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    Lyophilization methods and apparatuses
    3.
    发明申请
    Lyophilization methods and apparatuses 审中-公开
    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。

    LYOPHILIZATION ABOVE COLLAPSE
    5.
    发明申请
    LYOPHILIZATION ABOVE COLLAPSE 有权
    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。

    Albumin-free factor VIII formulations
    6.
    发明授权
    Albumin-free factor VIII formulations 有权
    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。

    NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS
    7.
    发明申请
    NOVEL ALBUMIN-FREE FACTOR VIII FORMULATIONS 有权
    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。

    Albumin-free factor VIII formulations
    8.
    发明授权
    Albumin-free factor VIII formulations 有权
    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。

    Albumin-free factor VIII formulations
    9.
    发明授权
    Albumin-free factor VIII formulations 有权
    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。

    Novel albumin-free factor VIII formulations
    10.
    发明申请
    Novel albumin-free factor VIII formulations 有权
    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。