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1. 发明授权

EP2379108B1 IMMUNOGLOBULIN PURIFICATION 有权
标题翻译：免疫球蛋白清洁
公开(公告)号：EP2379108B1
公开(公告)日：2014-06-25
申请号：EP09796320.1
申请日：2009-12-18
申请人： F. Hoffmann-La Roche AG
发明人： POMPIATI, Marc , SCHAUBMAR, Andreas
IPC分类号： A61K39/395 , C07K16/06 , C07K1/18
CPC分类号： C07K16/065 , A61K39/39591 , C07K1/18 , C07K16/2803 , C07K16/2866

2. 发明授权

EP1830889B1 CONJUGATES OF INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) AND POLY(ETHYLENE GLYCOL) 有权
标题翻译：胰岛素样生长因子-1（IGF-1）和聚（乙二醇）的共轭物
公开(公告)号：EP1830889B1
公开(公告)日：2017-05-17
申请号：EP05849990.6
申请日：2005-12-21
申请人： F. Hoffmann-La Roche AG
发明人： AMREIN, Beat , FOSER, Stefan , LANG, Kurt , METZGER, Friedrich , REGULA, Jörg , SCHAUBMAR, Andreas , HESSE, Friederike , KUENKELE, Klaus-Peter , LANZENDOERFER,Martin
IPC分类号： A61K47/60 , A61P25/28
CPC分类号： A61K47/60 , C07K14/475 , C07K14/65
摘要： A conjugate consisting of an insulin-like growth factor-1 (IGF-I) variant and one or two poly(ethylene glycol) group(s), characterized in that said IGF-I variant has an amino acid alteration at up to three amino acid positions 27, 37, 65, 68 of the wild-type IGF-I amino acid sequence so that one or two of said amino acids is/are lysine and amino acid 27 is a polar aminio acid but not lysine, is conjugated via the primary amino group(s) of said lysine(s) and said poly(ethylene glycol) group(s) have an overall molecular weight of from 20 to 100 kDa is disclosed. This conjugate is useful for the treatment of neurodegenerative disorders like Alzheimer's Disease.
摘要翻译：由胰岛素样生长因子-1（IGF-1）变体和一个或两个聚（乙二醇）基团组成的缀合物，其特征在于所述IGF-1变体具有至多三个氨基的氨基酸改变野生型IGF-I氨基酸序列的氨基酸位置27,37,65,68使得所述氨基酸中的一个或两个氨基酸是赖氨酸且氨基酸27是极性氨基酸但不是赖氨酸通过公开了所述赖氨酸和所述聚（乙二醇）基团的一个或多个伯氨基具有20至100kDa的总分子量。该缀合物对于治疗神经退行性疾病如阿尔茨海默病是有用的。

3. 发明公开

EP3036253A1 SEPARATION OF BISPECIFIC ANTIBODIES AND BISPECIFIC ANTIBODY PRODUCTION SIDE PRODUCTS USING HYDROXYAPATITE CHROMATOGRAPHY 有权
标题翻译：双特异性抗体和副产品从生产双特异性抗体BY HYDROXYAPATITCHROMATOGRAFIE分离
公开(公告)号：EP3036253A1
公开(公告)日：2016-06-29
申请号：EP14761965.4
申请日：2014-08-18
申请人： F. Hoffmann-La Roche AG
发明人： BERTL, Sabine , DUERR, Harald , SCHAUBMAR, Andreas
IPC分类号： C07K16/00 , C07K1/16 , C07K16/46 , C07K16/28 , C07K16/22 , C07K16/24
摘要： The present invention is directed to methods comprising the use of hydroxyapatite chromatography to separate a bispecific antibody from a solution that also comprises one or more byproducts specific to bispecific antibody production. Byproducts specific to the production of bispecific antibodies (bispecific antibody specific byproducts, “BASB”) include fragments of the bispecific antibody and heavier molecular weight variants of the antibody, wherein the fragment and/or variant comprises an Fc domain but does not exhibit affinity for the two different epitopes and/or antigens as exhibited by the desired bispecific antibody. Thus, the methods of the present invention comprise the separation of a bispecific antibody from one or more of its BASB. The hydroxyapatite chromatography methods of the invention may be used alone or may be further combined with standard purification processes and unit operations as is known in the art to achieve any level of purity of bispecific antibody necessary, e.g., for therapeutic and/or diagnostic applications.
摘要翻译：本发明涉及包括使用羟基磷灰石层析，以从溶液中分离的双特异性抗体的方法这样做是包括一个或多个特定的副产物双特异性抗体的产生。具体的生产双特异性抗体的副产物（双特异性抗体特异性副产物，“BASB”）包括与双特异性抗体的片段和该抗体的较重分子量的变体，worin片段/或变体Fc结构域包括，但不表现出亲合性的两个不同表位和/或作为展出由期望双特异性抗体的抗原。因此，本发明的方法包括从一个或多个其BASB的双特异性抗体的分离。本发明的羟基磷灰石层析方法可以单独使用，也可以与标准的纯化方法和单元操作，如本领域中已知的，以实现双特异性抗体的必要，E. G.，用于治疗和/或诊断应用中的任何纯度水平进一步组合。

