发明申请
- 专利标题： hGH AND METHODS FOR PREPARING hGH
- 专利标题（中）： hGH和制备hGH的方法
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申请号： US13029961申请日： 2011-02-17
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公开(公告)号： US20110237509A1公开(公告)日： 2011-09-29
- 发明人: Matthew M. Skinner , Ronald Zimmerman
- 申请人： Matthew M. Skinner , Ronald Zimmerman
- 申请人地址： US IN Greenwood
- 专利权人： Elona Biotechnologies
- 当前专利权人： Elona Biotechnologies
- 当前专利权人地址： US IN Greenwood
- 主分类号： A61K38/27
- IPC分类号： A61K38/27 ; C12N15/18 ; C07K14/61 ; C12N1/21 ; C12N15/63 ; A61P5/00
摘要：
Preparations of recombinant human growth hormone (hGH) are provided having a purity that comprises 2% or less of a peptide other than native human growth hormone (e.g., essentially free of multimeric forms) are disclosed. Active pharmaceutical ingredient (API) preparations of recombinant hGH suitable for commercial production of formulation grade recombinant hGH are provided. A stable Master Cell Bank of transformed E. coli is also disclosed, as well as methods for creating a transformed E. coli preparation that includes a Met-AsphGH encoding sequence. Improved manufacturing methods are also presented that are suitable for large scale production of highly purified preparations of recombinant human growth hormone.
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