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Production and purification process of a hemorrhagic fever vaccine

A technology for vaccine production and hemorrhagic fever, applied to biochemical equipment and methods, microorganisms, antibody medical components, etc., can solve the problems of high technical requirements, small cell volume, and large cell volume, so as to improve purification efficiency and one-time investment Less, improve the effect of cell homeostasis

Active Publication Date: 2022-04-12
罗益(无锡)生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this invention uses a cell factory, the amount of primary cells is small, the amount of cultured cells is large, the space occupied is small, no need for a rotary bottle machine, and the yield is high, but the steady state of cell culture and harvest is poor
[0004] In view of various problems such as difficult manual operation, high technical requirements, low purity, large side reactions and poor stability in the production and purification of hemorrhagic fever vaccines in the prior art, it is urgent to find a simple operation, high purity and side reaction Minor production and purification methods

Method used

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  • Production and purification process of a hemorrhagic fever vaccine
  • Production and purification process of a hemorrhagic fever vaccine
  • Production and purification process of a hemorrhagic fever vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] A hemorrhagic fever vaccine production and purification process, comprising the following steps:

[0048] (1) Cell subculture: take Vero cell 138 generation cells recovery culture and subculture expansion to 143 generation, wherein, cell culture medium is made of bovine serum (the content of bovine serum is 10% of the total volume of cell culture medium), MEM solution and additives Composition, wherein the additives include: 30mg / L inositol, 20mg / L iron sodium edetate, 20mg / L hydrolyzed soybean protein, 15mg / L phosphatidylserine and 35mg / L N-acetylneuraminic acid; 37°C Culture, the subculture ratio of the cell factory is 1:4, and the production process is a non-toxic production process;

[0049] The specific flow chart of cell passage is as follows: figure 1 As shown, the small square is 30cm 2 Cell bottle, generous to 140cm 2 Cell bottle, the ten-story cell factory culture area is 6320cm 2 ;

[0050] (2) Virus infection: after cell expansion and passage to 143 gener...

Embodiment 2

[0062] The only difference from Example 1 is that the additives include: 40mg / L inositol, 30mg / L iron sodium edetate, 50mg / L hydrolyzed soybean protein, 45mg / L phosphatidylserine and 40mg / L N-acetyl neuro acid.

Embodiment 3

[0064] The only difference from Example 1 is that the additives include: 35mg / L inositol, 28mg / L ferric sodium edetate, 42mg / L hydrolyzed soybean protein, 25mg / L phosphatidylserine and 36mg / L N-acetyl neuro acid.

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Abstract

The invention provides a production and purification process of a hemorrhagic fever vaccine, which relates to the technical field of vaccine production. The production and purification process of the hemorrhagic fever vaccine comprises the following steps: cell passage, virus infection, virus liquid acquisition, virus liquid inactivation, continuous flow centrifugation , concentration by ultrafiltration, column chromatography and filtration. The process is simple to operate, the production process is stable, the side reaction is small, and the purified product has high purity.

Description

technical field [0001] The invention relates to the technical field of vaccine production, in particular to a production and purification process of a hemorrhagic fever vaccine. Background technique [0002] Epidemic hemorrhagic fever, also known as hemorrhagic fever with renal syndrome, is a natural focal acute viral infectious disease caused by hemorrhagic fever with renal syndrome virus and transmitted by rodents. At present, hemorrhagic fever vaccine is one of the effective prevention methods for epidemic hemorrhagic fever. The main production method of hemorrhagic fever vaccine is rotary bottle production, but its back-end purification is extremely difficult, and the purity after purification is not high, and many foreign proteins cause side effects Larger, with various problems. [0003] Chinese patent CN1990041A discloses a bivalent purified vaccine of hemorrhagic fever with renal syndrome VERO cells and its industrial production method. The preparation method includ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12N7/00A61K39/12A61P31/14
CPCC12N7/00A61K39/12A61P31/14C12N2760/12134C12N2760/12151A61K2039/5252
Inventor 陈韦韦陈宣洪周富昌周琪周鸿飞周洁
Owner 罗益(无锡)生物制药有限公司
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