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1. 发明申请

WO2009009629A1 PROCESS FOR PRODUCING ALUMINUM PHOSPHATE 审中-公开
标题翻译：生产磷酸铝的方法
公开(公告)号：WO2009009629A1
公开(公告)日：2009-01-15
申请号：PCT/US2008/069584
申请日：2008-07-10
申请人： WYETH , KHANDKE, Lakshmi , PEREZ, Joseph
发明人： KHANDKE, Lakshmi , PEREZ, Joseph
IPC分类号： C01B25/36
CPC分类号： C01B25/36 , A61K33/06 , A61K33/42
摘要： The present invention provides improved methods for producing the aluminum adjuvant AlPO 4 . In one aspect, the present invention provides a method for producing aluminum phosphate which comprises the steps of mixing a solution of aluminum chloride and a solution of sodium phosphate tribasic to produce an aluminum phosphate precipitate, wherein the improvement comprises settling the aluminum phosphate precipitate at a temperature in the range of about 50° C to about 70° C. In another aspect, the present invention is directed to methods for producing aluminum phosphate within a closed system.
摘要翻译：本发明提供了用于生产铝佐剂AlPO 4的改进方法。一方面，本发明提供了一种生产磷酸铝的方法，其包括以下步骤：将氯化铝溶液和三磷酸钠溶液混合以产生磷酸铝沉淀物，其中所述改进包括将磷酸铝沉淀物沉淀在温度在约50℃至约70℃的范围内。另一方面，本发明涉及在封闭系统内生产磷酸铝的方法。

2. 发明申请

WO2007055952A2 PROCESS FOR PRODUCING STABLE HIV TH-CTL PEPTIDES 审中-公开
标题翻译：生产稳定的HIV TH-CTL肽的方法
公开(公告)号：WO2007055952A2
公开(公告)日：2007-05-18
申请号：PCT/US2006042364
申请日：2006-11-01
申请人： WYETH CORP , KHANDKE LAKSHMI , SARPAL RANJIT , YANG XUDONG CINDY
发明人： KHANDKE LAKSHMI , SARPAL RANJIT , YANG XUDONG CINDY
IPC分类号： C07K14/43
CPC分类号： C07K14/005 , A61K2039/55522 , C12N2740/16122 , C12N2740/16222 , C12N2740/16322
摘要： A process for producing a stable formulation of hydrophobic HIV Th/CTL peptides first requires the preparation of a formulation buffer containing 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1. The hydrophobic peptides are then dissolved in the formulation buffer, filtered and lyophilized. Prior to use, the lyophilized peptides are reconstituted with 12.5 mM sodium succinate, and then mixed with at least one adjuvant to produce an immunogenic composition that is stable at 2-8°C for at least three hours.
摘要翻译：制备疏水性HIV Th / CTL肽的稳定制剂的方法首先需要制备含有12.5mM琥珀酸和3％甘露醇的制剂缓冲液，并将制剂缓冲液的pH调节至1.7至2.1。然后将疏水性肽溶解在制剂缓冲液中，过滤并冻干。使用前，将冻干的肽用12.5mM琥珀酸钠重构，然后与至少一种佐剂混合以产生在2-8℃下稳定至少3小时的免疫原性组合物。

3. 发明申请

WO2011151760A2 VACCINE FORMULATIONS 审中-公开
标题翻译：疫苗配方
公开(公告)号：WO2011151760A2
公开(公告)日：2011-12-08
申请号：PCT/IB2011052275
申请日：2011-05-25
申请人： WYETH LLC , KHANDKE LAKSHMI , RASHIDBAIGI ABBAS
发明人： KHANDKE LAKSHMI , RASHIDBAIGI ABBAS
IPC分类号： A61K39/09 , A61P31/04
CPC分类号： A61K39/385 , A61K39/092 , A61K2039/55505 , A61K2039/6037 , A61K2039/70 , A61M5/24 , A61M5/3129
摘要： An immunogenic composition comprising a plurality of capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative- containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided.
摘要翻译：一种免疫原性组合物，其包含与载体蛋白缀合的多个来自肺炎链球菌血清型1,2,3,4,5,6A，6B，7F，9V，14,18C，19A，19F和23F的荚膜多糖，并且还包含至少一种防腐剂，优选2-苯氧基乙醇（2-PE）。本发明的含防腐剂的免疫原性组合物赋予对一种或多种微生物的抗性，并且可用于产生相对于选择的免疫原性组合物中不同抗原决定簇的长期稳定性具有有利性质的多剂量疫苗制剂。还提供了用于测量疫苗制剂中一种或多种防腐剂的功效的相关组合物和方法。

