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1. 发明申请

US20120114646A1 LYOPHILIZED FORMULATIONS FOR SMALL MODULAR IMMUNOPHARMACEUTICALS 审中-公开
标题翻译：用于小型模块化免疫球蛋白的LYOPHILIZED制剂
公开(公告)号：US20120114646A1
公开(公告)日：2012-05-10
申请号：US13378751
申请日：2010-06-18
申请人： Serguei Tchessalov , Angela Kantor , Li Li , Nicholas Luksha , Nicholas Warne
发明人： Serguei Tchessalov , Angela Kantor , Li Li , Nicholas Luksha , Nicholas Warne
IPC分类号： A61K39/395 , A61P37/00
CPC分类号： A61K39/39591 , A61K9/0014 , A61K9/19 , A61K47/183 , A61K47/26 , C07K16/2887 , C07K2317/24 , C07K2317/52 , C07K2317/56 , C07K2317/622 , C07K2319/00
摘要： The present invention provides, among other things, stable formulations for small modular immunopharmaceutical (SMIP™) proteins. In some embodiments, the present invention provides a formulation containing a lyophilized mixture of a small modular immunopharmaceutical protein, wherein less than 7% of the lyophilized small modular immunopharmaceutical protein exists in aggregated form. Formulations according to the invention may contain buffering agents, stabilizers, bulking agents, surfactants and/or other excipients. The present invention also provides formulations for lyophilization, reconstitution and methods of use thereof.
摘要翻译：本发明尤其提供了用于小型模块化免疫药物（SMIP TM）蛋白质的稳定制剂。在一些实施方案中，本发明提供含有小模块化免疫药物蛋白质的冻干混合物的制剂，其中小于7％的冻干小模块化免疫药物蛋白以聚集形式存在。根据本发明的制剂可以含有缓冲剂，稳定剂，填充剂，表面活性剂和/或其它赋形剂。本发明还提供了用于冻干，重构和其使用方法的制剂。

2. 发明授权

US09884019B2 Lyophilization above collapse 有权
公开(公告)号：US09884019B2
公开(公告)日：2018-02-06
申请号：US12536321
申请日：2009-08-05
申请人： Serguei Tchessalov , Dan Dixon , Nicholas Warne
发明人： Serguei Tchessalov , Dan Dixon , Nicholas Warne
IPC分类号： A61K9/19 , A61K38/00 , A61K38/22 , A61K38/43 , A61K39/00 , A61K39/395 , A61K47/02 , A61K47/10 , A61K47/26 , A61K39/12 , A61K47/18
CPC分类号： A61K9/19
摘要： The present invention provides methods of lyophilizing a pharmaceutical substance involving a primary drying step executed at a product temperature at or above the collapse temperature. The invention also provides pharmaceutical substances lyophilized at or above the collapse temperature.

3. 发明申请

US20090324586A1 LYOPHILIZATION CYCLE ROBUSTNESS STRATEGY 审中-公开
标题翻译： LYOPHILIZATION CYCLE ROBUSTNESS策略
公开(公告)号：US20090324586A1
公开(公告)日：2009-12-31
申请号：US12492052
申请日：2009-06-25
申请人： Serguei Tchessalov , Daniel Dixon , Anthony Barry , Nicholas Warne
发明人： Serguei Tchessalov , Daniel Dixon , Anthony Barry , Nicholas Warne
IPC分类号： A61K39/395 , F26B5/06 , G01N33/48 , A61K38/16 , A61K38/43
CPC分类号： F26B5/06
摘要： The present invention provides methods for assessing and optimizing lyophilization cycle robustness. In particular, the present invention provides rapid assessment of cycle robustness with respect to a variety of lyophilization process deviations by varying a relatively small number of parameters.
摘要翻译：本发明提供了评估和优化冻干循环鲁棒性的方法。特别地，本发明通过改变相对较少数量的参数来提供关于各种冻干过程偏差的循环鲁棒性的快速评估。

