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1. 发明授权

US09359397B2 Method for manufacturing protein drug 有权
标题翻译：制造蛋白质药物的方法
公开(公告)号：US09359397B2
公开(公告)日：2016-06-07
申请号：US14127291
申请日：2012-06-22
申请人： Tomoko Hongo , Hirohisa Hayashida
发明人： Tomoko Hongo , Hirohisa Hayashida
IPC分类号： C07K1/34 , C07K16/00 , B01D61/14 , C07K16/06 , A61K38/00
CPC分类号： C07K1/34 , A61K38/00 , B01D61/14 , B01D2311/14 , B01D2311/18 , C07K16/00 , C07K16/065 , Y02A50/463
摘要： The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cm2 or lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0≦Y≦150X−590 (Equation 1) and 3.5≦X≦8.0 (Equation 5) or the following equations 4 and 5: Y=0 (Equation 4) and 3.5≦X≦8.0 (Equation 5).
摘要翻译：本发明提供一种无病毒蛋白质药物的制造方法，其特征在于，包括：（a）通过小孔径病毒去除膜过滤含病毒蛋白质溶液的过滤步骤，得到无病毒蛋白质溶液，过滤步骤（a）包括（q）在0.30kgf / cm 2以下的过滤压力下通过小孔径病毒去除膜过滤溶液的低压过滤步骤，以获得无病毒蛋白质溶液，其中溶液在低压过滤步骤（q）中过滤之前，具有满足以下等式1和5的pH（X）和盐离子强度（Y（mM））：0＆nlE; Y＆nlE; 150X-590（等式1）和3.5＆nlE; X＆nlE; 8.0（等式5）或下面的等式4和5：Y = 0（等式4）和3.5＆nlE; X＆nlE; 8.0（等式5）。