4. 发明申请

WO2012085872A3 STABLE IMMUNOGENIC COMPOSITIONS OF STAPHYLOCOCCUS AUREUS ANTIGENS 审中-公开
公开(公告)号：WO2012085872A3
公开(公告)日：2012-06-28
申请号：PCT/IB2011/055883
申请日：2011-12-21
申请人： WYETH LLC , KHANDKE, Lakshmi , NONOYAMA, Akihisa , HODGE, Tamara Shafer , NEMA, Sandeep
发明人： KHANDKE, Lakshmi , NONOYAMA, Akihisa , HODGE, Tamara Shafer , NEMA, Sandeep
IPC分类号： A61K39/085 , C07K16/12
摘要： The present invention is directed towards a lyophilized or reconstituted multi- antigen or multicomponent immunogenic composition comprising at least one antigen isolated from a staphylococcal bacterium, and methods of making the same.

5. 发明申请

WO2007055952A3 PROCESS FOR PRODUCING STABLE HIV TH-CTL PEPTIDES 审中-公开
公开(公告)号：WO2007055952A3
公开(公告)日：2007-05-18
申请号：PCT/US2006/042364
申请日：2006-11-01
申请人： WYETH , KHANDKE, Lakshmi , SARPAL, Ranjit , YANG, Xudong Cindy
发明人： KHANDKE, Lakshmi , SARPAL, Ranjit , YANG, Xudong Cindy
IPC分类号： C07K14/16 , A61K39/21 , A61K39/39
摘要： A process for producing a stable formulation of hydrophobic HIV Th/CTL peptides first requires the preparation of a formulation buffer containing 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1. The hydrophobic peptides are then dissolved in the formulation buffer, filtered and lyophilized. Prior to use, the lyophilized peptides are reconstituted with 12.5 mM sodium succinate, and then mixed with at least one adjuvant to produce an immunogenic composition that is stable at 2-8°C for at least three hours.

6. 发明申请

WO2011151760A3 STREPTOCOCCUS PNEUMONIAE VACCINE FORMULATIONS 审中-公开
公开(公告)号：WO2011151760A3
公开(公告)日：2011-12-08
申请号：PCT/IB2011/052275
申请日：2011-05-25
申请人： WYETH LLC , KHANDKE, Lakshmi , RASHIDBAIGI, Abbas
发明人： KHANDKE, Lakshmi , RASHIDBAIGI, Abbas
IPC分类号： A61K39/09 , A61P31/04
摘要： An immunogenic composition comprising a plurality of capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative- containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided.

7. 发明申请

WO2012085872A2 STABLE IMMUNOGENIC COMPOSITIONS OF STAPHYLOCOCCUS AUREUS ANTIGENS 审中-公开
标题翻译：金黄色葡萄球菌抗原的稳定免疫原性组合物
公开(公告)号：WO2012085872A2
公开(公告)日：2012-06-28
申请号：PCT/IB2011055883
申请日：2011-12-21
申请人： WYETH LLC , KHANDKE LAKSHMI , NONOYAMA AKIHISA , HODGE TAMARA SHAFER , NEMA SANDEEP
发明人： KHANDKE LAKSHMI , NONOYAMA AKIHISA , HODGE TAMARA SHAFER , NEMA SANDEEP
IPC分类号： A61K39/085 , C07K16/12
CPC分类号： A61K39/085 , A61K2039/6037
摘要： The present invention is directed towards a lyophilized or reconstituted multi- antigen or multicomponent immunogenic composition comprising at least one antigen isolated from a staphylococcal bacterium, and methods of making the same.
摘要翻译：本发明涉及包含从葡萄球菌细菌分离的至少一种抗原的冻干或重构多抗原或多组分免疫原性组合物及其制备方法。