4. 发明申请

US20080098614A1 Lyophilization methods and apparatuses 审中-公开
标题翻译：冻干方法和装置
公开(公告)号：US20080098614A1
公开(公告)日：2008-05-01
申请号：US11906622
申请日：2007-10-03
申请人： Serguei Tchessalov , Nicholas Warne
发明人： Serguei Tchessalov , Nicholas Warne
IPC分类号： F26B5/06 , F26B19/00
CPC分类号： F26B5/06
摘要： A method and apparatus for optimizing the primary drying step of a lyophilization cycle of a biological or pharmaceutical material. In one aspect, the invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a product temperature profile for the material and modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step. In another aspect, the invention is an apparatus for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium, a processor in electrical communication with the computer-readable medium, a chamber pressure module in electrical communication with the processor, and a shelf temperature module in electrical communication with the processor.
摘要翻译：一种用于优化生物或药物材料的冻干循环的初级干燥步骤的方法和装置。一方面，本发明是一种用于冻干材料的方法，包括以下步骤：基于材料的产品温度分布计算材料的设计的初级干燥循环，并根据设计的主要原料改变室压力和搁板温度一次干燥步骤中的干燥循环。另一方面，本发明是一种用于根据设计的初级干燥循环对材料进行冻干的装置，包括计算机可读介质，与计算机可读介质电连通的处理器，与处理器电通信的室压模块，以及与处理器电连通的搁架温度模块。

5. 发明申请

US20100041870A1 LYOPHILIZATION ABOVE COLLAPSE 有权
标题翻译：在上述的收集
公开(公告)号：US20100041870A1
公开(公告)日：2010-02-18
申请号：US12536321
申请日：2009-08-05
申请人： Serguei Tchessalov , Dan Dixon , Nicholas Warne
发明人： Serguei Tchessalov , Dan Dixon , Nicholas Warne
IPC分类号： C07K14/00 , C08B37/00 , C07H1/00 , F26B5/06
CPC分类号： A61K9/19
摘要： The present invention provides methods of lyophilizing a pharmaceutical substance involving a primary drying step executed at a product temperature at or above the collapse temperature. The invention also provides pharmaceutical substances lyophilized at or above the collapse temperature.
摘要翻译：本发明提供冻干包含在塌陷温度以上的产品温度下执行的初级干燥步骤的药物的方法。本发明还提供了在崩溃温度或高于塌陷温度下冻干的药物物质。

6. 发明授权

US07087723B2 Albumin-free factor VIII formulations 有权
标题翻译：无白蛋白因子VIII配方
公开(公告)号：US07087723B2
公开(公告)日：2006-08-08
申请号：US10610723
申请日：2003-07-01
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K35/14 , A61K38/16
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
摘要翻译：不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。

7. 发明申请

US20080176791A1 NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS 有权
标题翻译：新型无氨基因因子VIII配方
公开(公告)号：US20080176791A1
公开(公告)日：2008-07-24
申请号：US11764770
申请日：2007-06-18
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K38/37
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
摘要翻译：不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。

8. 发明授权

US07247707B2 Albumin-free factor VIII formulations 有权
标题翻译：无白蛋白因子VIII配方
公开(公告)号：US07247707B2
公开(公告)日：2007-07-24
申请号：US11434634
申请日：2006-05-15
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K35/14 , A61K38/16
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
摘要翻译：不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。

9. 发明授权

US08058226B2 Albumin-free factor VIII formulations 有权
标题翻译：无白蛋白因子VIII配方
公开(公告)号：US08058226B2
公开(公告)日：2011-11-15
申请号：US11764770
申请日：2007-06-18
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K35/14 , A61K38/16 , A61K39/00 , A61K51/00
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
摘要翻译：不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。

10. 发明申请

US20060205661A1 Novel albumin-free factor VIII formulations 有权
标题翻译：新型无白蛋白因子VIII配方
公开(公告)号：US20060205661A1
公开(公告)日：2006-09-14
申请号：US11434634
申请日：2006-05-15
申请人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
发明人： Marc Besman , Erik Bjornson , Feroz Jameel , Ramesh Kashi , Michael Pikal , Serguei Tchessalov , John Carpenter
IPC分类号： A61K38/36 , A61K38/37
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/26 , A61K47/38 , Y10S514/834 , Y10S530/829
摘要： A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
摘要翻译：不含白蛋白的因子VIII组合物，除了因子VIII外还包含以下制剂赋形剂：4％至10％的选自甘露醇，甘氨酸和丙氨酸的填充剂; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。或者，制剂可以包含2％至6％的羟乙基淀粉; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 100mM至300mM NaCl; 以及用于保持约6至8的pH的缓冲剂。在另一个实施方案中，制剂可以包含：300mM至500mM NaCl; 1％至4％的选自蔗糖，海藻糖，棉子糖和精氨酸的稳定剂; 1mM至5mM钙盐; 和缓冲剂。

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