2. 发明授权

US6147114A Highly water-soluble metalloproteinase inhibitors 失效
标题翻译：高度水溶性金属蛋白酶抑制剂
公开(公告)号：US6147114A
公开(公告)日：2000-11-14
申请号：US945356
申请日：1997-10-24
申请人： Tetsunori Fujisawa , Shinjiro Odake , Yasuo Morita , Tomoko Hongo , Hajime Ito , Junko Yasuda , Eiko Suda , Katsuhiro Igeta , Tadanori Morikawa
发明人： Tetsunori Fujisawa , Shinjiro Odake , Yasuo Morita , Tomoko Hongo , Hajime Ito , Junko Yasuda , Eiko Suda , Katsuhiro Igeta , Tadanori Morikawa
IPC分类号： A61K31/165 , C07C239/06 , C07C259/06 , C07C279/14 , C07C279/16 , C07C305/24 , C07C309/61 , C07C323/60 , C07F9/12 , A01N37/28 , C07C239/14
CPC分类号： C07C323/60 , A61K31/165 , C07C239/06 , C07C259/06 , C07C279/14 , C07C279/16 , C07C305/24 , C07C309/61 , C07F9/12
摘要： New compounds of the general formula (I) ##STR1## (wherein R.sup.1 is a hydrogen atom, or a hydroxyl, aryl (C.sub.1 -C.sub.6)alkylene or --A--SOn--B group (A is a (C.sub.1 -C.sub.6) alkylene group; B is a (C.sub.1 -C.sub.6) alkyl, (C.sub.1 -C.sub.6) acyl, aryl or heterocyclyl group; n is 0, 1 or 2), R.sup.2 is a hydrogen atom, or a (C.sub.1 -C.sub.6) alkyl, (C.sub.1 -C.sub.6) alkyloxy 10 or (C.sub.1 -C.sub.6) alkylthio group, R.sup.3 and R.sup.4 are identical or different, representing a hydrogen atom, or a (C.sub.1 -C.sub.6) alkyl, aryl or aryl(C.sub.1 -C.sub.6)alkylene group, R.sup.5 is a --Y--C or C group (Y is a (C.sub.1 -C.sub.6) alkylene group, an oxygen atom, an imino group or a (C.sub.1 -C.sub.6) alkyleneimino group, C is a sulfonic acid, phosphonic acid, amidino, (C.sub.1 -C.sub.6) acyl, acylimidoyl, diphosphonomethine or dicarboxymethine group), and R.sup.6 is a hydrogen atom, or a nonsubstituted or substituted benzyl, trialkylsilyl, tert-butyldiphenylsilyl, tetrahydropyranyl or tert-butyl group) or stereoisomers thereof, and pharmaceutically acceptable salts thereof and solvates thereof, and the process for the preparation thereof, and metalloproteinase inhibitors which comprise one or more compounds selected from those compounds as effective ingredients and inhibit matrix metalloproteinases (MMPs) and/or TNF-.alpha. converting enzyme. Furthermore, the preparation intermediates to obtain the compounds of the formula (I) and the process for the preparation.
摘要翻译： PCT No.PCT / JP96 / 01135 Sec。 371 1997年10月24日第 102（e）1997年10月24日PCT PCT 1996年4月25日PCT公布。 WO96 / 33968 PCT公开号日期：1996年10月31日新化合物通式（Ⅰ）（其中R1是氢原子，或羟基，芳基（C1-C6）亚烷基或-A-SOn-B基团（A是（C1-C6）亚烷基; B是（C1-C6）烷基，（C1-C6）酰基，芳基或杂环基; n是0,1或2），R2是氢原子或（C1-C6）烷基， C1-C6）烷氧基10或（C1-C6）烷硫基，R3和R4相同或不同，代表氢原子或（C1-C6）烷基，芳基或芳基（C1-C6）亚烷基，R5是 -YC或C基（Y是（C1-C6）亚烷基，氧原子，亚氨基或（C1-C6）亚烷基亚氨基），C是磺酸，膦酸，脒基，（C1-C6 ）酰基，酰亚氨基，二亚膦酰基或二羧基甲基），R6为氢原子，或未取代或取代的苄基，三烷基甲硅烷基，叔丁基二苯基甲硅烷基，四氢吡喃基或叔丁基）或其立体异构体及其药学上可接受的盐及其溶剂合物，以及其准备过程 f和金属蛋白酶抑制剂，其包含一种或多种选自那些化合物的化合物作为有效成分并抑制基质金属蛋白酶（MMP）和/或TNF-α转化酶。此外，制备中间体以获得式（I）化合物及其制备方法。

3. 发明申请

US20140199262A1 METHOD FOR MANUFACTURING PROTEIN DRUG 有权
标题翻译：制备蛋白质药物的方法
公开(公告)号：US20140199262A1
公开(公告)日：2014-07-17
申请号：US14127291
申请日：2012-06-22
申请人： Tomoko Hongo , Hirohisa Hayashida
发明人： Tomoko Hongo , Hirohisa Hayashida
IPC分类号： C07K1/34 , C07K16/00
CPC分类号： C07K1/34 , A61K38/00 , B01D61/14 , B01D2311/14 , B01D2311/18 , C07K16/00 , C07K16/065 , Y02A50/463
摘要： The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cm2 or lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0≦Y≦150X−590 (Equation 1) and 3.5≦X≦8.0 (Equation 5) or the following equations 4 and 5: Y=0 (Equation 4) and 3.5≦X≦8.0 (Equation 5).
摘要翻译：本发明提供一种无病毒蛋白质药物的制造方法，其特征在于，包括：（a）通过小孔径病毒去除膜过滤含病毒蛋白质溶液的过滤步骤，得到无病毒蛋白质溶液，过滤步骤（a）包括（q）在0.30kgf / cm 2以下的过滤压力下通过小孔径病毒去除膜过滤溶液的低压过滤步骤，以获得无病毒蛋白质溶液，其中溶液在低压过滤步骤（q）中过滤之前，具有满足以下等式1和5的pH（X）和盐离子强度（Y（mM））：0＆nlE; Y＆nlE; 150X-590（等式1）和3.5＆nlE; X＆nlE; 8.0（等式5）或下面的等式4和5：Y = 0（等式4）和3.5＆nlE; X＆nlE; 8.0（等式5）。

