Method for producing rabies vaccine for human

Abstract

The invention relates to a method for producing a rabies vaccine for human, comprising the following steps of: culturing human diploid cell lines by adopting a linear amplification technique of three or more levels of bioreactors; after the human diploid cell line in each level of bioreactor reaches 106 / ml, carrying out the vaccination on the next level of bioreactor; after the human diploid cell line in the last level of bioreactor grows on a microcarrier until the density reaches 106 / ml, vaccinating rabies virus strains; propagating viruses on cells by vaccinating the rabies virus strains,harvesting virus stock solutions, and inactivating, concentrating and purifying the harvested virus stock solutions to obtain the rabies vaccine for human. By using the linear amplification techniqueof the bioreactor to culture the human diploid cell lines, the cells do not contain exogenous pollution factors and tumorigenicity, and the residual DNA of the cells has no danger, and the rabies vaccine for human has the advantages of good immunizing effect and high safety and meets the requirement of large-scale industrial production of the rabies vaccine.

Description

Technical field [0001] The invention relates to a production method of a vaccine, in particular to a production method of a rabies vaccine for human use. Background technique [0002] Rabies is a zoonotic viral infectious disease caused by rabies virus. Once a person is bitten by a sick animal and causes disease, the virus rate is extremely high. Timely vaccination and preventive vaccination are clinically effective means to prevent and treat rabies. [0003] There are currently four types of rabies vaccines currently on the market: the first is chicken embryo and duck embryo vaccine, which has low yield and high production intensity, and there is the possibility of exogenous toxic factors; the second is hamster Kidney cell primary culture vaccines also have the problem of low vaccine yield, high production intensity, and the possibility of exogenous toxic factors; the third is the vaccine produced by Vero passage cells, which can solve the production problem but cannot guarantee...

AI Technical Summary

Problems solved by technology

Chinese Patent Publication No. is the patent application of CN1274607A, discloses a kind of method that uses spinning bottle technology to produce rabies vaccine, and virus strain is CTN strain, and this patent is owing to what adopting is spinning bottle technology, thereby production capacity is lower; Chinese Patent Publication No. is The patent application of CN1712068A discloses a method for producing rabies vaccine using diploid cells. The production process is a rotary bottle, and the virus strains are aG strain and CTN strain. Because the patent uses a rotary bottle process, the production capacity is low; The patent application with the publication number CN101028514A discloses a method for producing rabies vaccine by cultivating Vero cells in a bioreactor. The virus strain is a PV strain. Since the cell matrix used in this patent is Vero cells, there is a biological safety problem of DNA residues. Also did not use the linear amplification technology of bioreactor; Chinese Patent Publication No. is the patent application of CN101716341A, discloses the method that utilizes diploid cell to produce rabies vaccine, and cell matrix is ​​MRC-5, IMR-90, WI 38, 2BS, KMB17, the virus strain is PM strain

However, with the development of rabies vaccine production technology up to now, there are still problems of low production capacity and low vaccine quality