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Origin News recently, the National food drug Administration announced that it would start a special approval process, and clinical trials to determine appropriate programs to encourage vaccine enterprises H1N1 Type A influenza vaccine development; If a pandemic influenza outbreak in China, emergency circumstances, the State Food and Drug Administration will be organized to coordinate the production of 11 alpha-enterprise collaborative H1N1 influenza vaccine. registered SFDA Director of the Division of Biological Products Chapter Yin Hong, China's existing 11 enterprises have access to influenza vaccine distributed by the World Health Organization influenza H1N1 strain of influenza vaccine. If the 11 existing domestic influenza vaccine can be successfully enterprises H1N1 Type A influenza vaccine approval of special permits, if the Type A H1N1 influenza pandemic in the world, a conservative estimate of annual production capacity of China to the preparation of vaccines is 360 million. If all goes well, by the end of July the first batch of Type A H1N1 influenza vaccine will be available news in the end will be 6 on 8, the State Food and Drug Administration said that if a pandemic flu outbreak in China, emergency circumstances, the State Food and Drug Administration will organize and coordinate the production of 11 alpha-enterprise collaborative H1N1 influenza vaccine. the same day, Beijing Kexing Biological Products Co., Ltd. announced that has been distributed by the World Health Organization H1N1 Type A strains of influenza vaccine, the official start of influenza vaccine H1N1 influenza "Dole look forward to blessing" of the production. In that case, the vaccine can be produced when it put into use? What will be going through a process of producing it? Produced by the vaccine clinical trials needs to be done to verify its safety and effectiveness of it? With these questions, this reporter visited the Beijing Kexing Biological Products Co., Ltd.. - pre-production ,7-8 days - chick embryo production has been in place Beijing Kexing Biological Products Co., Ltd. Deputy General Manager Wang told reporters that the production of virus vaccines, the need for a large number of 9-11 day-old chick embryo, the embryo has all ready. chick embryo by professional training companies to provide, called Hailan white chicken embryo, with low resistance even without resistance, the virus will not be injected into chicken embryos killed by their own resistance. Chick embryo to the shell white, translucent, and dark room, the light source of exposure can clearly see the embryo's blood vessels, it is easy to find the weak embryos, dead embryos. Training before the embryo to undergo a rigorous screening, disinfection before use. strain to be amplified to meet the production needs of Wang Nan, the WHO sent poisonous species is to reorganize the original seed strain of the virus to retain antigenicity of the virus, and replication capacity, reducing the pathogenicity of the virus. However, less than enough to mass production of vaccines, must be diluted, amplified by training, preparation of the virus seed grant, and verify that amplified data, for example, what kind of dilution to the concentration of better training. diluted viruses, types of cysts into the chick embryo in the urine (equivalent to the amniotic fluid of human embryonic), followed by Chicken Add confined, sterile, temperature of incubation box, so that the virus rapidly propagation. Cultured chick embryo after a certain period of time, samples of urine cysts in the liquid, and then measured virus hemagglutinin titer to determine the effectiveness of training. Access to appropriate training in order to repeat the generation of sub-toxic species, retained as a seed used for vaccine production batch, the whole process takes about 7-8 days. - high-volume production ,18-20 days - Wang Nan said that the production of a vaccine product, approximately 18-20 days, but specific time each step is not the same as in all enterprises for technological secrets. mechanical cultivation, a large number of access to the virus large-scale cultivation of virus used in a chicken embryo to reach tens of thousands of pieces, and its cultivation and harvesting processes and access to the process of granting the same seed virus, but the operation is purely mechanical. Wang said that the machine operators can reduce the manual pollution, and increase production efficiency. virus inactivation, removal of pathogenic "WHO has provided us with the live virus, although infection is very low, but We still have to come out of production to deal with the inactivated virus, remove virus pathogenicity. "Wang said, the use of inactivated virus harvest fluid-treated a certain period of time, access to inactivated virus fluid. vaccine purified high-purity liquid inactivated virus, but also for purification of liquid to preserve the vaccine virus as the active ingredient - antigen, to inactivated virus in addition to other impurities in solution (such as the chick inside the protein, inactivated by the chemical reagents, etc.) in order to avoid these impurities have an adverse reaction on the human body. the company's technical staff Zou Yong introduced by chromatography, filtration, centrifugation and other physical methods, and finally received a vaccine of high purity liquid. The needs of the whole process completed in the shortest possible time. Qingdao - friends comments time released
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