公开(公告)号：EP3805257A1

公开(公告)日：2021-04-14

申请号：EP19808332.1

申请日：2019-05-23

申请人： Jiangsu Hengrui Medicine Co., Ltd.

发明人： ZHAO, Liangliang ,  HAN, Guangjie ,  NIU, Ningning ,  LI, Na ,  LIU, Yanwei ,  WANG, Hongwei

IPC分类号： C07K14/62 ,  C07K1/36 ,  C12P21/00

摘要： Disclosed is a method for preparing a precursor of a recombinant human insulin or an analogue thereof, comprising: a. bacterial fermentation, centrifuging a fermentation broth in a continuous flow to collect a supernatant; b. filtering the supernatant in step (a) by means of a hollow fiber membrane and collecting the filtrate; and c. purifying the filtrate in the step (b) by means of a chromatography column. The method has the advantages of streamlined steps, scalability, no use of organic solvents, high yield, etc. The purity of the insulin precursor can exceed 90%, the host cell protein removal rate exceeds 90%, and the exogenous DNA removal rate is 89% or greater, achieving less than 0.1 ng/mg.