生物制剂中残余DNA的潜在危害性及其检测方法的研究进展  

Progress in study on potential hazard and test method of residual DNA in biologics

作　　者：张昀 陈兴 

机构地区：[1]北京天坛生物制品股份有限公司乙肝疫苗室,北京100024

出　　处：《中国生物制品学杂志》2014年第10期1348-1353,共6页Chinese Journal of Biologicals

摘　　要：残余DNA(residual DNA,rDNA)的监控对多数已上市或正在开发的生物制剂都是必需的。rDNA被视为与宿主相关的不纯物,阐明其潜在的危害性,运用适当方法证明其在工艺过程中被清除到可接受和/或一致性的水平,对生物制剂生产和开发至关重要。本文就rDNA的潜在危害性及其定量检测方法的研究进展作一综述。The monitoring of residual DNA（rDNA）is necessary to most of biologics in market and in development. The illustration of potential hazard of rDNA which is considered as a host-associated impurity and demonstration of removal of rDNAtoanacceptableand/orconsistentlevelsinbioprocessbyusingapplicablemethodsareveryimportanttothe production and development of biologics. This paper reviews the progress in study on of potential hazard and test method of residual DNA in biologics.

关 键 词：残余DNA 潜在危害性 检测方法 

分 类 号：R392.33[医药卫生—免疫学]