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Avian influenza virus inactivated vaccine and preparation method thereof

An inactivated vaccine and avian influenza technology, which is applied to the preparation method and the product field obtained by the method, can solve the problem of late start of large-scale industrialized animal cell culture, no large-scale production of avian influenza inactivated vaccine, staying in the starting period, problems such as laboratory scale, to achieve the effect of reducing the factors of human operation, improving the uniformity, and improving the degree of automation

Inactive Publication Date: 2012-07-25
SINOPHARM YANGZHOU VAC BIOLOGICAL ENG CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In my country's biopharmaceutical technology industry, the large-scale industrialized cultivation of animal cells started relatively late, far behind the international advanced level. The cell culture scale and application of bioreactors in most domestic biopharmaceutical production enterprises are still in the initial stage and the laboratory scale. Slower development
There are more than 100 domestic human and veterinary vaccine manufacturers, and currently only 3 to 5 domestic vaccine manufacturers use reactors for animal cell culture technology to produce vaccines, less than 10%
[0005] In addition, there is currently no technology for large-scale production of inactivated avian influenza vaccines using cells and bioreactors

Method used

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  • Avian influenza virus inactivated vaccine and preparation method thereof
  • Avian influenza virus inactivated vaccine and preparation method thereof

Examples

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preparation example Construction

[0039] In the present invention, the preparation method of bird flu inactivated vaccine comprises the steps:

[0040] 1) subculture and cultivation of cells for seedling production;

[0041] 2) The virus adapts to cell domestication;

[0042] 3) Optionally, establishing virus seed batches;

[0043] 4) Cultivation of virus for making seedlings;

[0044] 5) Harvesting of virus liquid for making seedlings;

[0045] 6) Optionally, make a finished vaccine.

[0046] In the present invention, step 3) is optional, that is to say, the preparation method of the present invention may only include steps 1), 2), 4), 5), and 6). Preferably, the present invention includes steps 1) to 6).

[0047] In the present invention, step 6) can adopt the methods well known in the art or the methods described in the present invention, and thus is also optional. Even if step 6) is omitted, it still belongs to the scope of the present invention. Of course, preferably, step 6) is included in the pre...

Embodiment 1

[0132] Selection of bioreactor

[0133] Hangzhou AMP's rapid flow bioreactor, 100L culture volume.

[0134] Selection of cells for seedling production

[0135] (1) Canine kidney cells MDCK (purchased from China Veterinary Drug Administration) were selected as cells for seedling production.

[0136] (2) Cell generation

[0137] The 1st to 10th passage cells are defined as primitive cells, the 10th to 20th passages are defined as basic cells, the 20th to 35th passages are designated as working cells, and the production cells must be controlled within 40 passages. Stored in liquid nitrogen, the shelf life is set at 36 months.

[0138] (3) Cell characteristics

[0139] According to the current "Chinese Veterinary Pharmacopoeia" (2010 Edition) appendix to test, there should be no bacteria, mold, mycoplasma and foreign virus contamination, sensitive to H9 subtype avian influenza virus.

[0140] Poison seeds for making seedlings

[0141] (1) The virus seed used for mak...

Embodiment 2-3

[0161] Except that the African green monkey kidney cell line VERO (purchased from the China Veterinary Drug Control Institute) and the chicken embryo fibroblast cell line DF-1 (purchased from the China Veterinary Drug Control Institute) were selected, other steps were the same as in Example 1, Obtain inactivated bird flu vaccine (H9 subtype, F strain). The finished product inspection results of the obtained product are shown in Table 1.

[0162] Table 1. Test results of finished vaccine products

[0163]

[0164] It can be seen from Table 1 that the vaccine of the present invention has stable properties, moderate viscosity and good safety.

[0165] Table 2. Efficacy test results of finished vaccine products

[0166]

[0167] It can be seen from Table 2 that the vaccine of the present invention has a good immune effect.

[0168] The method for producing an inactivated avian influenza vaccine used in the present invention can not only solve the problem of chicken embryo...

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Abstract

The invention discloses an avian influenza virus inactivated vaccine and a preparation method thereof. Adaptive avian influenza viruses are adaptive to screening and domestication of a continuous cell line, and after the viruses are adaptive to cells, the number of the viruses is continuously increased until the viruses are inoculated into a cell culture bottle or a bioreactor to culture. After the obtained culture is inactivated, the obtained culture and mineral oil adjuvant are mixed and emulsified so as to prepare the vaccine. A virus reproduction method for producing an avian vaccine by means of utilizing a large quantity of chicken embryo is omitted, resource consumption is reduced, environmental pollution is decreased, biosafety is guaranteed, cost is lowered, and production efficiency is improved. By the aid of the preparation method, high-potency viruses can be produced to prepare corresponding vaccines, and requirements of fast and high-efficient vaccine production are met.

Description

technical field [0001] The invention relates to a preparation method of a vaccine and a product thereof, in particular to a preparation method of an inactivated bird flu vaccine and a product obtained by the method. Background technique [0002] The current production of inactivated avian influenza vaccines mainly adopts chicken embryo breeding method. This culture method is to inoculate the avian influenza virus into the allantoic fluid of chicken embryos. A method for obtaining a large amount of virus from the allantoic fluid of chicken embryos. Although the process is simple and easy to implement, it has serious waste of resources, high labor intensity, long production cycle, low production efficiency, difficulty in harmless disposal of tail products, and biosafety risks. [0003] Suspension culture technology has long been widely used in the international biopharmaceutical field. In the past few decades, global large-scale culture technology has developed rapidly, from ...

Claims

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Application Information

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IPC IPC(8): A61K39/145C12N5/07C12N7/00A61P31/16
Inventor 石宝兰
Owner SINOPHARM YANGZHOU VAC BIOLOGICAL ENG CO LTD
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