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1. 发明申请

WO2010148337A1 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：WO2010148337A1
公开(公告)日：2010-12-23
申请号：PCT/US2010/039227
申请日：2010-06-18
申请人： WYETH LLC , TCHESSALOV, Serguei , KANTOR, Angela , LI, Li , LUKSHA, Nicholas , WARNE, Nicholas
发明人： TCHESSALOV, Serguei , KANTOR, Angela , LI, Li , LUKSHA, Nicholas , WARNE, Nicholas
IPC分类号： A61K9/19
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 TM ) 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（SMIPTM）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. 发明申请

WO2010017296A1 LYOPHILIZATION ABOVE COLLAPSE 审中-公开
标题翻译：在上述的收集
公开(公告)号：WO2010017296A1
公开(公告)日：2010-02-11
申请号：PCT/US2009/052852
申请日：2009-08-05
申请人： WYETH , TCHESSALOV, Serguei , DIXON, Dan , WARNE, Nicholas
发明人： TCHESSALOV, Serguei , DIXON, Dan , WARNE, Nicholas
IPC分类号： A61K9/19
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。

3. 发明申请

WO2009158529A3 LYOPHILIZATION CYCLE ROBUSTNESS STRATEGY 审中-公开
标题翻译： LYOPHILIZATION CYCLE ROBUSTNESS策略
公开(公告)号：WO2009158529A3
公开(公告)日：2010-09-30
申请号：PCT/US2009048708
申请日：2009-06-25
申请人： WYETH LLC , TCHESSALOV SERGUEI , DIXON DANIEL , BARRY ANTHONY , WARNE NICHOLAS
发明人： TCHESSALOV SERGUEI , DIXON DANIEL , BARRY ANTHONY , WARNE NICHOLAS
IPC分类号： F26B5/06
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

WO2010054238A1 FACTOR VIII FORMULATIONS 审中-公开
标题翻译：因素八制定
公开(公告)号：WO2010054238A1
公开(公告)日：2010-05-14
申请号：PCT/US2009/063610
申请日：2009-11-06
申请人： BAXTER INTERNATIONAL INC. , UNIVERSITY OF CONNECTICUT , PIKAL, Michael , TCHESSALOV, Serguei , BJORNSON, Erik , JAMEEL, Feroz , BESMAN, Marc
发明人： PIKAL, Michael , TCHESSALOV, Serguei , BJORNSON, Erik , JAMEEL, Feroz , BESMAN, Marc
IPC分类号： A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/20 , A61K47/26 , A61K9/00 , A61K38/37
CPC分类号： A61K38/37 , A61K9/0019 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/18 , A61K47/183 , A61K47/20 , A61K47/26
摘要： A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.
摘要翻译：配制的因子VIII（FVIII）组合物使得NaCl不存在于最终制剂中或以微量存在，这允许冻干周期时间的伴随减少和冻干FVIII的稳定性增加。

5. 发明申请

WO2009158529A8 LYOPHILIZATION CYCLE ROBUSTNESS STRATEGY 审中-公开
标题翻译：冻干循环鲁棒性策略
公开(公告)号：WO2009158529A8
公开(公告)日：2010-03-11
申请号：PCT/US2009048708
申请日：2009-06-25
申请人： WYETH LLC , TCHESSALOV SERGUEI , DIXON DANIEL , BARRY ANTHONY , WARNE NICHOLAS
发明人： TCHESSALOV SERGUEI , DIXON DANIEL , BARRY ANTHONY , WARNE NICHOLAS
IPC分类号： A61K39/395 , A61K38/16 , A61K38/43 , F26B5/06 , G01N33/48
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稳健性的方法。具体而言，本发明通过改变相对少量的参数来提供关于各种冻干过程偏差的周期稳健性的快速评估。

