Yu Xiao-Ling, Mi Li, Yao Xi-Ying, Chen Zhi-Nan
The Fourth military medical university, National Engineering Research Center, Xi'an 710032, China.
Sheng Wu Gong Cheng Xue Bao. 2004 Mar;20(2):227-32.
Monoclonal antibody producted by continuous perfusion culture was recovered and purified by expended bed adsorption chromatography. A packed bed column XK16/20 was used for method scouting with Streamline SP adsorbent. Two expended bed columns Streamline-25 and -50 were used for method optimization and pilot scale experiment, respectively. The recovery yield of monoclonal antibody was above 90% in a 5 - 7 fold enhanced purity and 10 fold increased concentration. According to the different concentration of monoclonal antibody in cell culture broth, about 18 - 50L fluid can be treated in a single cycle. MAb purification from lab scale (400mg per cycle) to a small pilot scale (2g per cycle) has been achieved. Compared with packed bed adsorption, the preparation cycle was half shortened, and the cost of production and the complexity of process were decreased markedly. It has been proven that a purification process based on expended bed adsorption technique is simple, efficient and economical.
通过连续灌注培养生产的单克隆抗体，采用扩张床吸附色谱法进行回收和纯化。使用填充床柱XK16/20与Streamline SP吸附剂进行方法探索。分别使用两根扩张床柱Streamline-25和-50进行方法优化和中试规模实验。单克隆抗体的回收率在纯度提高5至7倍、浓度提高10倍的情况下高于90%。根据细胞培养液中单克隆抗体的不同浓度，单个循环可处理约18至50L液体。已实现从实验室规模（每循环400mg）到小试规模（每循环2g）的单克隆抗体纯化。与填充床吸附相比，制备周期缩短了一半，生产成本和工艺复杂性显著降低。事实证明，基于扩张床吸附技术的纯化工艺简单、高效且经济。
