- 专利标题: Chromatography process for purification of insulin and insulin analogs
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申请号: US15327096申请日: 2015-07-16
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公开(公告)号: US10155799B2公开(公告)日: 2018-12-18
- 发明人: Douglas S. Watson , Allison D. Ortigosa , Michael A. Rauscher , Kathryn M. Story
- 申请人: Merck Sharp & Dohme Corp.
- 申请人地址: US NJ Rahway
- 专利权人: Merck Sharp & Dohme Corp.
- 当前专利权人: Merck Sharp & Dohme Corp.
- 当前专利权人地址: US NJ Rahway
- 代理商 John David Reilly; Laura M. Ginkel
- 国际申请: PCT/US2015/040675 WO 20150716
- 国际公布: WO2016/014325 WO 20160128
- 主分类号: B01D15/18
- 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.