扩张柱床吸附层析与固定柱床层析纯化单克隆抗体的比较  

Comparison of Expended Bed Adsorption Chromatography and Packed Bed ChrmatogRaphy for Monoclonal Antibody Purification

作　　者：余晓玲[1] 米力[1] 姚西英[1] 陈志南[1] 

机构地区：[1]第四军医大学国家863(西安)细胞工程基地,西安710032

出　　处：《中国生物工程杂志》2003年第1期61-69,共9页China Biotechnology

基　　金：国家"九五"科技攻关重点资助项目 (No .96-901- 0 1 -0 8)

摘　　要：为满足Ⅰ类新药二期临床的药品需求量 ,单抗生产由实验室规模扩大到中试规模 ,在目标产品的下游纯化工艺中 ,采用扩张柱床吸附技术代替一期临床实验室规模方法中的澄清、浓缩、和最初的疏水层析 ,其后的纯化步骤保持不变。由于采用新的纯化路线 ,使得制备周期缩短 2 3,处理能力由 1 0 0ml小鼠腹水扩大至 1 8～ 5 0L杂交瘤细胞培养液 ,回收率提高2 0 %以上 ,并很容易根据需要线性放大规模 ,为单抗的的产业化提供了更为简便和高效的下游纯化模式。To meet the amount of monoclonal antibody needed in phage Ⅱclinical trial,antibody production was enlarged from bench scale to pilot scale.expended bed adsorption was used to take the place of previous clarification,concentration and initial hydrophobic interaction chromatography used in bench scale method.Due to the new purification rutine,preparation cycle was 2/3 shortened,the sample volume of treatment was raised from 100ml mice ascities to 18-50L hybridoma cell culture broth,and the recovery yield improved more than 20%.meanwhile,it was easy to scale up to production scale according to needs.therefore,the application of expended bed adsorption provided a more simple and efficient downstream purification model for monoclonal antibody industrilization. ;

关 键 词：扩张柱床吸附层析 固定柱床层析 纯化 单克隆抗体 比较 中试规模 

分 类 号：R392－33[医药卫生—免疫学]