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1. 发明申请

US20080070230A1 Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions 审中-公开
标题翻译：降低或防止高浓度蛋白质溶液中液 - 液相分离的方法
公开(公告)号：US20080070230A1
公开(公告)日：2008-03-20
申请号：US11811517
申请日：2007-06-11
申请人： Li Li , Angela Kantor , Nicholas Warne
发明人： Li Li , Angela Kantor , Nicholas Warne
IPC分类号： G01N33/536 , C07K1/00 , G01N33/00
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。

2. 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。

3. 发明申请

US20080064856A1 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：US20080064856A1
公开(公告)日：2008-03-13
申请号：US11725534
申请日：2007-03-19
申请人： Nicholas Warne , Angela Kantor , Thomas Crowley , Erin Soley , Li Li , Nicholas Luksha , Edie Neidhardt
发明人： Nicholas Warne , Angela Kantor , Thomas Crowley , Erin Soley , Li Li , Nicholas Luksha , Edie Neidhardt
IPC分类号： C07K14/755 , C07K1/14 , C07K14/00
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：提供了减少制剂中蛋白质或蛋白质聚集的方法，以及具有降低的聚集性质的蛋白质制剂。本文描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。

4. 发明申请

US20080003686A1 Prediction of relative polypeptide solubility by polyethylene glycol precipitation 审中-公开
标题翻译：通过聚乙二醇沉淀预测相对多肽溶解度
公开(公告)号：US20080003686A1
公开(公告)日：2008-01-03
申请号：US11804191
申请日：2007-05-17
申请人： Li Li , Angela Kantor , Nicholas Warne
发明人： Li Li , Angela Kantor , Nicholas Warne
IPC分类号： G01N33/00
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。

5. 发明申请

US20090311241A9 Human antibodies that bind human IL-12 and methods for producing 有权
标题翻译：结合人IL-12的人抗体及其生产方法
公开(公告)号：US20090311241A9
公开(公告)日：2009-12-17
申请号：US11645287
申请日：2006-12-22
申请人： Jochen Salfeld , Michael Roguska , Michael Paskind , Subhashis Banerjee , Daniel Tracey , Michael White , Zehra Kaymakcalan , Boris Labkovsky , Paul Sakorafas , Geertruida Veldman , Amy Venturini , Angela Widom , Stuart Friedrich , Nicholas Warne , Angela Kantor , John Elvin , Alexander Duncan , Elaine Derbyshire , Sara Carmen , Stephen Smith , Thor Holtet , Sarah Du Fou
发明人： Jochen Salfeld , Michael Roguska , Michael Paskind , Subhashis Banerjee , Daniel Tracey , Michael White , Zehra Kaymakcalan , Boris Labkovsky , Paul Sakorafas , Geertruida Veldman , Amy Venturini , Angela Widom , Stuart Friedrich , Nicholas Warne , Angela Kantor , John Elvin , Alexander Duncan , Elaine Derbyshire , Sara Carmen , Stephen Smith , Thor Holtet , Sarah Du Fou
IPC分类号： A61K39/395 , A61P37/00 , C07K14/54 , C07K16/24 , G01N33/00
CPC分类号： C07K16/244 , A61K2039/505 , C07K2317/21 , C07K2317/30 , C07K2317/33 , C07K2317/56 , C07K2317/565 , C07K2317/73 , C07K2317/76 , C07K2317/92
摘要： Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.
摘要翻译：公开了特异性结合人白细胞介素-12（hIL-12）的人抗体，优选重组人抗体。优选的抗体对hIL-12具有高亲和力，并在体外和体内中和hIL-12活性。本发明的抗体可以是全长抗体或其抗原结合部分。本发明的抗体或抗体部分可用于检测hIL-12和抑制hIL-12活性，例如在患有hIL-12活性有害的病症的人类受试者中。用于表达本发明的重组人抗体的核酸，载体和宿主细胞以及合成重组人抗体的方法也包括在本发明中。

6. 发明申请

US20060193850A1 Anti a beta antibody formulation 有权
标题翻译：抗β抗体制剂
公开(公告)号：US20060193850A1
公开(公告)日：2006-08-31
申请号：US11342353
申请日：2006-01-27
申请人： Nicholas Warne , Donna Luisi , Angela Kantor
发明人： Nicholas Warne , Donna Luisi , Angela Kantor
IPC分类号： A61K39/395 , A61K31/4172 , A61K31/198
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 Aβ binding polypeptides, for example, Aβ 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Abeta抗体的稳定性的制剂。示例性制剂包括张力剂如甘露醇和缓冲剂或氨基酸如组氨酸。其它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力剂，例如甘露醇，缓冲剂或氨基酸，例如组氨酸。该制剂适用于几种不同的给药途径。

