公开(公告)号：US10124040B2

公开(公告)日：2018-11-13

申请号：US15505124

申请日：2015-08-21

申请人： Merck Sharp & Dohme Corp. ,  Douglas S. Watson ,  Allison C. Ortigosa ,  Mark C. Sleevi ,  Kathryn M. Story

发明人： Douglas S. Watson ,  Allison C. Ortigosa ,  Mark C. Sleevi ,  Kathryn M. Story

IPC分类号： A61K38/28 ,  A61K47/02 ,  A61K47/10 ,  A61K9/14 ,  C07K14/62

摘要： A method for crystallizing insulin or insulin analogs under alkaline conditions in the presence of zinc, purifying the crystals by filtering through a filter, and drying the crystals captured on the filter to produce crystalline insulin or insulin analog compositions is described. Method has been exemplified with insulin lispro.

公开(公告)号：US20170209545A1

公开(公告)日：2017-07-27

申请号：US15505124

申请日：2015-08-21

申请人： Douglas S. WATSON ,  Allison C. ORTIGOSA ,  Mark C. SLEEVI ,  Kathryn M. STORY ,  Merck Sharp & Dohme Corp.

发明人： Douglas S. Watson ,  Allison C. Ortigosa ,  Mark C. Sleevi ,  Kathryn M. Story

IPC分类号： A61K38/28 ,  A61K47/10 ,  A61K9/14 ,  A61K47/02

CPC分类号： A61K38/28 ,  A61K9/143 ,  A61K9/145 ,  A61K47/02 ,  A61K47/10 ,  C07K14/62

摘要： A method for crystallizing insulin or insulin analogs under alkaline conditions in the presence of zinc, purifying the crystals by filtering through a filter, and drying the crystals captured on the filter to produce crystalline insulin or insulin analog compositions is described. Method has been exemplified with insulin lispro.

公开(公告)号：US20170174737A1

公开(公告)日：2017-06-22

申请号：US15327096

申请日：2015-07-16

申请人： Douglas S. WATSON ,  Allison D. ORTIGOSA ,  Michael A. RAUSCHER ,  Kathryn M. STORY ,  Merck Sharp & Dohme Corp.

发明人： Douglas S. Watson ,  Allison D. Ortigosa ,  Michael A. Rauscher ,  Kathryn M. Story

IPC分类号： C07K14/62 ,  B01D15/36 ,  B01D15/32 ,  C07K1/18 ,  C07K1/20

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.

公开(公告)号：US10155799B2

公开(公告)日：2018-12-18

申请号：US15327096

申请日：2015-07-16

申请人： Merck Sharp & Dohme Corp.

发明人： Douglas S. Watson ,  Allison D. Ortigosa ,  Michael A. Rauscher ,  Kathryn M. Story

IPC分类号： B01D15/18 ,  C07K14/62 ,  B01D15/32 ,  B01D15/36 ,  C07K1/18 ,  C07K1/20 ,  B01D15/38

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.