8. 发明申请

WO2012025873A3 STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS 审中-公开
标题翻译： NEISSERIA MENINGITIDIS rLP2086抗原的稳定配方
公开(公告)号：WO2012025873A3
公开(公告)日：2012-05-18
申请号：PCT/IB2011053684
申请日：2011-08-22
申请人： WYETH LLC , KHANDKE LAKSHMI , ARUMUGHAM RASAPPA , LOUN BOUNTHON
发明人： KHANDKE LAKSHMI , ARUMUGHAM RASAPPA , LOUN BOUNTHON
IPC分类号： A61K39/095 , A61K47/02 , A61K47/34 , A61K47/44 , G01N33/569
CPC分类号： C07K14/22 , A61K31/194 , A61K31/4172 , A61K38/164 , A61K39/095 , A61K2039/55505 , A61K2039/55555 , G01N33/56911
摘要： The present invention relates to stable formulations of Neisseria meningitis r LP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation of Neisseria meningitis rLP2086 Antigens and methods for determining the potency of Neisseria meningitis r LP2086 antigens.
摘要翻译：本发明涉及免疫原性组合物中脑膜炎奈瑟氏球菌r LP2086亚族B抗原的稳定制剂。本发明还涉及保留脑膜炎奈瑟氏球菌rLP2086抗原构象的方法和确定脑膜炎奈瑟氏球菌LP2086抗原效力的方法。

9. 发明申请

WO2012025873A2 STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS 审中-公开
标题翻译： NEISSERIA MENINGITIDIS rLP2086抗原的稳定制剂
公开(公告)号：WO2012025873A2
公开(公告)日：2012-03-01
申请号：PCT/IB2011/053684
申请日：2011-08-22
申请人： WYETH LLC , KHANDKE, Lakshmi , ARUMUGHAM, Rasappa , LOUN, Bounthon
发明人： KHANDKE, Lakshmi , ARUMUGHAM, Rasappa , LOUN, Bounthon
IPC分类号： A61K39/095
CPC分类号： C07K14/22 , A61K31/194 , A61K31/4172 , A61K38/164 , A61K39/095 , A61K2039/55505 , A61K2039/55555 , G01N33/56911
摘要： The present invention relates to stable formulations of Neisseria meningitis r LP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation of Neisseria meningitis rLP2086 Antigens and methods for determining the potency of Neisseria meningitis r LP2086 antigens.
摘要翻译：本发明涉及免疫原性组合物中脑膜炎奈瑟氏球菌rLP2086亚家族B抗原的稳定制剂。本发明还涉及保存脑膜炎奈瑟球菌rLP2086抗原构象的方法和确定脑膜炎奈瑟球菌r LP2086抗原效力的方法。

10. 发明申请

WO2007127665A3 NOVEL FORMULATIONS WHICH STABILIZE AND INHIBIT PRECIPITATION OF IMMUNOGENIC COMPOSITIONS 审中-公开
标题翻译：稳定和抑制免疫组化降解的新型配方
公开(公告)号：WO2007127665A3
公开(公告)日：2008-11-13
申请号：PCT/US2007066959
申请日：2007-04-19
申请人： WYETH CORP , KHANDKE LAKSHMI , CHEN YING , HAN HANYOUNG , SEID ROBERT CHANCEY JR , JIN ZHAOWEI , LOOK JEE LOON , MALONE RONALD , YANG XUDONG
发明人： KHANDKE LAKSHMI , CHEN YING , HAN HANYOUNG , SEID ROBERT CHANCEY JR , JIN ZHAOWEI , LOOK JEE LOON , MALONE RONALD , YANG XUDONG
IPC分类号： A61K47/12 , A61K47/48
CPC分类号： A61K47/26 , A61K39/09 , A61K39/092 , A61K39/095 , A61K47/646 , A61K2039/55505 , A61K2039/55583 , A61K2039/57 , A61K2039/6018 , A61K2039/6037
摘要： The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e.g., aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.
摘要翻译：本发明解决了本领域持续的需要，以提高免疫原性组合物如多糖 - 蛋白质缀合物和蛋白质免疫原的稳定性。本发明广泛涉及稳定和抑制免疫原性组合物沉淀的新型制剂。更具体地说，下文描述的发明解决了本领域对于稳定和抑制在诸如以下的容器装置中加工，开发，配制，制造和/或储存的免疫原性组合物的颗粒形成（例如，聚集，沉淀）的制剂的需要。发酵罐，生物反应器，小瓶，烧瓶，袋子，注射器，橡胶塞子，管道等。

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