携带β-内酰胺酶基因的表达载体在哺乳动物细胞表达系统中应用风险评估  

Risk assessment of β-lactamase gene in mammalian cell expression system

作　　者：李靖 韦苏珍 贺华 陈宗梦 吴强 张雪莹 赖永洁 LI Jing;WEI Su-zhen;HE Hua;CHEN Zong-meng;WU Qiang;ZHANG Xue-ying;LAI Yong-jie(Zhuhai United Laboratories Co.,Ltd.,Zhuhai 519000,China;The United Biotechnology Co.,Ltd.,Zhuhai 519000,China;Zunyi Medical University(Zhuhai Campus),Zhuhai 519040,China)

机构地区：[1]珠海联邦制药股份有限公司,珠海519000 [2]联邦生物科技(珠海横琴)有限公司,珠海519000 [3]遵义医科大学珠海校区,珠海519040

出　　处：《中国新药杂志》2022年第18期1810-1814,共5页Chinese Journal of New Drugs

摘　　要：β-内酰胺酶基因(青霉素抗性基因)是克隆和表达载体常用的筛选标记。因β-内酰胺类抗生素如青霉素为强致敏原,《中华人民共和国药典》规定,在重组蛋白药物生产过程中,除另有规定外,不得使用青霉素或其他β-内酰胺类抗生素。β-内酰胺类抗生素具有杀细菌能力而无杀细胞能力,哺乳动物细胞培养过程中不需要添加β-内酰胺类抗生素以维持载体拷贝数和产量。但是β-内酰胺酶基因是否会给在哺乳动物细胞表达的重组蛋白带来潜在风险?本文就此进行了系统风险评估。The β-lactamase gene(ampicillin resistance gene, ampR) is the most widely used antibiotic selection marker carried on cloning/expression vectors. Due to the fact that allergic reaction to β-lactam antibiotics is a common condition, Chinese Pharmacopoeia prohibits the use of β-lactam antibiotics in the production process of therapeutic recombinant proteins. β-lactam antibiotics are bactericidal, not cytocidal, they are not used in mammalian cell culture to maintain plasmids copies and productivities. However, will β-lactamase gene pose potential risks to the final products from mammalian cell expression system? We performed a risk assessment on this issue.

关 键 词：Β-内酰胺 Β-内酰胺酶 哺乳动物 细胞 风险 

分 类 号：R95[医药卫生—药学]