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Production method of encephalitis B vaccine

A production method, Japanese encephalitis technology, applied in the field of production of inactivated virus Japanese encephalitis vaccine using bioreactors, can solve the problems of restricting industrial production and clinical application of virus vaccines, unstable product quality, insufficient production capacity, etc. , to achieve the effect of ensuring uniformity and stability, eliminating instability, and increasing cell density

Active Publication Date: 2012-01-25
LIVZON GROUP VACCINE ENG
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The production process of traditional inactivated virus vaccines, such as Japanese encephalitis vaccine, mostly adopts the process of rotating bottles, fixed beds and multiple small reactors in parallel to cultivate cells and viruses. This process has insufficient production capacity and unstable product quality. Many defects limit the industrialized production and clinical application of virus vaccines

Method used

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  • Production method of encephalitis B vaccine
  • Production method of encephalitis B vaccine
  • Production method of encephalitis B vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1. Recovery of VERO cell seeds

[0033] 1.1 Source of VERO cell line

[0034] The original source of VERO cells is ATCC (No. F-12313), and the main cell bank and working cell bank were established after subculture and expansion, and stored in liquid nitrogen. The main cell is 129 passages; the working cell is 133 passages, and the cryopreservation density is 4×10 6 / ml.

[0035] 1.2 Recovery of VERO-seeded cells

[0036] Take one cell of the working bank stored in the liquid nitrogen tank, and after the warm water at 39°C melts rapidly, the cell suspension is divided into about 1×10 5 / cm2 Inoculation density transferred to 175cm 2 In the square bottle, gradually add medium (M199 containing 10% (volume / volume) fetal bovine serum (M199 dry powder medium composition see GIBCO medium manual) dropwise to 60mL, 37 ℃ and 5% CO 2 cultured in an incubator.

[0037] 2. At 175cm 2 Cultivate primary seed cells in square flasks

[0038] The revived cells were cultured for 3...

Embodiment 2

[0126] 1. The batch-to-batch stability research of the product prepared by the production method of the present invention

[0127] The detection results of the three batches of pilot culture stock solutions of 040801, 040802 and 040901 showed that there were no significant differences in virus titer, complement antigen, protein residue, sterility test and potency of the three batches of sample harvest liquid (see Table 1).

[0128] Table 1 Test results of three batches of pilot culture harvest liquid

[0129]

[0130] 2. Research on culturing VERO cells and propagating JE P3 strains in spinner bottles

[0131] VERO cells were subcultured into 2L square bottles after passage in square bottles, and then expanded and cultured at a ratio of 1:4. Three batches of 16 bottles were cultured. The cell culture conditions are as follows: the formulation of the culture medium and maintenance solution is the same as the above 6.1, the temperature is 37°C, and the rotation speed is 1 / 8 ...

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Abstract

The invention provides a production method of an encephalitis B vaccine, which comprises the following steps: adding Vero seed cells to a 300-liter bioreactor, and carrying out perfusion culture together with a microcarrier; after the perfusion culture is carried out for 5-6 days, depositing the microcarrier and the cells, replacing a culture medium with a main medium, vaccinating encephalitis B viruses, and continuously carrying out the perfusion culture; and collecting a virus culture solution, filtering, inactivating and purifying the virus culture solution. By using the method, the density of the cells for production is improved; the production capacity is improved greatly; the large-scale and high-density culture is achieved; the difference between batches of products and the instability of a culture period are eliminated; the quality of the products is guaranteed to be stable and uniform; the product quality is improved; the difficult problems of the amplification culture process of the bioreactor are solved; the high-density and large-scale culture of mammalian cells by using the bioreactor is achieved.

Description

technical field [0001] The invention relates to a production method of Japanese encephalitis vaccine, in particular to a method for producing inactivated virus Japanese encephalitis vaccine by using a bioreactor. Background technique [0002] The production process of traditional inactivated virus vaccines, such as Japanese encephalitis vaccine, mostly adopts the process of rotating bottles, fixed beds and multiple small reactors in parallel to cultivate cells and viruses. This process has insufficient production capacity and unstable product quality. Many defects limit the industrialized production and clinical application of viral vaccines. At present, the cultivation of cells and viruses using bioreactor technology has become a hotspot in the research and development of virus vaccines in the world. The Pasteur Institute of France has successfully industrialized the production of Vero cell rabies vaccine and polio vaccine with a 500L bioreactor. Significant economic and s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/12C12N7/04A61P31/14C12R1/93
Inventor 刘钿莲刘丹艾文
Owner LIVZON GROUP VACCINE ENG
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