Study On Inactivated Japanese Encephalitis Vaccine Production Method

Preventive vaccine in the world within the scope of application of the right to use the effective control of infectious diseases has been greatly reduced in many common infectious diseases morbidity and mortality. With molecular biology, cell biology and other related disciplines, the rapid development of new vaccines continue to be research and development. At present, our extensive use of the vaccine include inactivated vaccines, recombinant vaccines and three types of attenuated vaccine. Of these, the most classical inactivated vaccine, the simplest, quickest, human development for its more than 200 years ago, at present most of the development of vaccines are of this type, the current developed countries have adopted a new type of purification of inactivated B brain vaccine, the immunogenicity of this vaccine, and fewer side effects, safety, good. With a new generation of more safe and effective vaccine to replace the control live attenuated JE vaccine is an inevitable trend.Some scholars in China in 1993 reported that Vero cells, purified Japanese encephalitis vaccine. Vero cells are African green monkey kidney cell, easy to cultivate a large-scale, study the stability of nuclei, no exogenous factor of pollution, non-tumorigenic, are the people WHO recommend the use of matrix used for vaccine production. Preparation of Vero cells with human vaccine, we must carry out stringent purification, so that the residual DNA vaccine in cell content of less than 100pg / dose. At present, the Ministry of Health Beijing Institute of Biological Products has received Japanese encephalitis purified Vero cell vaccine production symbol. I developed inactivated JE vaccine, the use of WHO approved for vaccine production in Vero cell substrate for virus culture by inactivated virus, purified and made into vaccine ratio, higher than the same product quality standards, are the world's leading and Product market needed. Project into production, not only occupied the domestic market, will also be quickly exported to international markets, to meet growing market demand.This thesis first inactivated vaccine production process of the research to proceed, mainly the following aspects:(1) using Vero cell culture substrate for the production of virus stock solution(2) advanced purification method to enable effective antigen purification to ensure that there is a higher level of antigen. Through purification, to remove the traditional vaccine formulations, including calf serum, cell matrix, including side effects can cause the majority of the impurities, to reduce the occurrence of side reactions.(3) determine the production process for the production of three batches of vaccine prepared qualified, high-titer vaccines. Show that the production process is feasible, safe and stable. To further test the foundation.To sum up, the completion of this thesis for inactivated JE vaccines have laid a solid foundation, there is a very important practical significance? in order to verify that eventually can become the ideal vaccine, we need to carry out substantial Other work, including the conduct of animal experiments is further evidence of safety and so on. Make it more secure and stable.