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本研究对连续培养多次收获工艺用于麻疹疫苗生产的可行性、疫苗维持液保护剂、冻干保护剂及冻干过程等进行了大量反复试验,结果表明在现行条件下,本生产工艺具有重复性好、成本低、投入产出率高、易于质量控制等优势。对本工艺生产疫苗进行全面检定,表明成品滴度和稳定性试验指标等均高于90版《生物制品规程》要求,并在试验基础上制定出了生产工艺流程。
In this study, a large number of repeated experiments were conducted on the feasibility of continuous culture of multiple harvesting techniques for the production of measles vaccine, vaccine maintenance fluid protectant, lyoprotectant and freeze-drying process. The results show that under the current conditions, Good repeatability, low cost, high input-output rate, easy quality control and other advantages. The process of production of vaccines for a comprehensive test showed that the finished product titers and stability test indicators are higher than the 90 version of the “Biological Products Regulations” requirements, and on the basis of the test developed a production process.