【作者】 马岩松；

【导师】 魏峰；

【作者基本信息】 吉林农业大学 ， 生物物理学， 2011， 硕士

【摘要】 现代生物技术一般认为包括基因工程技术、细胞工程技术、酶工程技术和发酵工程技术,而这些技术的发展几乎都与细胞培养有密切关系,特别是在医药领域的发展,细胞培养更具有特殊的作用和价值。细胞培养在整个生物技术产业的发展中起到了很关键的核心作用。细胞培养的发展,培养基的质量又是关键,而培养基的主要成份中动物血清对细胞的生长繁殖发挥着重要甚至是难以替代的作用。在动物血清的应用中牛血清又是最为广泛的,所以牛血清是医药生物技术产品中重要的原材料之一。保证牛血清质量也是促进生物制品质量提高的重要环节。新生牛血清作为生物制品,尤其是疫苗的生产主要原料,其质量直接关系到疫苗质量,因此对新生牛血清中病毒检测尤为重要,如：牛腹泻病毒、牛腺病毒、牛细小病毒、呼肠孤病毒、狂犬病病毒、牛副流感病毒等,检查方法一般为细胞培养法、血吸附法检测法及免疫荧光抗体检查法。本文主要研究细胞培养法、血吸附法检测法和免疫荧光抗体检查法检测新生牛血清的检测时间及检测准确度,为疫苗生产提供质量保证,使新生牛血清病毒检测方法完全满足GMP要求。新生牛血清系从14小时内未进食的新生牛采血分离血清,经除菌过滤后制成,牛血清生产过程中不得任意添加其他物质成分。新生牛血清用于生产前应逐批进行蛋白质含量、血红蛋白、大肠杆菌噬菌体、渗透压摩尔浓度、无菌检查、支原体检查、细菌内毒素检查以及病毒检查,本文仅讨论病毒检查的内容,对30组供试品使用细胞培养法及免疫荧光抗体检查法进行检测,检测结果应为阴性,符合要求。更多还原

【Abstract】 Generally, modern biological technology has been included genetic engineering, cellular engineeering, enzyme engineering technology and fermentation engineering technology, the developpment of these techniques almost all have relationship with the technology of cell cultu-re, es- pecially, the cell culture has more special action and value in development of medical field. The technology of cell culture plays an essential role in the development of biotechnology industry. Development of the cell culture technology, the quality of the medium is pivotal, but the main ingredients of animal medium for cells to grow breeding is the serum which play an important even irreplaceable role. In the application of animal serum the bovine serum is the most extens- ive, so the bovine serum is one of the important raw materials for the pharmaceuti-cal biotechnology product. Ensuring the quality of bovine serum is also an important part of promoting the quality of biological products.The newborn bovine serum as the raw materials of the biological products, especially the production of vaccine, its quality related to production and quality of the vaccine. So the virus detection of the newborn bovine serum is particularly important. Such as:Bovine viral diarrhea virus(BVDV), Bovine adenovirus(BAV), Bovine Parvo virus(BPV), Reovirus, Rabies virus(RV) and Bovine parainfluenza virus(BPIV). etc must be detected, the method of the detection is the cell culture, blood adsorption assay and immune fluorescent antibody(IFA).This paper mainly studies the cell culture, blood adsorption assay and immune fluorescent antibody methods to test of testing time and detecting accuracy of newborn bovine serum. Make the detection method of the virus from newborn bovine serum meeting completely the require-ments of GMP.The newborn bovine serum is that take from the newborn cattle without food below 14 hours, and made after aseptic filtration, the process of producting the bovine serum can not add other material composition arbitrarily. Before the newborn bovine serum which used in the pro-duction should detect batch-by-batch for protein content, hematoglobin, escherichia coli phage, osmotic pressure molarity, asepsis check, mycoplasma inspection, bacterial endotoxin check and a virus-check. This paper discussed the contents of virus checking only in the newborn bovine serum that used the 30 batch of samples by the methods of cell culture and immune fluorescent antibody. The test results should be negative, and meets the requirement.更多还原