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1. 发明申请

WO2007136693A3 PREDICTION OF RELATIVE POLYPEPTIDE SOLUBILITY BY POLYETHYLENE GLYCOL PRECIPITATION 审中-公开
标题翻译：通过聚乙二醇降解预测相对多肽溶解度
公开(公告)号：WO2007136693A3
公开(公告)日：2008-01-17
申请号：PCT/US2007011818
申请日：2007-05-17
申请人： WYETH CORP , LI LI , KANTOR ANGELA , WARNE NICHOLAS W
发明人： LI LI , KANTOR ANGELA , WARNE NICHOLAS W
IPC分类号： G01N33/68
CPC分类号： G01N33/68 , G01N33/6803
摘要： A method is described for predicting the relative solubility of a polypeptide using polyethylene glycol (PEG) based volume exclusion precipitation. Different polypeptides can be tested for their solubilities relative to each other or relative to a reference. A single polypeptide can be tested for its relative solubility under different experimental conditions. The solubility determinations can be made by comparison based on graphs plotting the log solubility of the polypeptide against a range of PEG concentrations. Additionally, a method is provided for the high throughput visual or automated screening of multiple polypeptides for relative solubility differences, in a method that can omit the step of measuring the actual solubility or actual amount of precipitation of each sample at each PEG concentration.
摘要翻译：描述了一种用于使用基于聚乙二醇（PEG）的体积排阻沉淀来预测多肽的相对溶解度的方法。可以测试不同的多肽相对于彼此或相对于参考物的溶解度。可以在不同的实验条件下测试单个多肽的相对溶解度。可以基于绘制多肽对一定范围的PEG浓度的对数溶解度的图表进行比较来进行溶解度测定。此外，提供了一种方法，可以省略在每个PEG浓度下测量每个样品的实际溶解度或实际沉淀量的步骤，用于多个多肽的高通量视觉或自动筛选相对溶解度差异。

2. 发明申请

WO2007146268A3 METHODS FOR REDUCING OR PREVENTING LIQUID-LIQUID PHASE SEPARATION IN HIGH CONCENTRATION PROTEIN SALUTIONS 审中-公开
标题翻译：降低或预防高浓度蛋白质中液相液相分离的方法
公开(公告)号：WO2007146268A3
公开(公告)日：2008-02-28
申请号：PCT/US2007013747
申请日：2007-06-12
申请人： WYETH CORP , LI LI , KANTOR ANGELA , WARNE NICHOLAS W
发明人： LI LI , KANTOR ANGELA , WARNE NICHOLAS W
IPC分类号： B01D37/00
CPC分类号： C07K1/36
摘要： Methods of formulating proteins at high concentrations in protein solutions, wherein the protein solutions lack or have reduced liquid-liquid phase separation are described. Such protein solutions are substantially clear and substantially homogenous. Additionally, methods of concentrating and purifying proteins using liquid-liquid phase separation are provided.
摘要翻译：在蛋白质溶液中配制高浓度蛋白质的方法，其中蛋白质溶液缺乏或液 - 液相分离减少。这种蛋白质溶液基本上是清楚的并且基本上均匀。另外，提供了使用液 - 液相分离来浓缩和纯化蛋白质的方法。

3. 发明申请

WO2006083689A3 ANTI A BETA ANTIBODY FORMULATION 审中-公开
标题翻译：抗Aβ抗体制剂
公开(公告)号：WO2006083689A3
公开(公告)日：2006-10-19
申请号：PCT/US2006002837
申请日：2006-01-27
申请人： NEURALAB LTD , WYETH CORP , LUISI DONNA , WARNE NICHOLAS W , KANTOR ANGELA
发明人： LUISI DONNA , WARNE NICHOLAS W , KANTOR ANGELA
IPC分类号： A61K39/395 , C07K16/18
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/19 , A61K31/198 , A61K31/4172 , A61K39/39591 , A61K47/02 , A61K47/183 , C07K16/18 , C07K2317/24
摘要： The present invention provides formulations for maintaining the stability of Aß binding polypeptides, for example, Aß antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.
摘要翻译：本发明提供了用于维持Aβ结合多肽（例如Aβ抗体）稳定性的制剂。示例性制剂包括张度剂如甘露醇和缓冲剂或氨基酸如组氨酸。其他示例性制剂包括足够量的抗氧化剂以抑制副产物形成，例如形成高分子量多肽聚集体，低分子量多肽降解片段及其混合物。本发明的制剂任选地包含张度剂，例如甘露醇，和缓冲剂或氨基酸例如组氨酸。该制剂适用于几种不同的施用途径。

