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1. 发明授权

US06489450B2 High pressure refolding of protein aggregates and inclusion bodies 有权
标题翻译：蛋白质聚集体和包涵体的高压重折叠
公开(公告)号：US06489450B2
公开(公告)日：2002-12-03
申请号：US09350327
申请日：1999-07-09
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John
IPC分类号： A23J100
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.
摘要翻译：本公开提供了在溶液中重折叠变性蛋白质的有效方法，从而以高产率回收溶液中适当折叠的生物活性蛋白质。重折叠在约0.25kbar至约3.5kbar之间，有利地为约1.5kbar至约3kbar的压力下进行。通常，离液剂以对大气压下变性蛋白质无效的浓度存在，并且任选地，氧化还原试剂可以并入再折叠溶液中，使得可以在需要的地方形成天然的分子内二硫键。该方法适用于基本上所有蛋白质，特别是在溶解和/或变性不溶性蛋白质聚集体，包涵体或异常低聚（可溶））聚集体之后。

2. 发明申请

US20080161242A1 High pressure treatment of proteins for reduced immunogenicity 审中-公开
标题翻译：高压处理蛋白质降低免疫原性
公开(公告)号：US20080161242A1
公开(公告)日：2008-07-03
申请号：US11901613
申请日：2007-09-17
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John , Lyndal K. Hesterberg , Matthew B. Seefeldt
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John , Lyndal K. Hesterberg , Matthew B. Seefeldt
IPC分类号： A61K38/00
CPC分类号： C07K1/1136 , A61K38/1774 , A61K38/215 , A61K38/27
摘要： Protein compositions with reduced immunogenicity are disclosed, as well as methods for producing such compositions.
摘要翻译：公开了具有降低的免疫原性的蛋白质组合物，以及生产这种组合物的方法。

3. 发明授权

US07064192B2 High pressure refolding of protein aggregates and inclusion bodies 有权
公开(公告)号：US07064192B2
公开(公告)日：2006-06-20
申请号：US10292692
申请日：2002-11-12
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John
IPC分类号： C07K1/02 , C12N9/00
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.

4. 发明授权

US07767795B2 High pressure refolding of protein aggregates and inclusion bodies 有权
标题翻译：蛋白质聚集体和包涵体的高压重折叠
公开(公告)号：US07767795B2
公开(公告)日：2010-08-03
申请号：US11341013
申请日：2006-01-27
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John
IPC分类号： C07K14/00 , C12N9/00
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.
摘要翻译：本公开提供了在溶液中重折叠变性蛋白质的有效方法，从而以高产率回收溶液中适当折叠的生物活性蛋白质。重折叠在约0.25kbar至约3.5kbar之间，有利地为约1.5kbar至约3kbar的压力下进行。通常，离液剂以对大气压下变性蛋白质无效的浓度存在，并且任选地，氧化还原试剂可以并入再折叠溶液中，使得可以在需要的地方形成天然的分子内二硫键。该方法适用于基本上所有蛋白质，特别是在溶解和/或变性不溶性蛋白质聚集体，包涵体或异常低聚（可溶））聚集体之后。

5. 发明授权

US08710197B2 High pressure refolding of protein aggregates and inclusion bodies 失效
标题翻译：蛋白质聚集体和包涵体的高压重折叠
公开(公告)号：US08710197B2
公开(公告)日：2014-04-29
申请号：US12940587
申请日：2010-11-05
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John
IPC分类号： C07K14/00 , C12N9/00
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.
摘要翻译：本公开提供了在溶液中重折叠变性蛋白质的有效方法，从而以高产率回收溶液中适当折叠的生物活性蛋白质。重折叠在约0.25kbar至约3.5kbar之间，有利地为约1.5kbar至约3kbar的压力下进行。通常，离液剂以对大气压下变性蛋白质无效的浓度存在，并且任选地，氧化还原试剂可以并入再折叠溶液中，使得可以在需要的地方形成天然的分子内二硫键。该方法适用于基本上所有蛋白质，特别是在溶解和/或变性不溶性蛋白质聚集体，包涵体或异常低聚（可溶））聚集体之后。

6. 发明申请

US20110046357A1 HIGH PRESSURE REFOLDING OF PROTEIN AGGREGATES AND INCLUSION BODIES 失效
标题翻译：蛋白质聚集体和包涵体的高压重塑
公开(公告)号：US20110046357A1
公开(公告)日：2011-02-24
申请号：US12940587
申请日：2010-11-05
申请人： Theodore W. Randolph , John F. Carpenter , Richard St. John
发明人： Theodore W. Randolph , John F. Carpenter , Richard St. John
IPC分类号： C07K1/14
CPC分类号： C07K14/61 , C07K1/1133 , C07K1/1136 , C12N9/2462
摘要： The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.
摘要翻译：本公开提供了在溶液中重折叠变性蛋白质的有效方法，从而以高产率回收溶液中适当折叠的生物活性蛋白质。重折叠在约0.25kbar至约3.5kbar之间，有利地为约1.5kbar至约3kbar的压力下进行。通常，离液剂以对大气压下变性蛋白质无效的浓度存在，并且任选地，氧化还原试剂可以并入再折叠溶液中，使得可以在需要的地方形成天然的分子内二硫键。该方法适用于基本上所有蛋白质，特别是在溶解和/或变性不溶性蛋白质聚集体，包涵体或异常低聚（可溶））聚集体之后。

