重组人组织型纤溶酶原激活剂(rt-PA)的质量控制

Quality Control of Recombinant Human TissueType Plasminogen Activator

随着重组ＤＮＡ技术的发展，生产的工业化要求对象ｒｔ－ＰＡ这样的生物产品进行严格的质量控制，这种起源于传统的质量控制系统运用了许多现代生物学的理论和先进技术，本文就ｒｔ－ＰＡ生产中有关细胞培养，纯化及终产品的质量控制等几方面进行了阐述，并对ｒｔ－ＰＡ纯度、一致性、效价的某些细节进行了分析。

With the development of recombinant DNA technology, the industrilization of production requires rigorous quality control for biological production such as rtPA. The quality control system which derived from traditional control systems have adopted current biology theory and technology. In this article some aspects of cell culture, purification and final production of rtPA were enunciated and some details of the purity, identity, potency of rtPA were analyzed.