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1. 发明授权

US5643566A Formulation processes for lipophilic proteins 失效
标题翻译：亲脂性蛋白质的配方
公开(公告)号：US5643566A
公开(公告)日：1997-07-01
申请号：US474769
申请日：1995-06-07
申请人： Wolfgang H. Hanisch , Pete M. Fernandes , Terrance Taforo , James W. Thomson
发明人： Wolfgang H. Hanisch , Pete M. Fernandes , Terrance Taforo , James W. Thomson
IPC分类号： A61K38/00 , C07K14/55 , C07K14/565 , A61K38/20 , A61K38/21
CPC分类号： C07K14/55 , C07K14/565 , A61K38/00
摘要： Highly stable, pharmaceutical compositions comprising a therapeutically effective amount of a biologically active recombinant lipophilic protein such as human .beta.-interferon and interleukin-2 dissolved in a non-toxic, inert, therapeutically compatible aqueous-based carrier at pH ranges of from about 6.8 to 7.8 and about 8.5 to 10, which formulations contain a stabilizer for the protein selected from the group comprising human serum album, human serum albumin and dextrose or human plasma protein fraction, and at a pH range of from about 2 to 4, which latter formulations optionally contain a carbohydrate and/or protein stabilizer, are disclosed. Further, preferred formulation processes to prepare said compositions are described which avoid highly alkaline conditions.
摘要翻译：高度稳定的药物组合物，其包含治疗有效量的生物活性重组亲脂蛋白，例如溶解在无毒，惰性，治疗上相容的水基载体中的人β-干扰素和白细胞介素-2，pH范围为约6.8至 7.8和约8.5至10，所述制剂含有选自包含人血清相册，人血清白蛋白和葡萄糖或人血浆蛋白质级分的蛋白质的稳定剂，并且在约2至4的pH范围内，后一种制剂任选地含有碳水化合物和/或蛋白质稳定剂。此外，描述了制备所述组合物的优选制剂方法，其避免高碱性条件。

2. 发明授权

US4992271A Formulation for lipophilic IL-2 proteins 失效
标题翻译：亲脂性IL-2蛋白的制剂
公开(公告)号：US4992271A
公开(公告)日：1991-02-12
申请号：US775751
申请日：1985-09-13
申请人： Wolfgang H. Hanisch , Peter M. Fernandes , Terrance Taforo
发明人： Wolfgang H. Hanisch , Peter M. Fernandes , Terrance Taforo
IPC分类号： C12P21/02 , A61K38/00 , A61K38/21 , A61K47/00 , A61K47/36 , A61K47/42 , A61P43/00 , C07K1/113 , C07K14/55 , C07K14/565
CPC分类号： C07K1/1136 , C07K14/55 , C07K14/565 , A61K38/00 , Y10S435/811 , Y10S514/885 , Y10S514/97
摘要： An improved process for recovering and purifying lipophilic recombinant proteins such as human .beta.-interferon and interleukin-2 from their hosts yields a protein preparation which may be formulated into a stable pharmaceutical composition having a therapeutically effective amount of the biologically active recombinant lipophilic protein dissolved in a non-toxic, inert, therapeutically compatible aqueous-based carrier medium at a pH of 6.8 to 7.8 which medium also contains a stabilizer for the protein, such as human serum albumin, normal serum albumin and human plasma protein fraction.
摘要翻译：从其宿主中回收和纯化亲脂性重组蛋白如人β-干扰素和白细胞介素-2的改进方法产生蛋白质制剂，其可以配制成具有治疗有效量的生物活性重组亲脂性蛋白质溶解于其中的稳定药物组合物一种无毒，惰性，治疗上相容的水性载体介质，pH 6.8至7.8，该介质还含有蛋白质稳定剂，如人血清白蛋白，正常血清白蛋白和人血浆蛋白质级分。

