Method for removing endotoxin from influenza vaccine formulation

A flu vaccine and endotoxin technology, which is applied to the preparation method of peptides, chemical instruments and methods, antiviral agents, etc., can solve the problems of low processing volume, incomplete endotoxin removal methods and effects, high resistance, etc., to improve The effect of production quality

Inactive Publication Date: 2005-06-01
DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the flow rate is low, the resistance is high, the processing capacity is small, and it is not easy to scale up
[0008] Since there are many types of recombinant proteins, their separation and purification steps are different, and the requirements for the endotoxin content in the production process are also different, so the method and effect of removing endotoxin cannot be completely universal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Take a film made of polypropylene filaments with a diameter of 0.13 microns, and the density of the film is 20g / m 2 ,, at a temperature of 8 degrees, the membrane is soaked in the vaccine, the ratio of the influenza vaccine to the polypropylene medium is 20 ml / g, and the frequency of oscillation at 200 rpm is absorbed for 3 hours, and the endotoxin concentration in the solution is reduced from > 8000 EU / ml To <150EU / ml, the recovery rate of the active ingredient of the influenza vaccine is above 95%.

Embodiment 2

[0022] Take a membrane made of polypropylene filaments with a diameter of 0.26 microns, and the density of the membrane is 90g / m 2 , at a temperature of 8 degrees, the membrane is soaked in the vaccine, the ratio of the influenza vaccine to the polypropylene medium is 200 ml / g, and the frequency of 200 rpm is oscillating for 3 hours, and the endotoxin concentration in the solution is reduced from > 5000 EU / ml to <1250EU / ml, the recovery rate of the active ingredient of the influenza vaccine is above 80%.

Embodiment 3

[0024] Take a polypropylene wire with a diameter of 40 microns and assemble it into a chromatography column with a packing density of 0.5 g / cm 3 , at a temperature of 8 degrees, the silk is soaked in the vaccine, the ratio of the influenza vaccine to the polypropylene medium is 90ml / g, and the flow rate of 0.5ml / min is repeatedly filtered and adsorbed for 3 hours, and the concentration of endotoxin is reduced from 430EU / ml To 250EU / ml, the recovery rate of the active ingredient of the influenza vaccine is more than 85%.

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Abstract

The present invention is method of eliminating endotoxin from influenza vaccine. Affinity medium is filled to form chromatographic column or membrane filter, which is used in processing influenza vaccine to eliminate endotoxin through static adsorption or filtration. The present invention features that the affinity medium is polypropylene. The method of eliminating endotoxin from influenza vaccine can eliminate endotoxin pollutant from influenza vaccine preparation effectively while maintaining the effective components in the vaccine and without altering the properties of the vaccine. The present invention may be used in the influenza vaccine producing process to raise the product quality.

Description

Technical field: [0001] The invention relates to the production process of recombinant protein medicine, and particularly provides a method for removing endotoxin from influenza vaccine preparations. Background technique: [0002] With the increasing maturity of genetic engineering technology, more and more recombinant protein drugs have been developed and utilized. Since the production process involves Gram-negative Escherichia coli and the separation and purification process is complicated, it will cause endotoxin contamination. [0003] Affinity technology is an effective means of separating and purifying biomacromolecules, which mainly utilizes the principle of affinity between ligands and biomacromolecules. The ligand is covalently bonded to the porous medium through chemical bonds to obtain an affinity medium, which can be used to selectively adsorb endotoxins and achieve the goal of removing endotoxins from recombinant protein solutions. Existing affinity ligands an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145A61P31/16C07K1/36C12N7/02
Inventor 李京华邵英光丛润滋王俊德
Owner DALIAN INST OF CHEM PHYSICS CHINESE ACAD OF SCI
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