4. 发明申请

WO2006081587A3 STABILIZED LIQUID POLYPEPTIDE FORMULATIONS 审中-公开
标题翻译：稳定的液体多肽制剂
公开(公告)号：WO2006081587A3
公开(公告)日：2006-10-12
申请号：PCT/US2006004741
申请日：2006-01-27
申请人： WYETH CORP , LUISI DONNA , WARNE NICHOLAS W , KANTOR ANGELA
发明人： LUISI DONNA , WARNE NICHOLAS W , KANTOR ANGELA
IPC分类号： A61K39/395 , C07K16/18
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/08 , A61K31/198 , A61K31/4172 , A61K39/39591 , A61K47/02 , A61K47/183 , A61K47/22 , A61K2039/505 , C07K16/18 , C07K2317/24 , C07K2317/56
摘要： The present invention provides formulations for maintaining the stability of polypeptides, in particular, therapeutic antigen-binding polypeptides such as antibodies and the like, for example, anti-Aß antibodies. The formulations generally include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine, and thus, the formulations are suitable for several different routes of administration.
摘要翻译：本发明提供了用于维持多肽，特别是治疗性抗原结合多肽如抗体等的稳定性的制剂，例如抗Aβ抗体。制剂通常包含足够量的抗氧化剂以抑制副产物形成，例如形成高分子量多肽聚集体，低分子量多肽降解片段及其混合物。本发明的制剂任选地包含张度剂（例如甘露糖醇）和缓冲剂或氨基酸（例如组氨酸），并且因此所述制剂适用于几种不同的施用途径。

5. 发明申请

WO2008101179A8 USE OF SUCROSE TO SUPPRESS MANNITOL-INDUCED PROTEIN AGGREGATION 审中-公开
标题翻译：使用西红柿抑制曼尼托醇诱导的蛋白质聚集
公开(公告)号：WO2008101179A8
公开(公告)日：2009-09-17
申请号：PCT/US2008054115
申请日：2008-02-15
申请人： WYETH CORP , SEK DAVID C , WARNE NICHOLAS W , HO KIN , LUISI DONNA L , KANTOR ANGELA
发明人： SEK DAVID C , WARNE NICHOLAS W , HO KIN , LUISI DONNA L , KANTOR ANGELA
IPC分类号： A61K9/10 , A61K38/00 , A61K39/395 , A61K47/26
CPC分类号： A61K9/10 , A61K39/39591 , A61K47/26
摘要： The present invention provides a method for suppressing mannitol-induced protein aggregation by providing sucrose to a liquid formulation containing a protein. The present invention also provides methods for storing and preparing a liquid formulation containing a protein and a combination of mannitol and sucrose such that the presence of sucrose suppresses mannitol-induced protein aggregation.
摘要翻译：本发明提供了通过向含有蛋白质的液体制剂提供蔗糖来抑制甘露醇诱导的蛋白质聚集的方法。本发明还提供了用于储存和制备含有蛋白质和甘露糖醇和蔗糖的组合的液体制剂的方法，使得蔗糖的存在抑制甘露醇诱导的蛋白质聚集。

6. 发明申请

WO2008101179A3 USE OF SUCROSE TO SUPPRESS MANNITOL-INDUCED PROTEIN AGGREGATION 审中-公开
标题翻译：使用蔗糖来抑制甘露醇诱导的蛋白质聚集
公开(公告)号：WO2008101179A3
公开(公告)日：2008-12-24
申请号：PCT/US2008054115
申请日：2008-02-15
申请人： WYETH CORP , SEK DAVID C , WARNE NICHOLAS W , HO KIN , LUISI DONNA L , KANTOR ANGELA
发明人： SEK DAVID C , WARNE NICHOLAS W , HO KIN , LUISI DONNA L , KANTOR ANGELA
IPC分类号： A61K9/10 , A61K38/00 , A61K39/395 , A61K47/26
CPC分类号： A61K9/10 , A61K39/39591 , A61K47/26
摘要： The present invention provides a method for suppressing rnannitol-induced protein aggregation by providing sucrose to a liquid formulation containing a protein. The present invention also provides methods for storing and preparing a liquid formulation containing a protein and a combination of mannitol and sucrose such that the presence of sucrose suppresses mannitol-induced protein aggregation.
摘要翻译：本发明提供了通过向含有蛋白质的液体制剂提供蔗糖来抑制甘露醇诱导的蛋白质聚集的方法。本发明还提供了用于储存和制备含有蛋白质和甘露醇与蔗糖的组合的液体制剂的方法，使得蔗糖的存在抑制甘露醇诱导的蛋白质聚集。