3. 发明授权

US4894439A N-terminal derivatives of tumor necrosis factor purified by microporous PTFE membranes 失效
标题翻译：通过微孔PTFE膜纯化的肿瘤坏死因子的N-末端衍生物
公开(公告)号：US4894439A
公开(公告)日：1990-01-16
申请号：US866213
申请日：1986-05-22
申请人： Glenn Dorin , Wolfgang H. Hanisch , James W. Thomson , Sidney N. Wolfe , Leo S. Lin
发明人： Glenn Dorin , Wolfgang H. Hanisch , James W. Thomson , Sidney N. Wolfe , Leo S. Lin
IPC分类号： C07K1/36 , C07K14/525
CPC分类号： C07K14/525 , C07K1/36 , Y10S530/82 , Y10S530/825
摘要： A process is disclosed for the purification of recombinantly produced biologically active proteins in which a solution containing a mixture of materials, including the biologically active protein, is passed through a continuous porous hydrophobic membrane, and the fraction enriched in the biologically active protein is recovered. Hydrophobic proteins such as TNF and recombinant ricin toxin A chain may be purified according to the process. Conditions for enhanced recovery of purified TNF using the process are disclosed. A highly purified TNF comprising 95% or greater TNF as determined by SDS-PAGE analysis, with an endotoxin content of less than 0.1 ng/mg TNF which is substantially free of pyrogens by the USP rabbit pyrogen test at a dosage range of 1.0 to 2.4.times.10.sup.5 U/kg, is obtained.
摘要翻译：公开了用于纯化重组产生的生物活性蛋白质的方法，其中将含有包含生物活性蛋白质的材料混合物的溶液通过连续的多孔疏水膜，并回收富含生物活性蛋白质的级分。疏水蛋白如TNF和重组蓖麻毒素A链可以根据该过程进行纯化。公开了使用该方法增强纯化的TNF的回收的条件。通过SDS-PAGE分析测定的包含95％或更高的TNF的高度纯化的TNF，其内毒素含量小于0.1ng / mg TNF，其通过USP兔热原测试在1.0至2.4的剂量范围内基本上不含热原 x105 U / kg。

4. 发明授权

US4748234A Process for recovering refractile bodies containing heterologous proteins from microbial hosts 失效
$Process for recovering refractile bodies containing heterologous proteins from microbial hosts$
标题翻译：从微生物宿主回收含有异源蛋白质的折射体的方法
公开(公告)号：US4748234A
公开(公告)日：1988-05-31
申请号：US843997
申请日：1986-03-25
申请人： Glenn Dorin , Wolfgang H. Hanisch , Leo S. Lin
发明人： Glenn Dorin , Wolfgang H. Hanisch , Leo S. Lin
IPC分类号： C12P21/00 , C07K1/113 , C07K1/14 , C07K1/36 , C07K14/52 , C07K14/54 , C07K14/55 , C07K14/555 , C07K14/565 , C12N15/09 , C12P21/02 , C12R1/19 , C07K3/12 , A61K45/02 , C07K3/28
CPC分类号： C07K1/1133 , C07K1/36 , C07K14/55 , C07K14/565 , Y10S530/825
摘要： A refractile material containing a heterologous protein is recovered from a host microorganism cell culture transformed to produce the protein. One recovery process involves disrupting the cell wall and membrane of the host cell, removing greater than 99% by weight of the salts from the disruptate, redisrupting the desalted disruptate, adding a material to the disruptate to create a density or viscosity gradient in the liquid within the disruptate, and separating the refractile material from the cellular debris by high-speed centrifugation. Another version of such a recovery process comprises the further steps of solubilizing the refractile material under reducing conditions, organically extracting the solubilized refractile material, and isolating said refractile material from the extractant.Preferably the protein is recombinant IL-2 or IFN-.beta. and the salt removal step is carried out by diafiltration.
摘要翻译：从转化以产生蛋白质的宿主微生物细胞培养物中回收含有异源蛋白质的折射材料。一个回收方法包括破坏宿主细胞的细胞壁和膜，从破坏的物质中除去大于99重量％的盐，重新破坏脱盐的破坏物，向破碎物中加入材料以在液体中产生密度或粘度梯度在破碎之内，并通过高速离心从细胞碎片中分离折射材料。这种回收方法的另一个方法包括在还原条件下增溶折射材料，有机萃取溶解的折射材料以及从萃取剂中分离所述折射材料的其它步骤。优选地，蛋白质是重组IL-2或IFN-β，并且通过渗滤进行除盐步骤。

5. 发明授权

US06637430B1 Respiratory delivery system with power/medicament recharge assembly 失效
标题翻译：带动力/药物补给装置的呼吸输送系统
公开(公告)号：US06637430B1
公开(公告)日：2003-10-28
申请号：US09595722
申请日：2000-06-16
申请人： Robert M. Voges , Wolfgang H. Hanisch , Olaf Reinhold
发明人： Robert M. Voges , Wolfgang H. Hanisch , Olaf Reinhold
IPC分类号： A61M1100
CPC分类号： A61M15/0065 , A61M15/008 , A61M15/025 , A61M2205/3553 , A61M2205/3584 , A61M2205/52
摘要： A respiratory delivery system is disclosed which preferably includes both medicament and plower recharge capabilities. The system includes a portable inhaler with a rechargeable medicament cartridge and a rechargeable power supply. This power supply may be electrically interconnected with one or more components of the portable inhaler, including a droplet ejection device, a controller for the droplet ejection device, an actuation switch, an inhalation sensor, and/or an electronic memory. The system further includes a recharging unit which includes an inhaler docking station, a medicament recharging system, and a power recharging system. When the portable inhaler is docked to the recharging unit, the recharging unit recharges the power supply of the portable inhaler and recharges the medicament cartridge of the portable inhaler by providing additional medicament thereto.
摘要翻译：公开了一种呼吸递送系统，其优选地包括药物和犁再充电能力。该系统包括具有可充电药剂盒和可充电电源的便携式吸入器。该电源可以与便携式吸入器的一个或多个部件电互连，包括液滴喷射装置，用于液滴喷射装置的控制器，致动开关，吸入传感器和/或电子存储器。该系统还包括一个充电单元，其包括一个吸入器对接站，一个药物充电系统和一个充电系统。当便携式吸入器对接到充电单元时，再充电单元对便携式吸入器的电源进行再充电，并通过向便携式吸入器提供附加的药剂来对便携式吸入器的药剂盒进行充电。

