Method for producing human diploid cell poliomyelitis inactivated vaccine

A technology for human diploid cells and poliomyelitis, applied in the field of vaccines, can solve problems such as safety disputes, and achieve the effects of stable culture conditions, precise control of production parameters, and improved purity

Inactive Publication Date: 2012-04-11
CHENGDU KANGHUA BIOLOGICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since Vero cells are passaged cells, their safety is still controversial.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A production method of inactivated human diploid cell polio vaccine, which comprises successively recovery of human diploid cells, subculture of human diploid cells, inoculation of poliovirus, virus propagation and culture, and harvesting of virus culture fluid 1. Purification and inactivation of the virus culture solution, the subculture of the human diploid cells adopts multi-stage microcarrier bioreactor amplification and subculture, and the cell growth of each bioreactor reaches 10 6 When the concentration is 1 / ml, digest the cells to prepare a cell suspension, and enter the next-level bioreactor according to the amplification ratio of 1:10 for expansion and culture until the scale required for production is reached.

[0024] A further technical solution is that, in the multi-stage bioreactor, the cells cultured in the previous stage bioreactor are inoculated into the next stage bioreactor through a closed pipeline system for subculture.

[0025] A further technical...

Embodiment 2

[0030] A production method of inactivated human diploid cell polio vaccine, which comprises successively recovery of human diploid cells, subculture of human diploid cells, inoculation of poliovirus, virus propagation and culture, and harvesting of virus culture fluid 1. Purification and inactivation of the virus culture solution, the subculture of the human diploid cells adopts multi-stage microcarrier bioreactor amplification and subculture, and the cell growth of each bioreactor reaches 10 7 When the concentration is 1 / ml, digest the cells to prepare a cell suspension, and enter the next-level bioreactor according to the amplification ratio of 1:20 for expansion and culture until the scale required for production is reached.

[0031] A further technical solution is that, in the multi-stage bioreactor, the cells cultured in the previous stage bioreactor are inoculated into the next stage bioreactor through a closed pipeline system for subculture.

[0032] A further technical...

Embodiment 3

[0037] A production method of inactivated human diploid cell polio vaccine, which comprises successively recovery of human diploid cells, subculture of human diploid cells, inoculation of poliovirus, virus propagation and culture, and harvesting of virus culture fluid 1. Purification and inactivation of the virus culture solution, the subculture of the human diploid cells adopts multi-stage microcarrier bioreactor amplification and subculture, and the cell growth of each bioreactor reaches 10 6 When the concentration is 1 / ml, digest the cells to prepare a cell suspension, and enter the next-level bioreactor according to the amplification ratio of 1:10 for expansion and culture until the scale required for production is reached.

[0038] A further technical solution is that, in the multi-stage bioreactor, the cells cultured in the previous stage bioreactor are inoculated into the next stage bioreactor through a closed pipeline system for subculture.

[0039] A further technical...

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Abstract

The invention relates to the field of vaccines, in particular to a method for producing a human diploid cell poliomyelitis inactivated vaccine, which comprises the following steps of: restoring a human diploid cell, subculturing the human diploid cell, inoculating a poliomyelitis virus, amplifying the virus, harvesting a virus culture solution, and purifying and inactivating the virus culture solution. The subculture of the human diploid cell is multistage microcarrier bioreactor amplification subculture. In the invention, the multistage microcarrier bioreactor amplification subculture is adopted, production parameters are controlled accurately, culture conditions are stable, large-scale production is easy to realize, the yield of single batch of vaccines is also increased, and the uniform and stable quality of the product is ensured.

Description

technical field [0001] The invention relates to the field of vaccines, in particular to a production method of human diploid cell polio inactivated vaccine. Background technique [0002] Poliomyelitis is a type of acute infectious disease caused by poliovirus infection. The virus mainly invades the gray and white matter parts of the anterior horn of the polio cord, causing permanent damage to the gray matter, making the muscles innervated by these nerves weak and limbs flaccid Sexual paralysis. Occurs in infants and young children, so it is also called polio. Can cause limb paralysis, easily become permanent disability, and even life-threatening. [0003] At present, the current vaccines are oral attenuated live vaccines and inactivated vaccines. The production process of these two vaccines is roughly the same, the main difference is that the inactivated vaccine has the process of inactivation and purification. [0004] The advantages of oral attenuated live vaccines are...

Claims

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Application Information

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IPC IPC(8): A61K39/13A61P31/14
CPCY02A50/30
Inventor 赵志鹏侯文礼
Owner CHENGDU KANGHUA BIOLOGICAL PROD
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