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1.发明申请LIS-PRO PROINSULIN COMPOSITIONS AND METHODS OF PRODUCING LIS-PRO INSULIN ANALOGS THEREFROM 审中-公开LIS-PRO蛋白质组合物及其生产LIS-PRO胰岛素类似物的方法公开(公告)号：US20120214199A1
公开(公告)日：2012-08-23
申请号：US13032814
申请日：2011-02-23
CPC分类号： C07K14/62
摘要： Lis-Pro modified proinsulin sequences that have a modified C-peptide amino acid and/or nucleic acid modification are presented. Methods for producing Lis-Pro insulin analogs are also disclosed. Highly efficient processes for preparing the Lis-Pro insulin analogs and improved preparations containing the Lis-Pro insulin analogs prepared according to the methods described herein are also provided.
摘要翻译： 提出了具有修饰的C肽氨基酸和/或核酸修饰的Lis-Pro修饰的胰岛素原序列。 还公开了生产Lis-Pro胰岛素类似物的方法。 还提供了用于制备Lis-Pro胰岛素类似物的高效方法和根据本文所述方法制备的含有Lis-Pro胰岛素类似物的改进制剂。
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公开(公告)号：US20120214964A1
公开(公告)日：2012-08-23
申请号：US13032797
申请日：2011-02-23
摘要： Disclosed herein are novel and improved preparations and methods for manufacturing substantially liquid preparations of recombinant human insulin API. The purified recombinant human insulin Active Pharmaceutical Ingredient (API) preparations are substantially free of by-products associated with the lyophilization and/or crystallization. The methods for manufacturing the substantially liquid recombinant human insulin API preparations are provided with optional steps for subjecting the recombinant insulin preparation to lyophilization and/or crystallization. Enhanced yield of recombinant insulin of greater purity are thereby provided according to the present invention. Highly purified formulations of recombinant human insulin of the API insulin preparations disclosed herein are also provided. Stably transformed E. coli cell banks (WCB) capable of expressing the recombinant human insulin are also provided.
摘要翻译： 本文公开了用于制造重组人胰岛素API的基本液体制剂的新颖且改进的制剂和方法。 纯化的重组人胰岛素活性药物成分（API）制剂基本上不含与冻干和/或结晶相关的副产物。 制备基本上液体的重组人胰岛素API制剂的方法具有使重组胰岛素制剂进行冻干和/或结晶的任选步骤。 因此根据本发明提供了更高纯度的重组胰岛素的增加的产率。 还提供了本文公开的API胰岛素制剂的重组人胰岛素的高度纯化的制剂。 还提供了能够表达重组人胰岛素的稳定转化的大肠杆菌细胞库（WCB）。
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公开(公告)号：US20140213756A1
公开(公告)日：2014-07-31
申请号：US13750276
申请日：2013-01-25
IPC分类号： C07K14/62
摘要： Disclosed herein are novel and improved preparations and methods for manufacturing substantially liquid preparations of recombinant human insulin API. The purified recombinant human insulin Active Pharmaceutical Ingredient (API) preparations are substantially free of by-products associated with the lyophilization and/or crystallization. The methods for manufacturing the substantially liquid recombinant human insulin API preparations are provided with optional steps for subjecting the recombinant insulin preparation to lyophilization and/or crystallization. Enhanced yield of recombinant insulin of greater purity are thereby provided according to the present invention. Highly purified formulations of recombinant human insulin of the API insulin preparations disclosed herein are also provided. Stably transformed E. coli cell banks (WCB) capable of expressing the recombinant human insulin are also provided
摘要翻译： 本文公开了用于制造重组人胰岛素API的基本液体制剂的新颖且改进的制剂和方法。 纯化的重组人胰岛素活性药物成分（API）制剂基本上不含与冻干和/或结晶相关的副产物。 制备基本上液体的重组人胰岛素API制剂的方法具有使重组胰岛素制剂进行冻干和/或结晶的任选步骤。 因此根据本发明提供了更高纯度的重组胰岛素的增加的产率。 还提供了本文公开的API胰岛素制剂的重组人胰岛素的高度纯化的制剂。 还提供了能够表达重组人胰岛素的稳定转化的大肠杆菌细胞库（WCB）
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4.发明申请ASPART PROINSULIN COMPOSITIONS AND METHODS OF PRODUCING ASPART INSULIN ANALOGS THEREFROM 审中-公开ASPART蛋白质组合物及其生产ASPART胰岛素模拟物的方法公开(公告)号：US20120214963A1
公开(公告)日：2012-08-23
申请号：US13032775
申请日：2011-02-23
摘要： Aspart modified proinsulin sequences that have a modified C-peptide amino acid and/or nucleic acid modification for producing aspart insulin analogs are provided. Highly efficient processes for preparing the aspart insulin analogs and improved preparations containing the aspart insulin analogs prepared according to the methods described herein are also provided.
