公开(公告)号：EP3116531A1

公开(公告)日：2017-01-18

申请号：EP15761797.8

申请日：2015-03-11

申请人： Merck Sharp & Dohme Corp.

发明人： ORTIGOSA, Allison, D. ,  COLEMAN, Michael, P. ,  GEORGE, Shibu, T. ,  RAUSCHER, Michael, A. ,  SLEEVI, Mark, C. ,  CHOW, Kartoa

IPC分类号： A61K38/28 ,  A61K38/00 ,  C07K1/00

CPC分类号： C07K14/62 ,  C07K1/18 ,  C07K1/20

摘要： A process is described for purifying insulin and insulin analogs that comprises high-pressure liquid chromatography with an acidic cation exchange medium performed in the presence of a water miscible organic modifier and at an elevated temperature followed by reverse phase chromatography performed in the presence of a water miscible organic modifier and at an elevated temperature.

摘要翻译： 一种方法是在在升高的温度，然后在水的存在下进行反相色谱法在水混溶性有机改性剂的存在下和在执行的酸性阳离子交换介质描述了用于纯化胰岛素和胰岛素类似物也包括高压液相色谱法，用 混溶的有机改性剂和在升高的温度。

公开(公告)号：EP3268384A1

公开(公告)日：2018-01-17

申请号：EP16762165.5

申请日：2016-03-03

申请人： Merck Sharp & Dohme Corp.

发明人： GANT, Sean, S. ,  IAMMARINO, Michael, J. ,  KERCHNER, Kristi ,  RAUSCHER, Michael, A. ,  ROUSH, David, J. ,  SMITH, Christopher, H. ,  CHANDLER, Martin ,  PETROFF, Matthew

IPC分类号： C07K14/62 ,  C12N9/50 ,  C12N15/09 ,  C12P21/00 ,  C12P21/06

CPC分类号： C07K14/62 ,  C07K1/34 ,  C12P21/06

摘要： The use of two tandem microfiltration (MF) steps in a process for making recombinant insulin is described. The two MF steps in a single downstream purification unit operation reduce both soluble and insoluble impurities and exchange the insulin product into a suitable buffer for downstream purification.

公开(公告)号：EP3171888A1

公开(公告)日：2017-05-31

申请号：EP15824392.3

申请日：2015-07-16

申请人： Merck Sharp & Dohme Corp.

发明人： WATSON, Douglas, S. ,  ORTIGOSA, Allison, D. ,  RAUSCHER, Michael, A. ,  STORY, Kathryn, M.

IPC分类号： A61K38/28 ,  C07K14/62

CPC分类号： C07K14/62 ,  B01D15/1878 ,  B01D15/327 ,  B01D15/363 ,  B01D15/3847 ,  C07K1/18 ,  C07K1/20

摘要： A process is described for purifying insulin and insulin analogs that comprises use of two or more orthogonal chromatographic purification steps in tandem following enzymatic digestion of the propeptide-insulin precursor to remove specific product impurities, improve process consistency, and increase process redundancy in the purification of the insulin or insulin analog, e.g., insulin lispro.

摘要翻译： 描述了用于纯化胰岛素和胰岛素类似物的方法，其包括在前肽 - 胰岛素前体的酶促消化之后串联使用两个或更多个正交色谱纯化步骤以去除特定产物杂质，提高过程一致性并增加纯化 胰岛素或胰岛素类似物，例如赖脯胰岛素。