4. 发明申请

US20120077963A1 METHOD FOR REMOVING VIRUSES FROM HIGH CONCENTRATION MONOCLONAL ANTIBODY SOLUTION 有权
标题翻译：从高浓度单克隆抗体溶液中去除病毒的方法
公开(公告)号：US20120077963A1
公开(公告)日：2012-03-29
申请号：US13260419
申请日：2010-03-26
申请人： Tomoko Hongo , Masayasu Komuro
发明人： Tomoko Hongo , Masayasu Komuro
IPC分类号： C07K1/34 , C07K16/00
CPC分类号： C07K1/34 , C07K16/065
摘要： An object of the present invention is to provide a method for removing even small viruses from a high concentration monoclonal antibody solution using a membrane, and thus for recovering the antibody within a short time at high yield in the form of a filtrate. The present invention provides a method for producing a preparation containing a monoclonal antibody, which comprises a step of removing viruses by filtering viruses in a monoclonal antibody solution using a virus-removing membrane, wherein (1) the monomer content of the monoclonal antibody accounts for 90% or more; (2) the monoclonal antibody concentration in the monoclonal antibody solution ranges from 20 mg/ml to 100 mg/ml; (3) the monoclonal antibody solution contains at least a basic amino acid; and (4) the parvovirus removal rate of the virus-removing membrane satisfies the following conditions: LRV (Log Reduction Value: logarithmic reduction value) ≧4.
摘要翻译：本发明的目的是提供一种使用膜从高浓度单克隆抗体溶液中除去小病毒的方法，从而以低产率的滤液形式在短时间内回收抗体。本发明提供了含有单克隆抗体的制剂的制备方法，其包括使用病毒除去膜通过用单克隆抗体溶液过滤病毒来除去病毒的步骤，其中（1）单克隆抗体的单体含量占 90％以上; （2）单克隆抗体溶液中的单克隆抗体浓度为20mg / ml至100mg / ml; （3）单克隆抗体溶液至少含有碱性氨基酸; （4）病毒除去膜的细小病毒除去率满足以下条件：LRV（Log Reduction Value：对数降低值）≥4。

5. 发明授权

US06284914B1 Highly water-soluble metalloproteinase inhibitors 失效
标题翻译：高度水溶性金属蛋白酶抑制剂
公开(公告)号：US06284914B1
公开(公告)日：2001-09-04
申请号：US09492149
申请日：2000-01-27
申请人： Junko Fujisawa , Eiko Suda , Katsuhiro Igeta , Tadanori Morikawa , Tetsunori Fujisawa , Shinjiro Odake , Yasuo Morita , Tomoko Hongo , Hajime Ito
发明人： Junko Fujisawa , Eiko Suda , Katsuhiro Igeta , Tadanori Morikawa , Tetsunori Fujisawa , Shinjiro Odake , Yasuo Morita , Tomoko Hongo , Hajime Ito
IPC分类号： C07C23704
CPC分类号： C07C323/60 , A61K31/165 , C07C239/06 , C07C259/06 , C07C279/14 , C07C279/16 , C07C305/24 , C07C309/61 , C07F9/12
摘要： New compounds of general formulae (III), (IV) and (V).
摘要翻译：通式（III），（IV）和（V）的新化合物。

