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1. 发明申请

WO2001041800A3 COMPOSITIONS AND METHODS FOR STABILIZING BIOLOGICAL MOLECULES UPON LYOPHILIZATION 审中-公开
公开(公告)号：WO2001041800A3
公开(公告)日：2001-06-14
申请号：PCT/US2000/042484
申请日：2000-12-01
申请人： CHIRON CORPORATION , ESIKOVA, Irina , WOLFE, Sidney , THOMSON, James , MANINDER, Hora
发明人： ESIKOVA, Irina , WOLFE, Sidney , THOMSON, James , MANINDER, Hora
IPC分类号： A61K39/385
摘要： The present invention is directed to compositions and methods for the preparation of biological molecules, in particular MenC-CRM 197. Biological molecules dissolved in dissolution buffers comprising at least one amorphous excipient and an amorphous buffer exhibit reduced aggregation and proteolytic breakdown.

2. 发明申请

WO0141800A2 COMPOSITIONS AND METHODS FOR STABILIZING BIOLOGICAL MOLECULES UPON LYOPHILIZATION 审中-公开
标题翻译：用于稳定生物分子的组合物和方法
公开(公告)号：WO0141800A2
公开(公告)日：2001-06-14
申请号：PCT/US0042484
申请日：2000-12-01
申请人： CHIRON CORP , ESIKOVA IRINA , WOLFE SIDNEY , THOMSON JAMES , MANINDER HORA
发明人： ESIKOVA IRINA , WOLFE SIDNEY , THOMSON JAMES , MANINDER HORA
IPC分类号： A61K9/19 , A61K39/095 , A61K47/18 , A61K47/22 , A61K47/26 , A61K47/46 , A61P31/10 , A61K39/00
CPC分类号： A61K39/095 , A61K2039/6037
摘要： The present invention is directed to compositions and methods for the preparation of biological molecules, in particular MenC-CRM 197. Biological molecules dissolved in dissolution buffers comprising at least one amorphous excipient and an amorphous buffer exhibit reduced aggregation and proteolytic breakdown.
摘要翻译：本发明涉及用于制备生物分子，特别是MenC-CRM 197的组合物和方法。溶解在包含至少一种无定形赋形剂和无定形缓冲液的溶解缓冲液中的生物分子显示减少的聚集和蛋白水解分解。

3. 发明申请

WO0141800A9 COMPOSITIONS AND METHODS FOR STABILIZING BIOLOGICAL MOLECULES UPON LYOPHILIZATION 审中-公开
标题翻译：用于稳定生物分子的组合物和方法
公开(公告)号：WO0141800A9
公开(公告)日：2002-08-01
申请号：PCT/US0042484
申请日：2000-12-01
申请人： CHIRON CORP , ESIKOVA IRINA , WOLFE SIDNEY , THOMSON JAMES , MANINDER HORA
发明人： ESIKOVA IRINA , WOLFE SIDNEY , THOMSON JAMES , MANINDER HORA
IPC分类号： A61K9/19 , A61K39/095 , A61K47/18 , A61K47/22 , A61K47/26 , A61K47/46 , A61P31/10 , A61K39/385
CPC分类号： A61K39/095 , A61K2039/6037
摘要： The present invention is directed to compositions and methods for the preparation of biological molecules, in particular MenC-CRM 197. Biological molecules dissolved in dissolution buffers comprising at least one amorphous excipient and an amorphous buffer exhibit reduced aggregation and proteolytic breakdown.
摘要翻译：本发明涉及用于制备生物分子，特别是MenC-CRM 197的组合物和方法。溶解在包含至少一种无定形赋形剂和无定形缓冲液的溶解缓冲液中的生物分子显示减少的聚集和蛋白水解分解。

4. 发明申请

US20050266046A1 Novel IGF-1 composition and its use 失效
标题翻译：新型IGF-1组合物及其用途
公开(公告)号：US20050266046A1
公开(公告)日：2005-12-01
申请号：US11195008
申请日：2005-08-02
申请人： Bret Shirley , Maninder Hora
发明人： Bret Shirley , Maninder Hora
IPC分类号： A61K9/00 , A61K9/16 , A61K38/30 , A61K9/22
CPC分类号： A61K38/30 , A61K9/0024 , A61K9/1647 , A61K9/1694
摘要： A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided. The precipitated IGF-I syrup, IGF-I reconstituted from the IGF-I syrup, pharmaceutical compositions, and kits are useful in IGF-I therapy directed to IGF-I-responsive conditions.
摘要翻译：提供了高浓度，低含盐，生物活性糖浆形式的IGF-I或其变体及其制备方法。 IGF-I的这种新型糖浆形式具有至少约250mg / ml的IGF-I浓度，约1.0g / ml至约1.2g / ml的密度，约13,000厘泊（cps）至约在环境温度（23℃）下测量的19,000cps。 IGF-I糖浆通过从溶液中沉淀或分配IGF-I来制备，优选通过调节溶液pH或通过使用溶解度增强剂将IGF-I浓缩在溶液中，然后除去溶解度增强剂。沉淀的糖浆可用作以稳定形式存储IGF-I的手段，并且作为制备包含生物活性IGF-I的组合物的手段。提供了包含该浓缩的IGF-1糖浆的药物组合物和试剂盒。从IGF-I糖浆重建的沉淀的IGF-1糖浆，IGF-I，药物组合物和试剂盒可用于针对IGF-1反应性条件的IGF-1治疗。

