A pharmaceutical composition containing a fusion protein for inhibiting angiogenesis and its application

A fusion protein and angiogenesis technology, applied in the medical application field, can solve the problems of reduced protein activity, reduced therapeutic effect, toxic and side effects, etc.

Active Publication Date: 2017-06-27
CHENGDU KANGHONG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, the stability of generally recombinant fusion proteins is relatively poor, and will be affected by various environmental factors during storage, such as temperature, moderate, oxygen, ultraviolet rays, etc., which can cause various physical or chemical changes in the fusion protein, resulting in Protein aggregation, decomposition, oxidation or denaturation, etc.
These changes can reduce the activity of the protein, reduce the therapeutic effect and cause serious side effects

Method used

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  • A pharmaceutical composition containing a fusion protein for inhibiting angiogenesis and its application
  • A pharmaceutical composition containing a fusion protein for inhibiting angiogenesis and its application
  • A pharmaceutical composition containing a fusion protein for inhibiting angiogenesis and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Stability study of the original formulation of 10mg / ml FP3 fusion protein in 3ml glass ampoule at 4°C

[0035] The prescription is as follows:

[0036]

[0037] After changing the protein stock solution, aseptically dispense it into 3ml glass ampoules, reserve samples at 4°C, and measure at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and December Samples, stability determined by SEC-HPLC. The results showed that the formulation could not effectively inhibit the formation of polymers, resulting in a decrease in product purity and a decrease in affinity with VEGF, which may induce an immune response after entering the body.

[0038] Table 1. Stability of 10mg / ml FP3 fusion protein at 4°C

[0039]

[0040]

Embodiment 2

[0041] Example 2 Stability study of 10mg / ml FP3 fusion protein in 3ml glass ampoule at 4°C

[0042]

[0043] After changing the protein stock solution, aseptically dispense it into 3ml glass ampoules, reserve samples at 4°C, and measure at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and December Samples, stability determined by SEC-HPLC. The results showed that the formulation could not effectively inhibit the formation of polymers, resulting in a decrease in product purity and a decrease in affinity with VEGF, which may induce an immune response after entering the body.

[0044] Table 2. Stability of 10mg / ml FP3 fusion protein at 4°C

[0045] time (month) Exterior pH value Concentration (mg / ml) polymer(%) Affinity (pM) 0 qualified 7.7 10.1 0.2 10.7 1 qualified 7.9 10.1 2.0 9.9 2 qualified 7.7 10.7 3.2 9.3 3 qualified 7.8 10.6 5.4 8.4 6 qualified 7.7 10.3 9.9 8.1 9 qualified 7.5 10.1 13.1 8.5 12 ...

Embodiment 3

[0046] Example 3 Stability study of 10mg / ml FP3 fusion protein in 3ml glass ampoule at 4°C

[0047]

[0048] After changing the protein stock solution, aseptically dispense it into 3ml glass ampoules, reserve samples at 4°C, and measure at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and December Samples, stability determined by SEC-HPLC. The results showed that the formulation could not effectively inhibit the formation of polymers, resulting in a decrease in product purity and a decrease in affinity with VEGF, which may induce an immune response after entering the body.

[0049] Table 3. Stability of 10mg / ml FP3 fusion protein at 4°C

[0050] time (month) Exterior pH value Concentration (mg / ml) polymer(%) Affinity (pM) 0 qualified 7.9 10.2 0.3 10.4 1 qualified 7.9 10.2 1.4 10.0 2 qualified 7.8 10.6 2.6 9.7 3 qualified 7.8 10.7 3.6 8.1 6 qualified 8.1 10.5 9.4 7.9 9 qualified 8.3 10.1 18.5 9.7 12 ...

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Abstract

The invention discloses a pharmaceutical composition containing a fusion protein capable of inhibiting blood vessel hyperplasia and application thereof, specifically to the pharmaceutical composition containing the fusion protein of an extracellular structural domain 2 (Flt-2) of a vascular endothelial growth factor (VEGF) acceptor 1, extracellular structural domains 3 and 4 (KDR-3,4) of a VEGF acceptor 2 and human immune globulin 1 (IG1) Fc. The pharmaceutical composition enables the fusion protein to maintain stable and can effectively inhibit decrease of purity caused by generation of a fusion protein polymer, thereby maintaining biological activity of active components.

Description

[0001] This application is a divisional application with an application date of August 31, 2010, an application number of 201010267503.7, and an invention title of "a pharmaceutical composition containing a fusion protein that inhibits angiogenesis and its use". technical field [0002] The invention relates to the field of pharmaceutical preparations, and relates to a pharmaceutical composition comprising a fusion protein of VEGF receptor fragment and immunoglobulin Fc, and its medical application. Background technique [0003] With the development of modern cell and molecular biology, the role of cytokines and cell surface related molecules in ophthalmic diseases has been widely concerned and studied. VEGF is a mitogen in vascular endothelial cells that has the biological characteristics of increasing vascular permeability. VEGF is extremely important for angiogenesis in the fetal period, and its level decreases after birth. Under physiological conditions, VEGF is expresse...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K38/16A61K47/10A61K47/36A61K47/26A61K47/18A61K47/04A61P27/02
Inventor 柯潇郑强
Owner CHENGDU KANGHONG BIOTECH
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