摘要翻译： 提供了具有修饰的C肽氨基酸和/或核酸修饰用于产生天冬氨酸胰岛素类似物的Aspart修饰的胰岛素原序列。 还提供了用于制备天冬氨酸胰岛素类似物的高效方法和根据本文所述方法制备的含有天冬氨酸胰岛素类似物的改进制剂。
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5.发明申请Aspart Proinsulin Compositions and Methods of Producing Aspart Insulin Analogs 审中-公开天冬氨酸胰岛素组合物和产生Aspart胰岛素类似物的方法公开(公告)号：US20140221606A1
公开(公告)日：2014-08-07
申请号：US13740794
申请日：2013-01-14
IPC分类号： C07K14/62
摘要： Aspart modified proinsulin sequences that have a modified C-peptide amino acid and/or nucleic acid modification for producing aspart insulin analogs are provided. Highly efficient processes for preparing the aspart insulin analogs and improved preparations containing the aspart insulin analogs prepared according to the methods described herein are also provided.
摘要翻译： 提供了具有修饰的C肽氨基酸和/或核酸修饰用于产生天冬氨酸胰岛素类似物的Aspart修饰的胰岛素原序列。 还提供了用于制备天冬氨酸胰岛素类似物的高效方法和根据本文所述方法制备的含有天冬氨酸胰岛素类似物的改进制剂。
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公开(公告)号：US20140213514A1
公开(公告)日：2014-07-31
申请号：US13750273
申请日：2013-01-25
CPC分类号： C07K14/62 , A61K38/28 , C12P21/02 , C12P21/06 , Y02A50/473
摘要： Novel pro-insulin having specific amino acid and/or nucleic acid modifications suitable for improved methods of insulin production are provided. Novel and highly efficient processes for preparing the pro-insulin preparations and preparations containing them are also disclosed. The novel pro-insulin preparations may be converted into human insulin useful in therapeutic preparations. Novel peptides of the C-peptide, and N terminus, including RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR, and MHHHHHHGGR respectively are provided, as well as the unique nucleic acid molecules encoding them.
摘要翻译： 提供了具有适于改进胰岛素生产方法的特异性氨基酸和/或核酸修饰的新型胰岛素。 还公开了制备前胰岛素制剂和含有它们的制剂的新颖和高效的方法。 胰岛素前体制剂可以转化为可用于治疗制剂的人胰岛素。 提供C肽和N末端的新肽，包括RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR和MHHHHHHGGR，以及编码它们的唯一核酸分子。
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7.发明申请GLARGINE PROINSULIN AND METHODS OF PRODUCING GLARGINE INSULIN ANALOGS THEREFROM 审中-公开GLARGIN PROINSULIN及其生产GLARGINE胰岛素类似物的方法公开(公告)号：US20120214965A1
公开(公告)日：2012-08-23
申请号：US13032806
申请日：2011-02-23
CPC分类号： C07K14/62 , C07K2319/21
摘要： Glargine proinsulin sconstructs that have a modified C-peptide amino acid and/or nucleic acid sequence for producing glargine insulin analogs are provided. Highly efficient processes for preparing the glargine insulin analogs and improved preparations containing the glargine insulin analogs prepared according to the methods described herein are also provided.
