重组人尿型纤溶酶原激活剂的中试生产与性质研究

Characterization and Pilot Production of Recombinant Human Urinary-type Plasminogen Activator

表达u PA的CHO dhfr 工程细胞CL 1 1G在 30升生物反应器中高密度大规模培养 65天后 ,获得 1 2 0 0余升细胞培养上清 ;经阳离子交换层析、凝胶过滤、苯甲眯亲和层析和阴离子交换层析四步纯化工艺 ,获得u PA冻干纯品 40克。对产品进行性质研究和质量检定 ,各项指标符合理论数据和《中国生物制品规程》。

A CHO-dhfr-engineering cell line CL-11G,which expresses recombinant human urinary-type plasminogen activator (u-PA),was cultivated by high density and large-scale in a 30L bioreactor.By purification with cation-exchange chromatography,gel-filtration,Benzamindin affinity chromatography and anion-exchange chromatography,40g u-PA lyophilized product was obtained from 1200 liters supernatant.All the assay contents of u-PA product were consistent with theoretical data and ‘Chinese Biologicals Requirements'.;