antibody stability and prolonging the shelf life of a finished product; in addition, the invention also discloses a method for stabilizing the antibody and an application of the preparation.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a stable anti-VEGF antibody preparation and its application. Background technique [0002] Anti-VEGF monoclonal antibody drugs for treatment can specifically bind to VEGF-A and inhibit the binding of VEGF-A to VEGF-R1 and VEGF-R2, blocking PI3K-Akt / PKB and Ras-Raf-MEK-ERK and other signaling pathways It inhibits the growth, proliferation and migration of vascular endothelial cells and angiogenesis, reduces the permeability of blood vessels, blocks the blood supply of tumor tissues, inhibits the proliferation and metastasis of tumor cells, induces apoptosis of tumor cells, and produces anti-tumor effects. [0003] Most of the currently known anti-VEGF antibody preparations are not stable, and are prone to physical changes (such as aggregation and fragmentation) and chemical changes (such as deamidation, oxidation) during storage, resulting in the increase of polymers and charge varian...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K47/26A61K47/10A61K47/02A61P35/00
Inventor 汪音爵黄小乐姚宗仁
Owner INNOVENT BIOLOGICS (SUZHOU) CO LTD
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