van Steenis G, van Wezel A L
Dev Biol Stand. 1981;47:143-50.
Several important changes in the production process of killed poliovaccine have recently taken place or are taking place concerning cell substrate as well as production techniques. Some of the consequences of these changes for the safety testing of the vaccine will be briefly discussed. Data will be presented to show that tests in tissue culture are more sensitive than those in monkeys for the detection of residual live poliovirus in vaccine. It is concluded that there is no need for an additional test in monkeys when tests in tissue culture are carried out according to W.H.O. requirements.
近期，灭活脊髓灰质炎疫苗生产过程在细胞基质和生产技术方面发生了一些重要变化，或正在发生此类变化。本文将简要讨论这些变化对疫苗安全性检测的一些影响。文中将提供数据表明，在检测疫苗中残留的活脊髓灰质炎病毒时，组织培养试验比猴体试验更为灵敏。得出的结论是，当按照世界卫生组织的要求进行组织培养试验时，无需再进行额外的猴体试验。