6. 发明申请

WO2008042408A3 LYOPHILIZATION METHODS AND APPARATUSES 审中-公开
标题翻译： LYOPHILIZATION方法和设备
公开(公告)号：WO2008042408A3
公开(公告)日：2008-11-27
申请号：PCT/US2007021240
申请日：2007-10-03
申请人： WYETH CORP , TCHESSALOV SERGUEI A , WARNE NICK
发明人： TCHESSALOV SERGUEI A , WARNE NICK
IPC分类号： F26B5/06
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 (10) for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium (12), a processor (14) in electrical communication with the computer-readable medium (12), a chamber pressure module (16) in electrical communication with the processor (14), and a shelf temperature module (18) in electrical communication with the processor (14).
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，本发明是用于冻干材料的方法，包括以下步骤：基于材料的产品温度prO文件计算材料的设计的主要干燥循环，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。在另一方面，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设备（10），包括计算机可读介质（12），与计算机可读介质（12）电连接的处理器（14），与所述处理器（14）电连通的腔室压力模块（16）以及与所述处理器（14）电连通的搁架温度模块（18）。

7. 发明申请

WO2010148321A1 SLOW DISSOLUTION METHOD FOR RECONSTITUTION OF LYOPHILIZED MATERIAL 审中-公开
标题翻译：慢解析方法，用于重新分析LYOPHILIZED材料
公开(公告)号：WO2010148321A1
公开(公告)日：2010-12-23
申请号：PCT/US2010/039205
申请日：2010-06-18
申请人： WYETH LLC , TCHESSALOV, Serguei , KANTOR, Angela , LI, Li , LUKSHA, Nicholas , WARNE, Nicholas
发明人： TCHESSALOV, Serguei , KANTOR, Angela , LI, Li , LUKSHA, Nicholas , WARNE, Nicholas
IPC分类号： A61K39/395
CPC分类号： C07K16/2887 , A61K9/0019 , A61K9/19 , A61K39/39591 , C07K2317/24 , C07K2317/52 , C07K2317/56
摘要： The present invention relates to robust, reproducible and convenient methods for reconstituting lyophilized substance. Among other things, the present invention provides methods for reconstituting lyophilized substances without involving substantial mixing, shaking or other types of agitation. In some embodiments, the present invention provides a method of reconstituting a lyophilized substance by including the steps of providing a container containing a lyophilized substance, introducing a diluent into the container so that the diluent and the lyophilized substance come into contact with each other while maintaining the container substantially still until the lyophilized substance is substantially dissolved.
摘要翻译：本发明涉及用于重构冻干物质的鲁棒，可重现和方便的方法。除其他之外，本发明提供了重组冻干物质而不涉及大量混合，摇动或其它类型的搅动的方法。在一些实施方案中，本发明提供了一种重组冻干物质的方法，包括以下步骤：提供含有冻干物质的容器，将稀释剂引入容器中，使得稀释剂和冻干物质彼此接触，同时保持容器基本上仍然直到冻干物质基本上溶解。

8. 发明申请

WO2009158529A2 LYOPHILIZATION CYCLE ROBUSTNESS STRATEGY 审中-公开
标题翻译： LYOPHILIZATION CYCLE ROBUSTNESS策略
公开(公告)号：WO2009158529A2
公开(公告)日：2009-12-30
申请号：PCT/US2009/048708
申请日：2009-06-25
申请人： STRAHER, Michael, P. , TCHESSALOV, Serguei , DIXON, Daniel , BARRY, Anthony , WARNE, Nicholas
发明人： TCHESSALOV, Serguei , DIXON, Daniel , BARRY, Anthony , WARNE, Nicholas
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。

9. 发明申请

WO2008042408A2 LYOPHILIZATION METHODS AND APPARATUSES 审中-公开
标题翻译： LYOPHILIZATION方法和设备
公开(公告)号：WO2008042408A2
公开(公告)日：2008-04-10
申请号：PCT/US2007/021240
申请日：2007-10-03
申请人： WYETH , TCHESSALOV, Serguei, A. , WARNE, Nick
发明人： TCHESSALOV, Serguei, A. , WARNE, Nick
IPC分类号： F26B5/06
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。

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