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SARS-CoV-2 inactivated vaccine and preparation method of vaccine

An inactivated vaccine, sars-cov-2 technology, applied in the field of SARS-CoV-2 inactivated vaccine and its preparation, to achieve the effects of reducing impurity content, simple operation, and reducing biosafety risks

Active Publication Date: 2020-08-25
中国生物技术股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no vaccine for the prevention of new coronavirus infection on the market. The use of cell factories to cultivate Vero cells, and then inoculate specific new coronavirus strains for virus culture and harvest to prepare new coronavirus vaccines has not been reported.

Method used

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  • SARS-CoV-2 inactivated vaccine and preparation method of vaccine
  • SARS-CoV-2 inactivated vaccine and preparation method of vaccine
  • SARS-CoV-2 inactivated vaccine and preparation method of vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041]Embodiment 1, prepare SARS-CoV-2 virus inactivated vaccine example 1

[0042] (1) The virus seed adopts the new coronavirus strain 2019nCoVWIV04-1, and the cells used for production are Vero cells;

[0043] (2) Digest and disperse the resuscitated Vero cells with trypsin substitute TrypLE Select, add 199 culture medium containing 10% newborn bovine serum, mix evenly, add to the cell factory, and culture at 37°C until a uniform monolayer;

[0044] (3) After Vero cells were cultured in a 10-layer cell factory for 6 days, the cell density was 3×10 7 cells / ml, discard the cell culture medium and add 1.6L virus maintenance solution;

[0045] (4) The virus maintenance liquid that will contain working virus seed, working virus seed titer 8.00LgCCID 50 / ml, add 1.6L virus maintenance solution containing 0.01ml working virus seed to each cell factory, and the virus is cultured in the cell factory, the culture condition is 37℃±1℃;

[0046] (5) After the virus is cultured for 3 ...

Embodiment 2

[0052] Embodiment 2, prepare SARS-CoV-2 virus inactivated vaccine example 2

[0053] (1) The virus seed adopts the new coronavirus strain 2019nCoVWIV04-1, and the cells used for production are Vero cells;

[0054] (2) Digest and disperse the resuscitated Vero cells with trypsin substitute TrypLE Select, add 199 culture medium containing 10% newborn bovine serum, mix evenly, add to the cell factory, and culture at 37°C until a uniform monolayer of Vero cells is obtained. cell;

[0055] (3) After Vero cells were cultured in a 10-layer cell factory for 6 days, the cell density was 3×10 7 cells / ml, discard the cell culture medium and add 1.6L virus maintenance solution;

[0056] (4) Add the virus maintenance solution containing the working virus species into the cell factory, and the titer of the working virus species is 8.00LgCCID 50 / ml, add 1.6L virus maintenance solution containing 0.01ml working virus seed to each cell factory, and the virus is cultured in the cell factory...

Embodiment 3

[0063] Embodiment 3, prepare SARS-CoV-2 virus inactivated vaccine example 3

[0064] (1) The virus seed adopts the new coronavirus strain 2019nCoVWIV04-1, and the cells used for production are Vero cells;

[0065] (2) Digest and disperse the resuscitated Vero cells with trypsin substitute TrypLE Select, add 199 culture medium containing 10% newborn bovine serum, mix evenly, add to the cell factory, and culture at 37°C until a uniform monolayer of Vero cells is obtained. cell;

[0066] (3) After Vero cells were cultured in a 10-layer cell factory for 6 days, the cell density was 3×10 7 cells / ml, discard the cell culture medium and add 1.6L virus maintenance solution;

[0067] (4) Add the virus maintenance solution containing the working virus species into the cell factory, and the titer of the working virus species is 8.00LgCCID 50 / ml, add 1.6L virus maintenance solution containing 0.01ml working virus seed to each cell factory, and the virus is cultured in the cell factory...

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Abstract

The invention relates to a SARS-CoV-2 inactivated vaccine and a preparation method of the vaccine. The preparation method comprises the following steps: step (1) recovery and large-scale culture of Vero cells; step (2) inoculation of working seeds, batch of virus seeds, virus culture and one-time harvest virus liquid, namely, the virus harvest liquid; step (3) obtaining an inactivated virus concentrated solution after a first virus inactivation, concentration and a second virus inactivation; step (4) obtaining a vaccine stock solution after purifying the inactivated virus concentrated solution; and step (5) preparation of semi-finished product and sub-package after the stock solution is verified to be qualified.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a SARS-CoV-2 inactivated vaccine and a preparation method thereof. Background technique [0002] The outbreak of severe acute respiratory syndrome occurred at the end of December 2019, and the results of etiological testing confirmed that it was a new type of coronavirus, and then the cells were isolated to obtain a new type of coronavirus strain. The International Committee on Taxonomy of Viruses named the new coronavirus as severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2), and the WHO named the disease caused by the virus as novel coronavirus pneumonia (coronavirus disease 2019, COVID-19). The COVID-19 epidemic has caused a global pandemic, and COVID-19 has brought great harm to the safety of people's lives and property and social development in all countries. [0003] Epidemiological studies have sh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/215A61P31/14C12N7/00C12N7/06C12N7/02C12N5/071
CPCA61K39/12A61K2039/5252A61P31/14C12N5/0686C12N7/00C12N2770/20034C12N2770/20051C12N2770/20063
Inventor 杨晓明申硕段凯李新国王泽鋆张华俊卢佳万鑫郭靖王文辉李茜施金荣孟胜利
Owner 中国生物技术股份有限公司
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