4. 发明授权

EP2274624B1 PEGYLATED INSULIN-LIKE-GROWTH-FACTOR ASSAY 有权
标题翻译： PEG化的胰岛素样生长因子测定法
公开(公告)号：EP2274624B1
公开(公告)日：2011-11-09
申请号：EP09726947.6
申请日：2009-03-31
申请人： F. Hoffmann-La Roche AG
发明人： LANG, Kurt , SCHAUBMAR, Andreas , SCHLEYPEN, Julia , SCHLOTHAUER, Tilman
IPC分类号： G01N33/74 , G01N33/543 , G01N33/58
CPC分类号： G01N33/566 , G01N33/74 , G01N2333/65
摘要： The current invention reports an immunoassay for the determination of PEGylated insulin-like-growth-factor employing an anti-(polyethylene glycol) antibody and an anti-digoxygenin antibody for the detection of an insulin-like-growth- factor/insulin-like-growth-factor-binding-protein-complex.
摘要翻译：本发明报道了使用抗（聚乙二醇）抗体和抗洋地黄毒苷抗体用于检测胰岛素样生长因子/胰岛素样生长因子的聚乙二醇化胰岛素样生长因子的免疫测定法，生长因子结合蛋白复合体。

5. 发明公开

EP1830889A2 CONJUGATES OF INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) AND POLY(ETHYLENE GLYCOL) 有权
标题翻译： KONJUGATE VONINSULINÄHNLICHEMWACHSTUMSFAKTOR-1（IGF-1）UND POLY（ETHYLINGLYKOL）
公开(公告)号：EP1830889A2
公开(公告)日：2007-09-12
申请号：EP05849990.6
申请日：2005-12-21
申请人： F. HOFFMANN-LA ROCHE AG
发明人： AMREIN, Beat , FOSER, Stefan , LANG, Kurt , METZGER, Friedrich , REGULA, Jörg , SCHAUBMAR, Andreas , HESSE, Friederike , KUENKELE, Klaus-Peter , LANZENDOERFER,Martin
IPC分类号： A61K47/48
CPC分类号： A61K47/60 , C07K14/475 , C07K14/65
摘要： A conjugate consisting of an insulin-like growth factor-1 (IGF-I) variant and one or two poly(ethylene glycol) group(s), characterized in that said IGF-I variant has an amino acid alteration at up to three amino acid positions 27, 37, 65, 68 of the wild-type IGF-I amino acid sequence so that one or two of said amino acids is/are lysine and amino acid 27 is a polar aminio acid but not lysine, is conjugated via the primary amino group(s) of said lysine(s) and said poly(ethylene glycol) group(s) have an overall molecular weight of from 20 to 100 kDa is disclosed. This conjugate is useful for the treatment of neurodegenerative disorders like Alzheimer's Disease.
摘要翻译：由胰岛素样生长因子-1（IGF-I）变体和一个或两个聚（乙二醇）基团组成的缀合物，其特征在于所述IGF-1变体在最多三个氨基酸处具有氨基酸改变野生型IGF-I氨基酸序列的酸位置27,37,65,68，使得一个或两个所述氨基酸是赖氨酸，氨基酸27是极性氨基酸而不是赖氨酸，通过所述赖氨酸和所述聚（乙二醇）基团的伯氨基具有20至100kDa的总分子量。该缀合物可用于治疗神经变性疾病如阿尔茨海默病。

6. 发明公开

EP2274624A1 PEGYLATED INSULIN-LIKE-GROWTH-FACTOR ASSAY 有权
标题翻译：聚乙二醇化胰岛素样生长因子ASSAYS
公开(公告)号：EP2274624A1
公开(公告)日：2011-01-19
申请号：EP09726947.6
申请日：2009-03-31
申请人： F. Hoffmann-La Roche AG
发明人： LANG, Kurt , SCHAUBMAR, Andreas , SCHLEYPEN, Julia , SCHLOTHAUER, Tilman
IPC分类号： G01N33/74 , G01N33/543 , G01N33/58
CPC分类号： G01N33/566 , G01N33/74 , G01N2333/65
摘要： The current invention reports an immunoassay for the determination of PEGylated insulin-like-growth-factor employing an anti-(polyethylene glycol) antibody and an anti-digoxygenin antibody for the detection of an insulin-like-growth- factor/insulin-like-growth-factor-binding-protein-complex.

