摘要
随着基因工程药物产品的日益增多,对其进行严格的质量控制已愈显重要。本文分别就产品的鉴定以及纯度、活性、安全性、稳定性和一致性的评价这六个方面对该质控系统进行了阐述,同时还分析了目前所用的多种检测方法的特点。基因工程药物产品中残余杂质的限量分析也是本文着重探讨的内容之一。
As the spectrum of the recombinant DNA-derived pharmaceutical products ex- pands increasingly,it is becoming more and more improtant to establish rigorous standards for these preparations.Present review enunciates the crucial aspects of this quality control system,in- cluding the evaluation of purity,potency,safety,stability and consistency,as well as the products identification.The characteristics of various examination methods in present use are also de- scribed.In addition,the limit test for the residual impurity in biopharmaceutical products is dis- cussed intensively.
出处
《生物工程进展》
CSCD
1997年第1期13-17,共5页
Progress in Biotechnology
关键词
基因工程药物
质量控制
生物制品
rDNA-derived pharmaceutical products
quality control
impurity
