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A pharmaceutical combination preparation of recombinant human vascular endothelial growth factor receptor-antibody fusion protein

A growth factor receptor and fusion protein technology, which is applied in the field of recombinant human vascular endothelial factor receptor-antibody fusion protein drug combination preparation and its preparation, can solve problems such as complex structure, and achieve the effect of inhibiting aggregation and precipitation

Active Publication Date: 2022-03-25
HUABO BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Recombinant fusion proteins are biomacromolecular drugs with complex structures

Method used

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  • A pharmaceutical combination preparation of recombinant human vascular endothelial growth factor receptor-antibody fusion protein
  • A pharmaceutical combination preparation of recombinant human vascular endothelial growth factor receptor-antibody fusion protein
  • A pharmaceutical combination preparation of recombinant human vascular endothelial growth factor receptor-antibody fusion protein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Example 1 Stability comparison of different buffer systems

[0077] The high-concentration human recombinant vascular endothelial growth factor receptor-antibody fusion protein was replaced by G-25 desalting to the buffer salt system to be screened (as shown in Table 1), and the protein concentration was adjusted to about 10mg / mL, sterilized and filtered for later use.

[0078] The prepared samples to be studied were stored under high temperature and pressure (40°C ± 2°C), and 2 weeks later, samples were taken and sent to the SEC-HPLC test items. The test results are shown in Table 1.

[0079] Table 1 Stability comparison of different buffer systems (SEC-HPLC polymer impurity content)

[0080]

[0081] The results showed that in the citrate buffer system (pH 5.0-6.0), the higher the pH value, the more stable it was; in the buffer system concentration range of 5-20 mM, the stability of the recombinant fusion protein decreased with the increase of the buffer concentr...

Embodiment 2

[0082] Example 2 Comparison of protective effects of different stabilizers

[0083] In the buffer system of 5 mM acetate (pH 5.7), the protective effect of each stabilizer was compared, and the screened stabilizers included sugar alcohol, sodium chloride and amino acid.

[0084] High-concentration human recombinant vascular endothelial growth factor receptor-antibody fusion protein was pre-exchanged to a 5 mM acetate buffer system, each formulation was prepared by adding high-concentration stock solutions of each stabilizer, and the protein concentration was adjusted to about 10 mg / mL.

[0085] The prepared samples to be studied were stored under high temperature and pressure (40°C ± 2°C), and 4 weeks later, samples were taken and sent to the SEC-HPLC test items. The test results are shown in Table 2 and Table 3.

[0086] Table 2 Comparison of protection effects of different stabilizers (SEC-HPLC polymer impurities content)

[0087]

[0088] Table 3 Comparison of protectio...

Embodiment 3

[0092] Example 3 Recombinant Human Vascular Endothelial Growth Factor Receptor-Antibody Fusion Protein Drug Combination Preparation

[0093] The preparation is prepared according to the following formula, and the amino acid sequence of the recombinant fusion protein is shown in SEQ ID NO.: 1.

[0094] prescription

[0095] Recombinant human vascular endothelial growth factor receptor-antibody fusion protein 10mg / mL Acetate buffer system (glacial acetic acid + sodium acetate) 5mM sucrose 85g / L pH 5.7

[0096] The solvent is sterile water for injection.

[0097] The semi-finished products were aseptically distributed into vials (0.2 mL / bottle), and covered with bromobutyl rubber stoppers and aluminum caps to obtain finished products.

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Abstract

The invention relates to a recombinant human vascular endothelial factor receptor-antibody fusion protein preparation and its preparation. Specifically, the pharmaceutical combination preparation of the present invention comprises recombinant fusion protein, buffer, stabilizer, surfactant and sterile water for injection. The pharmaceutical combination preparation of the present invention can effectively inhibit side reactions such as aggregation and precipitation, hydrolysis, oxidation, and deamidation of the fusion protein, and can effectively improve the stability of the product under pressurized (high temperature, strong light irradiation, freeze-thaw, etc.), accelerated, and long-term refrigerated conditions. The stability can improve the safety of clinical use.

Description

technical field [0001] The invention relates to the field of biotechnology pharmaceutical preparations, in particular to a stable recombinant human vascular endothelial factor receptor-antibody fusion protein pharmaceutical combination preparation and a preparation method thereof. Background technique [0002] Age-related macular degeneration (AMD) is an aging structural disease in the macular region of the retina. It is clinically divided into dry AMD and wet AMD (wAMD), of which wAMD accounts for about 20% of the total AMD population. The main pathogenic mechanism of wAMD is abnormal expression of vascular endothelial growth factor (VEGF), which leads to choroidal neovascularization, which in turn leads to vascular leakage, causing macular edema, exudation and hemorrhage, thereby causing corresponding regional retinopathy, and eventually visual impairment and even visual impairment. blindness. [0003] Different vascular endothelial growth factors (VEGF) can bind to their...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61P9/10A61K38/17
CPCA61K38/179A61K39/395A61P9/10A61K2300/00
Inventor 贾慧峰朱向阳崔小培张凤雪
Owner HUABO BIOPHARM
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