7. 发明公开

EP2245044A2 PURIFICATION OF NON-GLYCOSYLATED PROTEINS 审中-公开
标题翻译：清洁糖基化蛋白
公开(公告)号：EP2245044A2
公开(公告)日：2010-11-03
申请号：EP09702937.5
申请日：2009-01-15
申请人： F. Hoffmann-La Roche AG
发明人： FALKENSTEIN, Roberto , FLECKS, Birgit , GIESSEL, Claudia , GREITHANNER, Sybille , GROSSMANN, Adelbert , HESSE, Frederike , KRAEMER, Brigitte , POMPIATI, Marc , SCHAUBMAR, Andreas , WEIDLICH, Nicole
IPC分类号： C07K1/36 , C07K14/56
CPC分类号： C07K1/1077 , C07K1/16 , C07K1/18 , C07K1/20 , C07K1/22 , C07K1/36
摘要： The current invention reports a method for the purification of a not-glycosylated, heterologous polypeptide, which has been recombinantly produced in a prokaryotic cell, wherein the method comprises three chromatography steps of which the first chromatography step selected from i) hydrophobic charge induction chromatography, or ii) hydrophobic interaction chromatography, or iii) affinity chromatography, or iv) ion exchange chromatography, the second chromatography step is selected from i) anion exchange chromatography, or ii) cation exchange chromatography, or iii) hydroxylapatite chromatography, or iv) hydrophobic interaction chromatography, and the a third chromatography step is selected from i) hydrophobic charge induction chromatography, or ii) anion exchange chromatography, or iii) cation exchange chromatography, or iv) hydrophobic interaction chromatography, whereby the first chromatography step is an affinity chromatography in case of polypeptides capable of interacting with metal ligands, the second chromatography step is not a hydroxylapatite chromatography step in case of polypeptides with an isoelectric point below 6.0, and the third chromatography step can be performed in flow-through mode with polypeptides having a low or high isoelectric point.

8. 发明公开

EP4018453A1 CATION CHROMATOGRAPHY USING PREDICTED ELUTION BUFFER SALT CONCENTRATION 审中-实审
公开(公告)号：EP4018453A1
公开(公告)日：2022-06-29
申请号：EP20786452.1
申请日：2020-09-24
申请人： F. Hoffmann-La Roche AG
发明人： SCHAUBMAR, Andreas , WITTKOPP, Felix
IPC分类号： G16C20/30 , B01D15/36 , B01J47/02 , C07K1/18 , B01D15/16 , B01J39/07

9. 发明授权

EP3036253B1 SEPARATION OF BISPECIFIC ANTIBODIES AND BISPECIFIC ANTIBODY PRODUCTION SIDE PRODUCTS USING HYDROXYAPATITE CHROMATOGRAPHY 有权
公开(公告)号：EP3036253B1
公开(公告)日：2020-09-23
申请号：EP14761965.4
申请日：2014-08-18
申请人： F. Hoffmann-La Roche AG
发明人： BERTL, Sabine , DUERR, Harald , SCHAUBMAR, Andreas
IPC分类号： C07K16/00 , C07K1/16 , C07K16/46 , C07K16/28 , C07K16/22 , C07K16/24 , C07K1/18 , B01D15/36 , B01D15/38

10. 发明公开

EP2379108A1 IMMUNOGLOBULIN PURIFICATION 有权
标题翻译：免疫球蛋白清洁
公开(公告)号：EP2379108A1
公开(公告)日：2011-10-26
申请号：EP09796320.1
申请日：2009-12-18
申请人： F. Hoffmann-La Roche AG
发明人： POMPIATI, Marc , SCHAUBMAR, Andreas
IPC分类号： A61K39/395 , C07K16/06 , C07K1/18
CPC分类号： C07K16/065 , A61K39/39591 , C07K1/18 , C07K16/2803 , C07K16/2866
摘要： The current invention reports a method for purifying an immunoglobulin, wherein the method comprises applying an aqueous, buffered solution comprising an immunoglobulin in monomeric, in aggregated, and in fragmented form to an anion exchange chromatography material under conditions whereby the immunoglobulin in monomeric form does not bind to the anion exchange material, and recovering the immunoglobulin in monomeric form in the flow-through from the anion exchange chromatography material, whereby the buffered aqueous solution has a pH value of from 8.0 to 8.5. In one embodiment the anion exchange chromatography material is a membrane anion exchange chromatography material.

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