7. 发明申请

WO2006020935A2 STABILIZING FORMULATIONS 审中-公开
标题翻译：稳定配方
公开(公告)号：WO2006020935A2
公开(公告)日：2006-02-23
申请号：PCT/US2005028861
申请日：2005-08-12
申请人： WYETH CORP , LI LI , KANTOR ANGELA , MACMILLAN SHANNON B
发明人： LI LI , KANTOR ANGELA , MACMILLAN SHANNON B
IPC分类号： G01N33/531
CPC分类号： A61K9/2886 , C07K16/065 , C07K16/2803 , C07K16/2896 , C07K16/30 , C07K2317/24
摘要： Formulations are described that are suitable for storage of proteins, such as antibodies, over a relatively broad range of protein concentrations, pH, and buffer types. Also described are methods of storing a protein and methods of identifying a suitable formulation for storage of a specific protein. In general, a formulation contains low to no surfactant, no to relatively low salt concentrations, and requires a relatively low buffer concentration.
摘要翻译：描述了适合于在相对宽的蛋白质浓度，pH和缓冲液类型范围内存储蛋白质（例如抗体）的制剂。还描述了存储蛋白质的方法和鉴定用于储存特定蛋白质的合适制剂的方法。通常，制剂含有低至无表面活性剂，不含相对较低的盐浓度，并且需要相对较低的缓冲液浓度。

8. 发明申请

WO2007109221A9 METHODS FOR REDUCING PROTEIN AGGREGATION 审中-公开
标题翻译：降低蛋白质聚集的方法
公开(公告)号：WO2007109221A9
公开(公告)日：2007-12-06
申请号：PCT/US2007006787
申请日：2007-03-19
申请人： WYETH CORP , WARNE NICHOLAS WILLIAM , KANTOR ANGELA , CROWLEY THOMAS JOSEPH , SOLEY ERIN CHRISTINE , LI LI , LUKSHA NICHOLAS GARY , NEIDHARDT EDIE ANNA
发明人： WARNE NICHOLAS WILLIAM , KANTOR ANGELA , CROWLEY THOMAS JOSEPH , SOLEY ERIN CHRISTINE , LI LI , LUKSHA NICHOLAS GARY , NEIDHARDT EDIE ANNA
IPC分类号： A61K39/395
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/19 , A61K38/00 , A61K47/183 , A61K47/26 , C07K2319/30
摘要： Methods of reducing aggregation of a protein or proteins in a formulation, and protein formu
摘要翻译：降低制剂中蛋白质或蛋白质聚集的方法和蛋白质制剂

9. 发明申请

WO2007109221A3 METHODS FOR REDUCING PROTEIN AGGREGATION 审中-公开
标题翻译：降低蛋白质聚集的方法
公开(公告)号：WO2007109221A3
公开(公告)日：2008-02-21
申请号：PCT/US2007006787
申请日：2007-03-19
申请人： WYETH CORP , WARNE NICHOLAS WILLIAM , KANTOR ANGELA , CROWLEY THOMAS JOSEPH , SOLEY ERIN CHRISTINE , LI LI , LUKSHA NICHOLAS GARY , NEIDHARDT EDIE ANNA
发明人： WARNE NICHOLAS WILLIAM , KANTOR ANGELA , CROWLEY THOMAS JOSEPH , SOLEY ERIN CHRISTINE , LI LI , LUKSHA NICHOLAS GARY , NEIDHARDT EDIE ANNA
IPC分类号： A61K38/20 , A61K38/37 , A61K39/395 , A61K47/18 , C07K16/28
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/19 , A61K38/00 , A61K47/183 , A61K47/26 , C07K2319/30
摘要： Methods of reducing aggregation of a protein or proteins in a formulation, and protein formulations having reduced aggregation properties are provided. The methods and formulations described herein maintain the biological activity of a protein and increase the shelf life of protein formulations.
摘要翻译：提供减少制剂中蛋白质或蛋白质聚集的方法，以及具有降低聚集性质的蛋白质制剂。本文所述的方法和制剂维持蛋白质的生物活性并增加蛋白质制剂的保质期。

10. 发明专利

CR10290A METODOS PARA REDUCIR LA AGLOMERACION DE PROTEINA 未知
公开(公告)号：CR10290A
公开(公告)日：2008-11-26
申请号：CR10290
申请日：2008-09-16
申请人： WYETH CORP
发明人： WARNE NCHOLAS WILLIAM , KANTOR ANGELA , CROWLEY THOMAS JOSEPH , SOLEY ERIN CHRISTINE , LI LI , LUKSHA NICHOLAS GARY , NEIDHARDT EDIE ANNA
IPC分类号： A61K39/395
摘要： La presente invencion se refiere a metodos para reduicr la aglomeracion de una proteina o proteinas en una formulacion y formulaciones de proteinas que tienen propiedades de aglomeracion reducidas. Los metodos y formulaciones descritas en este documento, mantienen la actividad biologica de una proteina e incrementan la vida de anaquel de las formulaciones de proteina.

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