摘要翻译： 提供了具有用于产生甘精胰岛素类似物的修饰的C-肽氨基酸和/或核酸序列的甘精胰岛素原蛋白结构。 还提供了用于制备甘精胰岛素类似物的高效方法和根据本文所述方法制备的含有甘精胰岛素类似物的改良制剂。
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公开(公告)号：US20110237509A1
公开(公告)日：2011-09-29
申请号：US13029961
申请日：2011-02-17
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.
摘要翻译： 提供重组人生长激素（hGH）的制备，所述重组人生长激素（hGH）的纯度包括比天然人生长激素（例如，基本上不含多聚体形式）2％或更少的肽。 提供了适用于制剂级重组hGH的商业生产的重组hGH的活性药物成分（API）制剂。 还公开了转化的大肠杆菌的稳定的主细胞库，以及用于产生包含Met-AsphGH编码序列的转化的大肠杆菌制剂的方法。 还提出了适用于大规模生产重组人生长激素高度纯化制剂的改进的制备方法。
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公开(公告)号：US07790677B2
公开(公告)日：2010-09-07
申请号：US11725731
申请日：2007-03-20
CPC分类号： C07K14/62 , A61K38/28 , C12P21/02 , C12P21/06 , Y02A50/473
摘要： Novel pro-insulin having specific amino acid and/or nucleic acid modifications suitable for improved methods of insulin production are provided. Novel and highly efficient processes for preparing the pro-insulin preparations and preparations containing them are also disclosed. The novel pro-insulin preparations may be converted into human insulin useful in therapeutic preparations. Novel peptides of the C-peptide, and N terminus, including RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR (SEQ ID NO: 32), and MHHHHHHGGR (SEQ ID NO: 2) respectively are provided, as well as the unique nucleic acid molecules encoding them.
摘要翻译： 提供了具有适于改进胰岛素生产方法的特异性氨基酸和/或核酸修饰的新型胰岛素。 还公开了制备前胰岛素制剂和含有它们的制剂的新颖和高效的方法。 胰岛素前体制剂可以转化为可用于治疗制剂的人胰岛素。 提供C-肽和N末端的新肽，分别包括RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR（SEQ ID NO：32）和MHHHHHHGG（SEQ ID NO：2），以及编码它们的唯一核酸分子。
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公开(公告)号：US20100210815A1
公开(公告)日：2010-08-19
申请号：US12658852
申请日：2010-02-16
CPC分类号： C07K14/62 , A61K38/28 , C12P21/02 , C12P21/06 , Y02A50/473
摘要： Novel pro-insulin having specific amino acid and/or nucleic acid modifications suitable for improved methods of insulin production are provided. Novel and highly efficient processes for preparing the pro-insulin preparations and preparations containing them are also disclosed. The novel pro-insulin preparations may be converted into human insulin useful in therapeutic preparations. Novel peptides of the C-peptide, and N terminus, including RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR (SEQ ID NO:32), and MHHHHHHGGR (SEQ ID NO:36) respectively are provided, as well as the unique nucleic acid molecules encoding them.
摘要翻译： 提供了具有适于改进胰岛素生产方法的特异性氨基酸和/或核酸修饰的新型胰岛素。 还公开了制备前胰岛素制剂和含有它们的制剂的新颖和高效的方法。 胰岛素前体制剂可以转化为可用于治疗制剂的人胰岛素。 提供C-肽和N末端的新肽，分别包括RREAEALQVGQVELGGGPGAGSLQPLALEGSLQAR（SEQ ID NO：32）和MHHHHHHGG（SEQ ID NO：36），以及编码它们的唯一核酸分子。
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