6. 发明授权

US4462940A Process for the recovery of human .beta.-interferon-like polypeptides 失效
标题翻译：回收人β-干扰素样多肽的方法
公开(公告)号：US4462940A
公开(公告)日：1984-07-31
申请号：US495896
申请日：1983-05-18
申请人： Wolfgang H. Hanisch , Peter M. Fernandes
发明人： Wolfgang H. Hanisch , Peter M. Fernandes
IPC分类号： A61K38/00 , C07K1/113 , C07K14/55 , C07K14/565 , C07G7/00 , A61K45/02
CPC分类号： C07K14/55 , C07K1/1136 , C07K14/565 , A61K38/00 , Y10S435/811 , Y10S530/808 , Y10S530/825
摘要： An improved process for recovering and purifying .beta.-HIFN from transformed bacterial comprising concentrating the bacteria; disrupting the cell wall and solubilizing the .beta.-HIFN into an aqueous medium with an appropriate solubilizing agent; extracting the .beta.-HIFN from the aqueous medium with 2-butanol, 2-methyl-2-butanol or mixtures thereof; precipitating and isolating the .beta.-HIFN from the alcohol phase; purifying the .beta.-HIFN by chromatography and diafiltering the .beta.-HIFN against distilled water or aqueous solutions of ethanol or glycerol at a pH of about 12; and therapeutic formulations and compositions of .beta.-HIFN within SDS levels therein reduced to less than 10 p.p.m.
摘要翻译：一种从转化细菌中回收和纯化β-HIFN的改进方法，包括浓缩细菌; 破坏细胞壁并用适当的增溶剂将β-HIFN溶解在水性介质中; 用2-丁醇，2-甲基-2-丁醇或其混合物从含水介质中提取β-HIFN; 从乙醇相中沉淀和分离β-HIFN; 通过色谱法纯化β-HIFN，并在pH约为12的情况下对蒸馏水或乙醇或甘油水溶液进行β-HIFN过滤; 并且其中SDS水平中的β-HIFN的治疗制剂和组合物降低至小于10p.p.m。

7. 发明授权

US5702699A Process for the recovery of lipophilic proteins 失效
标题翻译：回收亲脂性蛋白质的方法
公开(公告)号：US5702699A
公开(公告)日：1997-12-30
申请号：US474768
申请日：1995-06-07
申请人： Wolfgang H. Hanisch , Peter Fernandes
发明人： Wolfgang H. Hanisch , Peter Fernandes
IPC分类号： A61K38/00 , C07K14/565 , A61K38/21
CPC分类号： C07K14/565 , A61K38/00
摘要： An improved process for recovering and purifying lipophilic recombinant proteins such as human .beta.-interferon from their hosts involves concentrating the bacteria; disrupting the cell wall and solubilizing the protein into an aqueous medium with an appropriate solubilizing agent; extracting the protein from the aqueous medium with 2-butanol, 2-methyl-2-butanol or mixtures thereof; precipitating and isolating the protein from the alcohol phase; purifying the protein by chromatography and diafiltering the protein against distilled water or aqueous solutions of ethanol or glycerol at a pH of about 12. Therapeutic formulations of such purified proteins with stabilizers contain SDS levels reduced to less than 10 p.p.m.
摘要翻译：从其宿主中回收和纯化亲脂性重组蛋白如人β-干扰素的改进方法包括浓缩细菌; 破坏细胞壁并用合适的增溶剂将蛋白质溶解在含水介质中; 用2-丁醇，2-甲基-2-丁醇或其混合物从含水介质中提取蛋白质; 从醇相中沉淀和分离蛋白质; 通过色谱法纯化蛋白质，并在约12的pH下将蒸馏水或乙醇或甘油水溶液过滤到蛋白质。具有稳定剂的这种纯化蛋白质的治疗制剂含有降低至低于10p.p.m的SDS水平。

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