疫苗制备中外源病毒检测方法

疫苗安全性是公众及药品监管机构非常关注的问题。由于疫苗生产原材料如组织、细胞基质、血清、胰蛋白酶等来源于动物,因此疫苗产品存在外源病毒污染的风险。外源病毒对人有潜在危害,实施系统性的检测和采取严格的预防措施可以有效降低外源性因子污染的风险。几十年来,某些经典的检测法已经成为广谱筛查外源病毒污染的标准方法,但其存在一定的局限性。随着大规模基因并行测序、微阵列等分子生物学检测新方法的建立,疫苗外源因子检测方法日趋多样化,增加了检测疫苗外源因子污染种类和概率。

The methods in detection of adventitious virus in preparation of vaccines

The safety of vaccine is an extremely important issue which is concerned by the public and the authorities for drug administration. The raw materials used in production of vaccine include such as tissue, cells, serum, trypsin derived from animals. Thus, there are risks of contaminating adventitiozts virus potentially harmful to human. It can reduce such risks of contamination for product safety by a comprehensive and systematic detection and regulatation strategy. For dec- ades, some traditional assays have become classical methods to detect adventitious viruses in vaccines, but they do have a certain limitation in the range for detecting viruses. It is due to the development of new detection methods based on molecular biology, such as massively parallel sequencing and micro arrays, more and more adventitious viruses can be correctively detected.