摘要
生物制品的一个共同特点就是存在病毒污染的风险性。近年来,我国生物药物产业发展迅猛,随着新技术的发展以及越来越多的生物制品被批准,使用人群不断扩大,对生物制品的安全性问题提出了更高要求。与此同时,国内外关于生物制品病毒安全性控制,已经出台了一系列技术要求和指导原则。本文分析了国内外生物制品病毒安全性控制的法规,归纳提炼了可能的生物制品病毒安全性控制核心理念,可为技术法规的建立和生物制品质量控制提供参考。生物制品病毒污染的安全性只有通过贯彻病毒安全性控制理念,采取综合措施,才能得到确切的保障。
The risk of viral contamination is a feature common to biotechnology or biological products.In recent years,China’s biopharmaceutical industry has made substantial strides and developed rapidly.With the development and implementation of new technologies and the approval of more and more biological products,the user of biological products has been rapidly expanding,which puts forward higher requirements for the safety of biological products.At the same time,in China and abroad,a series of technical requirements and guidelines have been issued for viral safety control of biological products.In this paper,the regulations of viral safety control of biological products in China and abroad were analyzed,and the possible core concept of viral safety control of biological products was summarized and refined to provide reference for the establishment of technical regulations and quality control of biological products.The potential viral contamination of biotechnology or biological products can only be ensured by implementing the concept of viral safety control and taking comprehensive measures.
作者
郭怀祖
杨美花
杨汇川
公雪杰
侯盛
张华捷
李长清
董关木
李敏
孟淑芳
侯继锋
郭中平
GUO Huai-zu;YANG Mei-hua;YANG Hui-chuan;GONG Xue-jie;HOU Sheng;ZHANG Hua-jie;LI Chang-qing;DONG Guan-mu;LI Min;MENG Shu-fang;HOU Ji-feng;GUO Zhong-ping(State Key Laboratory of Antibody Medicine and Targeted Therapy,NMPA Key Laboratory of Quality Control for Therapeutic Monoclonal Antibodies,Shanghai 201203,China;Xiamen Amoytop Biotech Co.,Ltd.,Xiamen 361028,China;China National Biotec Group,Beijing 100029,China;Sinovac Biotech Ltd.,Beijing 100085,China;Shanghai Biomabs Pharmaceuticals Co.,Ltd.,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 100820,China;Institute of Blood Transfusion,Chinese Academy of Medical Science,Chengdu 610052,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Division of Biological Product Standards,Chinese Pharmacopoeia Commission,Beijing 100061,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第24期2781-2788,共8页
Chinese Journal of New Drugs
基金
国家药品监督管理局“药品医疗器械审评审批制度改革专项课题”(ZG2018-3-01)。
关键词
生物制品
病毒安全性
病毒污染
核心理念
病毒安全性评价
biotechnology or biological products
viral safety
viral contamination
core concept
viral safety evaluation