7. 发明申请

US20110243996A1 Spray freeze dry of compositions for intranasal administration 审中-公开
标题翻译：用于鼻内给药的组合物喷雾冷冻干燥
公开(公告)号：US20110243996A1
公开(公告)日：2011-10-06
申请号：US13065965
申请日：2011-04-01
申请人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
发明人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
IPC分类号： A61K35/76 , A61K9/14
CPC分类号： A61K9/0043 , A61K9/1617 , A61K9/1623 , A61K9/1658 , A61K9/1694
摘要： This invention provides methods and compositions to preserve bioactive materials, such as peptides, nucleic acids, viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for intranasal administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles for intranasal administration.
摘要翻译：本发明提供在适于鼻内给药的冷冻干燥颗粒中保存生物活性物质如肽，核酸，病毒，细菌，细胞或脂质体的方法和组合物。方法提供制剂的喷雾冷冻干燥以形成用于鼻内给药的稳定的冷冻干燥颗粒。

8. 发明申请

US20100330162A1 Spray freeze dry of compositions for pulmonary adminstration 失效
标题翻译：用于肺部给药的组合物喷雾冷冻干燥
公开(公告)号：US20100330162A1
公开(公告)日：2010-12-30
申请号：US12807343
申请日：2010-09-01
申请人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
发明人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
IPC分类号： A61K9/127 , A61K39/145 , A61K9/14 , A61P31/12 , A61P31/04
CPC分类号： A61K9/0075 , A01N1/02 , A01N1/0252 , A61K9/1694 , A61K9/19
摘要： This invention provides methods and compositions to preserve bioactive materials, such as viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for pulmonary administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles.
摘要翻译：本发明提供了在适于肺部给药的冷冻干燥颗粒中保存生物活性物质如病毒，细菌，细胞或脂质体的方法和组合物。方法提供喷雾冷冻干燥制剂以形成稳定的冻干颗粒。

9. 发明授权

US07923029B2 Spray freeze dry of compositions for pulmonary administration 有权
标题翻译：用于肺部给药的组合物喷雾冷冻干燥
公开(公告)号：US07923029B2
公开(公告)日：2011-04-12
申请号：US10412644
申请日：2003-04-10
申请人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
发明人： Vu Truong-Le , Binh V. Pham , John F. Carpenter , Robert Seid , Theodore W. Randolph
IPC分类号： A61K9/14 , A61K9/19
CPC分类号： A61K9/0075 , A01N1/02 , A01N1/0252 , A61K9/1694 , A61K9/19
摘要： This invention provides methods and compositions to preserve bioactive materials, such as viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for pulmonary administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles.
摘要翻译：本发明提供了在适于肺部施用的冷冻干燥颗粒中保存生物活性物质如病毒，细菌，细胞或脂质体的方法和组合物。方法提供喷雾冷冻干燥制剂以形成稳定的冻干颗粒。

10. 发明授权

US08444991B2 Method of preparing an immunologically-active adjuvant-bound dried vaccine composition 有权
标题翻译：制备免疫活性佐剂结合的干燥疫苗组合物的方法
公开(公告)号：US08444991B2
公开(公告)日：2013-05-21
申请号：US12532225
申请日：2008-03-18
申请人： Theodore W. Randolph , Amber Clausi , John F. Carpenter , Daniel K. Schwartz
发明人： Theodore W. Randolph , Amber Clausi , John F. Carpenter , Daniel K. Schwartz
IPC分类号： A61K39/00 , A61K39/02 , A61K39/08
CPC分类号： A61K47/48015 , A61K9/19 , A61K39/08 , A61K2039/55505 , A61K2039/55511 , A61K2039/60 , A61K2039/622 , Y02A50/469
摘要： The disclosure provides a method of preparing an immunologically-active adjuvant-bound freeze dried vaccine composition. A specific embodiment provides a stable vaccine composition comprising an aluminum-salt adjuvant, a recombinant Clostridium botulinum neurotoxin protein and a glass-forming agent. These vaccine compositions are useful in the treatment of humans and other animals at risk of infection from Clostridium botulinum neurotoxin.
摘要翻译：本公开提供了制备免疫学活性佐剂结合的冷冻干燥疫苗组合物的方法。具体实施方案提供了包含铝盐佐剂，重组肉毒杆菌神经毒素蛋白质和玻璃形成剂的稳定的疫苗组合物。这些疫苗组合物可用于治疗肉毒杆菌神经毒素感染风险的人和其他动物。

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