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Method for culturing chicken pox-herpes zoster vaccine virus with high-level human diploid cell

A technology of human diploid cells and diploid cells, applied in the direction of viruses/bacteriophages, methods based on microorganisms, biochemical equipment and methods, etc., can solve the problems of low vaccine production yield and inapplicability to large-scale production, and achieve The effect of high yield

Active Publication Date: 2013-05-01
JIANGSU JIANAN BIOLOGICAL TECH
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0002] The existing varicella-zoster virus vaccine production yield is low and cannot be applied to large-scale production

Method used

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  • Method for culturing chicken pox-herpes zoster vaccine virus with high-level human diploid cell
  • Method for culturing chicken pox-herpes zoster vaccine virus with high-level human diploid cell

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Embodiment Construction

[0015] A method for cultivating varicella-zoster vaccine virus with high-level PDL human diploid cells, comprising the following steps:

[0016] (1) Establish a master cell bank (MCB) in accordance with US FDA standards (21CFR211 and 21CFR600): take ATCC (CCL171) cell lines (from ATCC, an authoritative cell preservation institution in the United States, and the cell lines are specially designated by the US FDA and handed over to the US ATCC Management), starting at the 17th generation, after about 20 days for a total of 3-5 subcultures, about 2 billion cells were harvested, about 10 million cells per cryovial, 93-96% survival rate, about 200 tubes Store in liquid nitrogen.

[0017] (2) Working cell bank (WCB) cell culture, after 12-15 days, a total of 3-5 subcultures, subcultured in the GLP laboratory, in accordance with the preparation of clinical trial materials (CTM) requirements (21CFR58) and experimental data records , liquid nitrogen and deep-frozen (-80°C) storage (tha...

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Abstract

The invention discloses a method for culturing a chicken pox-herpes zoster vaccine virus with a high-level human diploid cell. The method comprises the steps of establishing a main cell bank: taking an ATCC (American Type Culture Collection) (CCL171) cell strains at a 17th generation at the beginning according to United States FDA (Food and Drug Administration) standards, subculturing for totally 3-5 times in approximately 20 days, storing collected cells in liquid nitrogen with a cryovial, conducting working cell bank cell culture, horizontally synchronously monitoring diploid cell population doubling, and producing a vaccine with the cell strains having diploid cell population doubling levels above 2.5. With the adoption of the method, the yield of the attenuated chicken pox-herpes zoster virus vaccine is higher, and the method facilitates large-scale preparation of the herpes zoster vaccine and is applicable to scale production. The method can be used for industrial production of other live vaccines such as a hepatitis A vaccine, a rabies vaccine, a measles vaccine and a smallpox vaccine.

Description

technical field [0001] The invention relates to a method for cultivating varicella-zoster vaccine virus with high-level human diploid cells. Background technique [0002] The existing varicella-zoster virus vaccine has a low production yield and cannot be applied to large-scale production. Contents of the invention [0003] The object of the present invention is to provide a high-level human diploid cell cultured varicella-zoster virus vaccine that can obtain a higher yield of attenuated varicella-zoster virus vaccine, facilitate the large-scale preparation of herpes zoster vaccine, and is suitable for large-scale production. Herpes zoster vaccine virus method. [0004] Technical solution of the present invention is: [0005] A method for cultivating varicella-zoster vaccine virus with high-level human diploid cells is characterized in that it comprises the following steps: [0006] (1) Establish a master cell bank (MCB) in accordance with US FDA standards (21CFR211 and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N7/00C12R1/93
Inventor 莫呈钧
Owner JIANGSU JIANAN BIOLOGICAL TECH
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