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1. 发明申请

US20120135928A1 METHOD FOR PURIFYING RECOMBINANT FSH 有权
标题翻译：净化重组FSH的方法
公开(公告)号：US20120135928A1
公开(公告)日：2012-05-31
申请号：US13262622
申请日：2010-04-01
申请人： Christian Scheckermann , Dietmar Eichinger , Stefan Arnold
发明人： Christian Scheckermann , Dietmar Eichinger , Stefan Arnold
IPC分类号： A61K38/24 , A61P15/08 , C07K14/59 , C07K1/36 , B01D15/38
CPC分类号： C07K14/59 , A61K38/00 , C07K1/36 , C12P21/005
摘要： The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or re-combinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.
摘要翻译：本发明涉及一种纯化重组卵泡刺激素（FSH）或重组FSH变体的方法。该方法包括以下步骤：将含有重组FSH或重组FSH变体的液体进行阴离子交换层析，到疏水相互作用色谱法和染料亲和层析，其中这些色谱可以以任何顺序进行，并且其中所述方法既不包括弱阴离子交换色谱法也不包括反相色谱法。纯化的方法导致具有所需纯度的重组FSH的高产率。获得的FSH对于预防和治疗疾病和医疗适应症尤其有用，其中FSH制剂被认为是有用的补救措施。

2. 发明授权

US09096683B2 Method for purifying recombinant FSH 有权
标题翻译：重组FSH的纯化方法
公开(公告)号：US09096683B2
公开(公告)日：2015-08-04
申请号：US13262622
申请日：2010-04-01
申请人： Christian Scheckermann , Dietmar Eichinger , Stefan Arnold
发明人： Christian Scheckermann , Dietmar Eichinger , Stefan Arnold
IPC分类号： A61K38/24 , A61P15/08 , C07K1/36 , C07K14/59
CPC分类号： C07K14/59 , A61K38/00 , C07K1/36 , C12P21/005
摘要： The present invention relates to a method for purifying a recombinant follicle stimulating hormone (FSH) or recombinant FSH variant. The method comprises the steps of subjecting a liquid containing a recombinant FSH or recombinant FSH variant to an anion exchange chromatography, to a hydrophobic interaction chromatography, and to a dye affinity chromatography, wherein these chromatographies may be performed in any order, and wherein the method neither comprises a weak anion exchange chromatography nor a reverse phase chromatography. The method of purification results in a high yield of recombinant FSH having a desired degree of purity. The obtained FSH is especially useful for the prophylaxis and treatment of disorders and medical indications where FSH preparations are considered as useful remedies.
摘要翻译：本发明涉及纯化重组卵泡刺激素（FSH）或重组FSH变体的方法。该方法包括以下步骤：将含有重组FSH或重组FSH变体的液体进行阴离子交换层析，到疏水相互作用层析和染料亲和层析，其中这些色谱可以以任何顺序进行，并且其中所述方法既不包括弱阴离子交换色谱法也不包括反相色谱法。纯化的方法导致具有所需纯度的重组FSH的高产率。获得的FSH对于预防和治疗疾病和医疗适应症尤其有用，其中FSH制剂被认为是有用的补救措施。

3. 发明申请

US20120177603A1 METHOD FOR THE PURIFICATION OF INTERFERON-B 审中-公开
标题翻译：干扰素B的纯化方法
公开(公告)号：US20120177603A1
公开(公告)日：2012-07-12
申请号：US13382807
申请日：2010-07-07
申请人： Stefan Arnold , Christian Scheckermann
发明人： Stefan Arnold , Christian Scheckermann
IPC分类号： A61K38/21 , C07K14/565
CPC分类号： C07K14/565 , A61K9/0019 , A61K38/00
摘要： A method for the production of human glycosylated Interferon-beta (IFN-β) is described, comprising two affinity chromatography steps followed by hydrophobic interaction chromatography step preferably with a subsequent anion exchange chromatography step. IFN-β obtained by the method as described is characterized by a high purity and specific biologically activity, because of which it is particularly suitable for the production of pharmaceutical compositions.
摘要翻译：描述了用于生产人糖基化干扰素-β（IFN-α）的方法，其包括两个亲和层析步骤，随后是疏水相互作用层析步骤，优选随后进行阴离子交换层析步骤。 IFN-和bgr 通过所述方法获得的特征在于高纯度和特异性的生物活性，因为它特别适用于制备药物组合物。

4. 发明申请

US20120328560A1 METHOD FOR OBTAINING BIOLOGICALLY ACTIVE RECOMBINANT HUMAN G-CSF 有权
标题翻译：获得生物活性重组人G-CSF的方法
公开(公告)号：US20120328560A1
公开(公告)日：2012-12-27
申请号：US13634801
申请日：2011-03-17
申请人： Walter Hinderer , Christian Scheckermann
发明人： Walter Hinderer , Christian Scheckermann
IPC分类号： C07K1/20 , A61K38/19 , C07K14/535
CPC分类号： C07K14/535
摘要： Provided is a method of obtaining biologically active recombinant human G-CSF from inclusion bodies, wherein the solubilization and refolding process can be performed at ambient temperature and the purification step comprises reversed phase chromatography (RP), in particular RP-HPLC. The G-CSF preparation so obtained is characterized by high purity and homogeneity.
摘要翻译：提供从包涵体获得生物活性重组人G-CSF的方法，其中可以在环境温度下进行溶解和重折叠过程，并且纯化步骤包括反相色谱（RP），特别是RP-HPLC。如此获得的G-CSF制剂的特征在于高纯度和均匀性。

