Method for producing human diploid cell encephalitis B inactivated vaccine

Abstract

The invention relates to the technical field of biology, in particular to a method for producing a human diploid cell encephalitis B inactivated vaccine. The method sequentially comprises the following steps of: resuscitating and subculturing a human diploid cell strain; culturing the human diploid cell strain by using a multi-stage bioreactor; inoculating an encephalitis B virus strain, and performing virus multiplication culture; harvesting a virus culture solution; and inactivating the virus culture solution, performing ultrafiltration, purifying, adding a glycoprotein protective agent, and preparing the vaccine. Human diploid cells are used as a cell matrix, so that the vaccine is safe and is free from exogenous factor pollution; the human diploid cells are cultured by the bioreactor through stage-by-stage linear amplification, so that the large-scale production of the vaccine with low cost, high quality, safety and stability is easy to implement; and the titer of the virus harvested solution is subjected to sampling inspection every day, so that the high expression of the harvested virus culture is ensured, and production quality is ensured.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a production method of Japanese encephalitis inactivated vaccine. Background technique [0002] Japanese encephalitis is mainly transmitted by the bite of the Culex tritaeniorhynchus mosquito. The virus enters the human body through the mosquito bite and first replicates in local tissues and lymph nodes, and spreads to other parts for further replication to produce viremia. In the case of brain tissue damage, the virus passes through the blood-cerebrospinal fluid barrier and invades the central nervous system, resulting in encephalitis. Once the onset, the fatality rate and sequelae of the disease are higher. At present, preventive vaccination is an effective means to prevent and treat the disease. [0003] At present, there are mainly four kinds of vaccines widely used in the market: purified mouse brain inactivated vaccine, hamster kidney cell inactivated vaccine, Japanese enceph...

AI Technical Summary

Problems solved by technology

Purified and inactivated mouse brain vaccine is prepared by inoculating the infected mice with the virus and taking the brain tissue, which is homogenized, clarified, impurity removed, concentrated and inactivated. Difficult and expensive to produce on a large scale

During the preparation of hamster kidney cell inactivated and attenuated live vaccines, there are also sex proteins of mouse origin and pollution in production.

Although the Vero cell inactivated JE vaccine is relatively easy to achieve large-scale production, there is a problem of DNA residues