大规模提取体内治疗用单克隆抗体的工艺

用两步法从WuT3细胞培养上清中提取WuT3单克隆抗体（McAb），首先将培养上清直接上SP离子交换柱，再上DEAE柱，获取提纯的McAb。该工艺的确定及放大均在Pharmacia产Biopilot中试纯化系统上进行。一次投料20L，纯化规模达2g，纯化的McAb经SDS－PAGE测定，纯度基本达到95％，免疫荧光活性为66±9％。热原质合格，支原体、残余DNA均为阴性，达到体内制剂质控要求。

Large-scale Purification Process of Therapeutic McAb

WuT3 McAb was extracted from culture supernatant by SP-Sepharose cationexchange chrometograhy, then purified by DEAE-52 anion-exchange chromatography. Theprocess was established and scaled-up using a BioPilot system(Pharmacia). 20L of materialscould be put at one time,and 2g of McAbs could be purified. The purity of the McAb detected by SDS-PAGE reached 95%,and the immunoactivity of it detected by immunofluorescencewas 66±9%. The McAb passed pyrogen test,and no mycoplasma or residual DNA was detected out in it. It proved that the McAb reached the standard for the quality control of therapeutic drug in vivo.