5. 发明授权

US08546328B2 Liquid formulation of G-CSF conjugate 有权
标题翻译： G-CSF缀合物的液体制剂
公开(公告)号：US08546328B2
公开(公告)日：2013-10-01
申请号：US12675749
申请日：2008-08-27
申请人： Walter Hinderer , Christian Scheckermann
发明人： Walter Hinderer , Christian Scheckermann
IPC分类号： A61K38/19 , C07K14/53 , C07K1/107 , A61M5/178 , A61M5/28 , A61M5/32 , A61J1/00
CPC分类号： A61K47/60
摘要： The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer, the composition having a pH value in the range of 4.5 to 5.5. The composition further comprises a surfactant and optionally one or more other pharmaceutically acceptable excipients. Further, the composition of the invention is free from tartaric acid or salts thereof and from succinic acid and salts thereof as buffering agents and does not contain amino acids as stabilizer. The composition has a good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.
摘要翻译：本发明涉及包含与聚合物缀合的粒细胞集落刺激因子多肽的液体药物组合物，所述组合物的pH值在4.5至5.5的范围内。组合物还包含表面活性剂和任选的一种或多种其它药学上可接受的赋形剂。此外，本发明的组合物不含酒石酸或其盐，琥珀酸及其盐作为缓冲剂，不含氨基酸作为稳定剂。该组合物具有良好的储存稳定性，并且特别可用于预防和治疗疾病和医学适应症，其中将粒细胞集落刺激因子制剂视为有用的治疗方法。

6. 发明申请

US20140057316A1 METHOD OF PRODUCING AND PURIFYING AN ACTIVE SOLUBLE SIALYLTRANSFERASE 有权
标题翻译：生产和净化活性可溶性硅藻土的方法
公开(公告)号：US20140057316A1
公开(公告)日：2014-02-27
申请号：US13813804
申请日：2011-02-02
申请人： Axel Angermann , Christian Scheckermann , Karsten Schmidt
发明人： Axel Angermann , Christian Scheckermann , Karsten Schmidt
IPC分类号： C12N9/10
CPC分类号： C12N9/1081 , C12Y204/99003
摘要： The present invention relates to a method for the production and purification of a sialyltransferase polypeptide, in particular a N-Acetylgalactosamine (Gal NAc)-α-2,6-sialyltransferase I (ST6GalNAcI) polypeptide. The method comprises the steps of producing the sialyltransferase polypeptide in a Chinese Hamster Ovary (CHO) cell and purifying the polypeptide with a combination of chromatography steps. The method results in high yield of sialyltransferase polypeptide which is highly pure and active. The obtained sialyltransferase, especially ST6GalNAcI, can be employed for the glycosylation of therapeutic proteins such as G-CSF.
摘要翻译：本发明涉及生产和纯化唾液酸转移酶多肽，特别是N-乙酰半乳糖胺（Gal NAc）-al-2,6-sialyltransferase I（ST6GalNAcI）多肽的方法。该方法包括在中国仓鼠卵巢（CHO）细胞中产生唾液酸转移酶多肽的步骤，并用色谱步骤的组合纯化多肽。该方法导致高纯度和活性的唾液酸转移酶多肽的高产量。获得的唾液酸转移酶，特别是ST6GalNAcI可用于治疗性蛋白质如G-CSF的糖基化。

7. 发明授权

US08207112B2 Liquid formulation of G-CSF conjugate 有权
标题翻译： G-CSF缀合物的液体制剂
公开(公告)号：US08207112B2
公开(公告)日：2012-06-26
申请号：US12201705
申请日：2008-08-29
申请人： Walter Hinderer , Christian Scheckermann
发明人： Walter Hinderer , Christian Scheckermann
IPC分类号： A61K38/18 , A61K38/00 , C07K14/475 , A61P7/00 , A61P7/06
CPC分类号： A61K38/193 , A61K9/0019 , A61K47/10
摘要： The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer. In various embodiments, the composition has a pH value in the range of 4.5 to 5.5. Exemplary compositions further comprise a surfactant and optionally one or more other pharmaceutically acceptable excipients. The invention provides, inter alia, formulations free from tartaric acid or salts thereof and/or from succinic acid and salts thereof as buffering agents. Exemplary formulations are essentially devoid of not amino acids as stabilizers. The composition has good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.
摘要翻译：本发明涉及包含与聚合物缀合的粒细胞集落刺激因子多肽的液体药物组合物。在各种实施方案中，组合物的pH值在4.5至5.5的范围内。示例性组合物还包含表面活性剂和任选的一种或多种其它药学上可接受的赋形剂。本发明尤其提供了不含酒石酸或其盐和/或琥珀酸及其盐作为缓冲剂的制剂。示例性制剂基本上不含氨基酸作为稳定剂。该组合物具有良好的储存稳定性，并且特别可用于预防和治疗疾病和医学适应症，其中将粒细胞集落刺激因子制剂视为有用的治疗方法。