7. 发明申请

US20080063634A1 Human antibodies that bind human IL-12 and methods for producing 有权
标题翻译：结合人IL-12的人抗体及其生产方法
公开(公告)号：US20080063634A1
公开(公告)日：2008-03-13
申请号：US11645287
申请日：2006-12-22
申请人： Jochen Salfeld , Michael Roguska , Michael Paskind , Subhashis Banerjee , Daniel Tracey , Michael White , Zehra Kaymakcalan , Boris Labkovsky , Paul Sakorafas , Geertruida Veldman , Amy Venturini , Angela Widom , Stuart Friedrich , Nicholas Warne , Angela Kantor , John Elvin , Alexander Duncan , Elaine Derbyshire , Sara Carmen , Stephen Smith , Thor Holtet , Sarah Du Fou
发明人： Jochen Salfeld , Michael Roguska , Michael Paskind , Subhashis Banerjee , Daniel Tracey , Michael White , Zehra Kaymakcalan , Boris Labkovsky , Paul Sakorafas , Geertruida Veldman , Amy Venturini , Angela Widom , Stuart Friedrich , Nicholas Warne , Angela Kantor , John Elvin , Alexander Duncan , Elaine Derbyshire , Sara Carmen , Stephen Smith , Thor Holtet , Sarah Du Fou
IPC分类号： A61K39/395 , A61P37/00 , C07K14/54 , C07K16/24 , G01N33/00
CPC分类号： C07K16/244 , A61K2039/505 , C07K2317/21 , C07K2317/30 , C07K2317/33 , C07K2317/56 , C07K2317/565 , C07K2317/73 , C07K2317/76 , C07K2317/92
摘要： Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.
摘要翻译：公开了特异性结合人白细胞介素-12（hIL-12）的人抗体，优选重组人抗体。优选的抗体对hIL-12具有高亲和力，并在体外和体内中和hIL-12活性。本发明的抗体可以是全长抗体或其抗原结合部分。本发明的抗体或抗体部分可用于检测hIL-12和抑制hIL-12活性，例如在患有hIL-12活性有害的病症的人类受试者中。用于表达本发明的重组人抗体的核酸，载体和宿主细胞以及合成重组人抗体的方法也包括在本发明中。

8. 发明申请

US20060210557A1 Stabilized liquid polypeptide formulations 审中-公开
标题翻译：稳定液体多肽制剂
公开(公告)号：US20060210557A1
公开(公告)日：2006-09-21
申请号：US11342252
申请日：2006-01-27
申请人： Donna Luisi , Nicholas Warne , Angela Kantor
发明人： Donna Luisi , Nicholas Warne , Angela Kantor
IPC分类号： A61K39/395 , A61K31/4172 , A61K31/198
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-Aβ 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：本发明提供用于维持多肽的稳定性，特别是治疗性抗原结合多肽如抗体等的抗体，例如抗Aβ抗体的制剂。制剂通常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，例如甘露糖醇，缓冲剂或氨基酸，例如组氨酸，因此，该制剂适合于几种不同的给药途径。

9. 发明申请

US20070237758A1 IMMUNOGLOBULIN FUSION PROTEIN FORMULATIONS 审中-公开
标题翻译：免疫球蛋白融合蛋白制剂
公开(公告)号：US20070237758A1
公开(公告)日：2007-10-11
申请号：US11562299
申请日：2006-11-21
申请人： Anthony Barry , Thomas Crowley , Daniel Dixon , Jennifer Juneau , Ajay Kumar , Li Li , Nicholas Luksha , Michael Shamashkin , Erin Soley , Nicholas Warne , Chandra Webb
发明人： Anthony Barry , Thomas Crowley , Daniel Dixon , Jennifer Juneau , Ajay Kumar , Li Li , Nicholas Luksha , Michael Shamashkin , Erin Soley , Nicholas Warne , Chandra Webb
IPC分类号： A61K39/395
CPC分类号： C07K14/7155 , A61K38/1774 , C07K14/705 , C07K2319/30 , C07K2319/31
摘要： The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.
摘要翻译：本发明提供Ig融合蛋白的组合物，特别是包含Ig融合蛋白，填充剂，二糖，表面活性剂和缓冲液的组合物。在一个方面，这些组合物在长期储存或至少一个冷冻/融化循环下是稳定的。本发明还提供了Ig融合蛋白组合物的制备方法。在一个方面，本发明的组合物被冻干。在另一方面，组合物通过包括退火步骤的方法冻干。

10. 发明申请

US20110033464A1 IMMUNOGLOBULIN FUSION PROTEIN FORMULATIONS 审中-公开
标题翻译：免疫球蛋白融合蛋白制剂
公开(公告)号：US20110033464A1
公开(公告)日：2011-02-10
申请号：US12910146
申请日：2010-10-22
申请人： Anthony BARRY , Thomas Crowley , Daniel Dixon , Jennifer Juneau , Ajay Kumar , Li Li , Nicholas Luksha , Michael Shamashkin , Erin Soley , Nicholas Warne , Chandra Webb
发明人： Anthony BARRY , Thomas Crowley , Daniel Dixon , Jennifer Juneau , Ajay Kumar , Li Li , Nicholas Luksha , Michael Shamashkin , Erin Soley , Nicholas Warne , Chandra Webb
IPC分类号： A61K39/395
CPC分类号： C07K14/7155 , A61K38/1774 , C07K14/705 , C07K2319/30 , C07K2319/31
摘要： The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.
摘要翻译：本发明提供Ig融合蛋白的组合物，特别是包含Ig融合蛋白，填充剂，二糖，表面活性剂和缓冲液的组合物。在一个方面，这些组合物在长期储存或至少一个冷冻/融化循环下是稳定的。本发明还提供了Ig融合蛋白组合物的制备方法。在一个方面，本发明的组合物被冻干。在另一方面，组合物通过包括退火步骤的方法冻干。

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