摘要
在现代生物制药工艺路线中,层析是最常用的一种技术手段。层析技术所需要的层析介质是药品监管的重点项目之一,其中层析介质的使用寿命(使用次数)必须经研究确认,并经药品监管部门审核和批准。在缩小模型上进行前瞻性研究是被广泛接受的层析介质使用寿命的研究方法。本文就层析介质使用寿命缩小模型的建立和确认作一简要综述。
Chromatography is one of the most popular techniques in modern biopharmaceutical manufacturing.To improve the safety and efficacy of the biopharmaceuticals,the usage of chromatography medium shall be inspected by regu latory authority.The lifetime of medium shall be determined by study and checked and approved by the regulatory authority.Prospective study on scale-down model has been widely accepted to lifetime of chromatography medium.This paper reviews the establishment and verification of scale-down model of life time of chromatography.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第6期894-896,共3页
Chinese Journal of Biologicals
关键词
层析介质
使用寿命
缩小模型
Chromatography medium
Lifetime
Scale-down model
