Burstyn D G, Hageman T C
Alkermes, Inc., Cambridge, MA, USA.
Dev Biol Stand. 1996;88:73-9.
This paper provides an overview of the fundamentals of viral inactivation and clearance studies required for mammalian cell culture-derived biotechnological products. Strategies and considerations for evaluating the potential of purification processes to inactivate or remove adventitious or endogenous viruses are also discussed. The principles are illustrated by presenting data derived from the evaluation of clinical manufacturing processes for recombinant human interferon-beta and recombinant soluble CD4.
本文概述了哺乳动物细胞培养衍生生物技术产品所需的病毒灭活和清除研究的基本原理。还讨论了评估纯化工艺灭活或去除外源或内源病毒潜力的策略和注意事项。通过展示来自重组人干扰素-β和重组可溶性CD4临床生产工艺评估的数据来说明这些原理。
