Hayakawa T
Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tokyo, Japan.
Dev Biol Stand. 1996;88:15-8.
The current situation concerning the development of an internationally harmonized document on the technical requirements for the viral safety of biotechnology drugs (ICH viral safety document) is described. Major issues relating to harmonization of testing requirements for viral safety include: (i) clarification of scientific rationale; (ii) the way and extent of virus tests for cell line qualification and cell cultivation process evaluation; (iii) discussion of the scope, extent and frequency of virus testing on the unprocessed bulk harvest; (iv) discussion of the choice of viruses for virus clearance evaluation or process characterization study.
本文描述了关于制定生物技术药物病毒安全性技术要求的国际协调文件（ICH病毒安全性文件）的进展情况。与病毒安全性检测要求协调相关的主要问题包括：（i）科学原理的阐明；（ii）细胞系鉴定和细胞培养过程评估中病毒检测的方式和程度；（iii）未加工原液收获物病毒检测的范围、程度和频率的讨论；（iv）病毒清除评估或工艺特性研究中病毒选择的讨论。
