摘要
从重组IL-2菌株发酵后包含体中,采用增溶分离、分子筛层析、超滤和反相HPLC等工艺,纯化出具备临床质量要求的IL-2.全套工艺在10d内完成,每周期可获IL-2达200mg(8×10~8CU),产品比活为4×1O^6CU/mg蛋白,回收率为37.5%,产品纯度为99%.产品经家兔热原试验、小鼠安全试验和内毒素测定符合临床要求.根据本实验室规模每周期具备放大5～10倍的能力.
Recombinant human interleukin-2 (rIL-2) produced from inclusion bodies in E. coli was purified to apparent homogeneity of clinic-standard by solubilization separation, gel-filtration chromatog-raphy, ultra-filtration, reverse-phase high performance liquid chromatography. The whole process was completed within 10 days, and rIL-2 was obtained about 200 mg (8×108 CU) for each cycle; and the specific activity was about 4× 106 CU/mg pro, yield 37. 5% and purity 99%. The product was examined of rabbit-pyrogen test, mouse safety test and endotoxin test; and the results reached clinic level. This production capacity can be amplified to 5-10 folds.
