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Drug composition preparation for recombining 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: 2018-10-19
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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  • Drug composition preparation for recombining human vascular endothelial growth factor receptor-antibody fusion protein
  • Drug composition preparation for recombining human vascular endothelial growth factor receptor-antibody fusion protein
  • Drug composition preparation for recombining human vascular endothelial growth factor receptor-antibody fusion protein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Different buffer system stability comparison of embodiment 1

[0077] The high-concentration human recombinant vascular endothelial growth factor receptor-antibody fusion protein was desalted with G-25 and changed 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 for SEC-HPLC detection. 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; in the buffer system concentration range of 5-20mM, the stability of the recombinant fusion protein decreased with the increase of the buffer concentration....

Embodiment 2

[0082] Embodiment 2 Different stabilizer protective effects contrast

[0083] In the buffer system of 5mM acetate (pH 5.7), the protective effects of various stabilizers were compared, and the screened stabilizers included sugar alcohols, sodium chloride and amino acids.

[0084] High-concentration human recombinant vascular endothelial growth factor receptor-antibody fusion protein, pre-replace the solution to 5mM acetate buffer system, prepare each prescription by adding high-concentration mother solutions of various stabilizers, and adjust the protein concentration to about 10mg / 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 for SEC-HPLC detection items. The test results are shown in Table 2 and Table 3.

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

[0087]

[0088] Table 3 Comparison of protectiv...

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] Aseptically dispense the semi-finished product into vials (0.2mL / bottle), cover with a bromobutyl rubber stopper and an aluminum cap to obtain the finished product.

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Abstract

The invention relates to a drug composition preparation for recombining human vascular endothelial growth factor receptor-antibody fusion protein and preparation thereof. The drug composition preparation specifically comprises recombination fusion protein, a buffering agent, a stabilizing agent, a surfactant and sterilize injection water. The drug composition preparation is capable of effectivelyinhibiting fusion protein accumulating and depositing, hydrolyzing, oxidizing, decarboxamidation and other side reaction, and meanwhile, the stability of the product in pressurizing (high temperature,strong light irradiating, freeze thawing, and the like), accelerating and long-term frozen storing conditions can be effectively improved; and the safety in clinical use can be improved.

Description

technical field [0001] The invention relates to the field of biotechnology drug preparations, in particular to a stable recombinant human vascular endothelial factor receptor-antibody fusion protein drug combination preparation and a preparation method thereof. Background technique [0002] Age-related macular degeneration (AMD) is an aging structural lesion in the macular area 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 the abnormal expression of vascular endothelial growth factor (VEGF), which leads to choroidal neovascularization, which in turn leads to vascular leakage, macular edema, exudation and hemorrhage, which leads to retinopathy in the corresponding area, and eventually visual impairment or even blindness. [0003] Different vascular endothelial growth factors (VEGF) can bind to their respective receptor (VEFGR) subtypes, resu...

Claims

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Application Information

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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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