5. 发明申请

US20050142110A1 HSA-free formulations of interferon-beta 有权
标题翻译：不含HSA的干扰素-β配方
公开(公告)号：US20050142110A1
公开(公告)日：2005-06-30
申请号：US11062146
申请日：2005-02-18
申请人： Bret Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
发明人： Bret Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
IPC分类号： A61K9/10 , A61K9/14 , A61K9/19 , A61K38/18 , A61K38/21 , A61K47/12 , A61K47/18 , A61K47/26 , A61P1/04 , A61P9/00 , A61P17/06 , A61P21/04 , A61P25/00 , A61P25/02 , A61P25/08 , A61P25/14 , A61P25/16 , A61P25/18 , A61P25/22 , A61P25/28 , A61P29/00 , A61P31/12 , A61P35/00 , A61P37/00 , A61P37/02
CPC分类号： A61K9/0019 , A61K38/1816 , A61K38/215 , A61K47/12 , A61K47/183
摘要： Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.
摘要翻译：提供包含基本上单体的干扰素-β（IFN-β）的稳定的药物组合物和其制备中有用的方法。组合物包含溶解在低离子强度制剂中的IFN-β，其将组合物保持在约3.0至约5.0的pH。提供了制备这些组合物并提高IFN-β在药物组合物中的溶解度的方法。

6. 发明申请

US20060008447A1 Stabilized interferon compositions 有权
公开(公告)号：US20060008447A1
公开(公告)日：2006-01-12
申请号：US11188257
申请日：2005-07-22
申请人： Sidney Wolfe , Maninder Hora
发明人： Sidney Wolfe , Maninder Hora
IPC分类号： A61K38/21
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K38/215 , A61K47/42 , A61K2300/00
摘要： Stabilized pharmaceutical formulations comprising IFN-β and highly purified mannitol are provided. The highly purified mannitol stabilizes the compositions by reducing the formation of IFN-β adducts in comparison with IFN-β formulated with mannitol that has not been highly purified. Methods for increasing the stability of IFN-β or a variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.

7. 发明授权

US06753015B2 Microparticle compositions and methods for the manufacture thereof 有权
公开(公告)号：US06753015B2
公开(公告)日：2004-06-22
申请号：US09967462
申请日：2001-09-28
申请人： Jia-Hwa Fang , Mammohan Singh , Derek O'Hagan , Maninder Hora
发明人： Jia-Hwa Fang , Mammohan Singh , Derek O'Hagan , Maninder Hora
IPC分类号： A61K914
CPC分类号： A61K9/1676 , A61K9/1647
摘要： Microparticles with adsorbed complexes of macromolecule and detergent, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(&agr;-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surfaces of the microparticles have adsorbed thereon a complex of biologically active macromolecules, such as nucleic acids, polypeptides, antigens, and adjuvants, and a detergent. Preferred polymers are poly(D,L-lactide-co-glycolides), more preferably those having a lactide/glycolide molar ratio ranging from 40:60 to 60:40 and having a molecular weight ranging from 30,000 Daltons to 70,000 Daltons. Preferred macromolecules are bacterial and viral antigens (such as HIV antigens, meningitis B antigens, streptococcus B antigens, and Influenza A hemagglutinin antigens) as well as polynucleotides that encode for such antigens.

8. 发明授权

US06573238B2 Method for producing sustained-release formulations 失效
标题翻译：缓释制剂的制备方法
公开(公告)号：US06573238B2
公开(公告)日：2003-06-03
申请号：US09187780
申请日：1998-11-06
申请人： Bret Shirley , Maninder Hora , Derek O'Hagan , Manmohan Singh
发明人： Bret Shirley , Maninder Hora , Derek O'Hagan , Manmohan Singh
IPC分类号： A61K3800
CPC分类号： A61K9/0019 , A61K9/0024 , A61K9/1647 , A61K9/1694 , A61K38/30 , A61K47/183
摘要： Methods for preparing biodegradable microparticles are provided. Also provided are microparticles prepared by the method which include IGF-1 entrapped therein. The microparticles allow for controlled release of IGF-1 and other polypeptides over prolonged periods of time.
摘要翻译：提供了制备可生物降解的微粒的方法。还提供了通过包含IGF-1的方法制备的微粒。微粒允许在长时间内控制释放IGF-1和其他多肽。

9. 发明申请

US20080193415A1 HSA-free formulations of interferon-beta 有权
公开(公告)号：US20080193415A1
公开(公告)日：2008-08-14
申请号：US12082177
申请日：2008-04-09
申请人： Bret A. Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
发明人： Bret A. Shirley , Susan Babuka , Bao-Lu Chen , Maninder Hora , Minna Choe , Melanie Tellers
IPC分类号： A61K38/21
CPC分类号： A61K9/0019 , A61K38/1816 , A61K38/215 , A61K47/12 , A61K47/183
摘要： Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.

10. 发明申请

US20060159679A1 Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants 审中-公开
标题翻译：包含组织因子途径抑制剂或组织因子途径抑制剂变体的稳定的冻干组合物
公开(公告)号：US20060159679A1
公开(公告)日：2006-07-20
申请号：US11385873
申请日：2006-03-22
申请人： Bao-Lu Chen , Maninder Hora
发明人： Bao-Lu Chen , Maninder Hora
IPC分类号： A61K39/395 , A61K31/7012
CPC分类号： A61K9/19 , A61K38/57 , A61K47/183 , A61K47/26
摘要： Lyophilized compositions of TFPI or a TFPI variant suitable for long-term storage can be formed by lyophilizing an aqueous formulation of the TFPI or TFPI variant having a pH from about 4 to about 8 with a carbohydrate or amino acid glass forming agent. These lyophilized compositions are stable for greater than three months when stored at 40° C.
摘要翻译：通过用碳水化合物或氨基酸玻璃形成剂将具有pH约4至约8的TFPI或TFPI变体的水性制剂冻干，可以形成适于长期储存的TFPI或TFPI变体的冻干组合物。这些冻干组合物在40℃下储存时稳定3个月以上

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