8. 发明申请

US20110053844A1 LIQUID FORMULATION OF G-CSF CONJUGATE 有权
标题翻译： G-CSF凝血液的液体配方
公开(公告)号：US20110053844A1
公开(公告)日：2011-03-03
申请号：US12675749
申请日：2008-08-27
申请人： Walter Hinderer , Christian Scheckermann
发明人： Walter Hinderer , Christian Scheckermann
IPC分类号： A61K38/22 , A61P25/00 , A61P43/00 , A61M5/32 , A61M5/178 , A61J1/05
CPC分类号： A61K47/60
摘要： The present invention relates to a liquid pharmaceutical composition comprising a granulocyte colony stimulating factor polypeptide conjugated with a polymer, the composition having a pH value in the range of 4.5 to 5.5. The composition further comprises a surfactant and optionally one or more other pharmaceutically acceptable excipients. Further, the composition of the invention is free from tartaric acid or salts thereof and from succinic acid and salts thereof as buffering agents and does not contain amino acids as stabilizer. The composition has a good storage stability and is especially useful for the prophylaxis and treatment of disorders and medical indications where granulocyte colony stimulating factor preparations are considered as useful remedies.
摘要翻译：本发明涉及包含与聚合物缀合的粒细胞集落刺激因子多肽的液体药物组合物，所述组合物的pH值在4.5至5.5的范围内。组合物还包含表面活性剂和任选的一种或多种其它药学上可接受的赋形剂。此外，本发明的组合物不含酒石酸或其盐，琥珀酸及其盐作为缓冲剂，不含氨基酸作为稳定剂。该组合物具有良好的储存稳定性，并且特别可用于预防和治疗疾病和医学适应症，其中将粒细胞集落刺激因子制剂视为有用的治疗方法。

9. 发明授权

US09222081B2 Method of producing and purifying an active soluble sialyltransferase 有权
标题翻译：生产和纯化活性可溶性唾液酸转移酶的方法
公开(公告)号：US09222081B2
公开(公告)日：2015-12-29
申请号：US13813804
申请日：2011-08-02
申请人： Axel Angermann , Christian Scheckermann , Karsten Schmidt
发明人： Axel Angermann , Christian Scheckermann , Karsten Schmidt
IPC分类号： C12P21/06 , C12N9/10
CPC分类号： C12N9/1081 , C12Y204/99003
摘要： The present invention relates to a method for the production and purification of a sialyltransferase polypeptide, in particular a N-Acetylgalactosamine (Gal NAc)-α-2,6-sialyltransferase I (ST6GalNAcI) polypeptide. The method comprises the steps of producing the sialyltransferase polypeptide in a Chinese Hamster Ovary (CHO) cell and purifying the polypeptide with a combination of chromatography steps. The method results in high yield of sialyltransferase polypeptide which is highly pure and active. The obtained sialyltransferase, especially ST6GalNAcI, can be employed for the glycosylation of therapeutic proteins such as G-CSF.
摘要翻译：本发明涉及唾液酸转移酶多肽，特别是N-乙酰半乳糖胺（Gal NAc）-α-2,6-唾液酸转移酶I（ST6GalNAcI）多肽的生产和纯化方法。该方法包括在中国仓鼠卵巢（CHO）细胞中产生唾液酸转移酶多肽的步骤，并用色谱步骤的组合纯化多肽。该方法导致高纯度和活性的唾液酸转移酶多肽的高产量。获得的唾液酸转移酶，特别是ST6GalNAcI可用于治疗性蛋白质如G-CSF的糖基化。

10. 发明授权

US08703123B2 Method for obtaining biologically active recombinant human G-CSF 有权
标题翻译：获得生物活性重组人G-CSF的方法
公开(公告)号：US08703123B2
公开(公告)日：2014-04-22
申请号：US13634801
申请日：2011-03-17
申请人： Walter Hinderer , Christian Scheckermann
发明人： Walter Hinderer , Christian Scheckermann
IPC分类号： A61K35/00 , C07K1/16 , C07K1/18 , C07K1/20
CPC分类号： C07K14/535
摘要： Provided is a method of obtaining biologically active recombinant human G-CSF from inclusion bodies, wherein the solubilization and refolding process can be performed at ambient temperature and the purification step comprises reversed phase chromatography (RP), in particular RP-HPLC. The G-CSF preparation so obtained is characterized by high purity and homogeneity.
摘要翻译：提供从包涵体获得生物活性重组人G-CSF的方法，其中可以在环境温度下进行溶解和重折叠过程，并且纯化步骤包括反相色谱（RP），特别是RP-HPLC。如此获得的G-CSF制剂的特征在于高纯度和均匀性。

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