6. 发明授权

US09056896B2 Method for removing viruses from high concentration monoclonal antibody solution 有权
标题翻译：从高浓度单克隆抗体溶液中除去病毒的方法
公开(公告)号：US09056896B2
公开(公告)日：2015-06-16
申请号：US13260419
申请日：2010-03-26
申请人： Tomoko Hongo , Masayasu Komuro
发明人： Tomoko Hongo , Masayasu Komuro
IPC分类号： A23J1/00 , C07K1/34 , C07K16/06
CPC分类号： C07K1/34 , C07K16/065
摘要： An object of the present invention is to provide a method for removing even small viruses from a high concentration monoclonal antibody solution using a membrane, and thus for recovering the antibody within a short time at high yield in the form of a filtrate. The present invention provides a method for producing a preparation containing a monoclonal antibody, which comprises a step of removing viruses by filtering viruses in a monoclonal antibody solution using a virus-removing membrane, wherein (1) the monomer content of the monoclonal antibody accounts for 90% or more; (2) the monoclonal antibody concentration in the monoclonal antibody solution ranges from 20 mg/ml to 100 mg/ml; (3) the monoclonal antibody solution contains at least a basic amino acid; and (4) the parvovirus removal rate of the virus-removing membrane satisfies the following conditions: LRV (Log Reduction Value: logarithmic reduction value)≧4.
摘要翻译：本发明的目的是提供一种使用膜从高浓度单克隆抗体溶液中除去小病毒的方法，从而以低产率的滤液形式在短时间内回收抗体。本发明提供了含有单克隆抗体的制剂的制备方法，其包括使用病毒除去膜通过用单克隆抗体溶液过滤病毒来除去病毒的步骤，其中（1）单克隆抗体的单体含量占 90％以上; （2）单克隆抗体溶液中的单克隆抗体浓度为20mg / ml至100mg / ml; （3）单克隆抗体溶液至少含有碱性氨基酸; （4）病毒除去膜的细小病毒除去率满足以下条件：LRV（Log Reduction Value：对数降低值）≥4。

7. 发明授权

US07745499B2 Metal colloid solution 有权
标题翻译：金属胶体溶液
公开(公告)号：US07745499B2
公开(公告)日：2010-06-29
申请号：US10564837
申请日：2004-07-16
申请人： Tomoko Hongo , Naoko Hamasaki , Shoichi Ide , Fumihiko Yamaguchi , Mitsunori Kubozaki
发明人： Tomoko Hongo , Naoko Hamasaki , Shoichi Ide , Fumihiko Yamaguchi , Mitsunori Kubozaki
IPC分类号： C09K3/00
CPC分类号： B01D65/102 , A61K33/24 , A61K45/06 , B01J13/0043 , Y02A50/465
摘要： A colloid solution that exhibits storage stability and pH stability, being useful as viral substitute particles for use in an integrity test for virus removal membrane. In particular, a metal colloid solution characterized in that it comprises metal particles or metal compound particles of 1 to 100 nm average diameter, a water soluble high-molecular-weight dispersant having an N group and water and/or a water soluble organic solvent, the metal colloid solution being stable for a prolonged period of time and being stable in at least pH values ranging from 4 to 11.
摘要翻译：具有保存稳定性和pH稳定性的胶体溶液，可用作用于病毒去除膜完整性测试的病毒代用颗粒。特别是金属胶体溶液，其特征在于它包括平均直径为1至100nm的金属颗粒或金属化合物颗粒，具有N基团的水溶性高分子量分散剂和/或水溶性有机溶剂，金属胶体溶液长时间稳定，至少在4至11的pH范围内是稳定的。

8. 发明申请

US20060235085A1 Metal colloid solution 有权
标题翻译：金属胶体溶液
公开(公告)号：US20060235085A1
公开(公告)日：2006-10-19
申请号：US10564837
申请日：2004-07-16
申请人： Tomoko Hongo , Naoko Hamasaki , Shoichi Ide , Fumihiko Yamaguchi , Mitsunori Kubozaki
发明人： Tomoko Hongo , Naoko Hamasaki , Shoichi Ide , Fumihiko Yamaguchi , Mitsunori Kubozaki
IPC分类号： B01F3/12 , B01F17/00
CPC分类号： B01D65/102 , A61K33/24 , A61K45/06 , B01J13/0043 , Y02A50/465
摘要： A colloid solution that exhibits storage stability and pH stability, being useful as viral substitute particles for use in an integrity test for virus removal membrane. In particular, a metal colloid solution characterized in that it comprises metal particles or metal compound particles of 1 to 100 nm average diameter, a water soluble high-molecular-weight dispersant having an N group and water and/or a water soluble organic solvent, the metal colloid solution being stable for a prolonged period of time and being stable in at least pH values ranging from 4 to 11.
摘要翻译：具有保存稳定性和pH稳定性的胶体溶液，可用作用于病毒去除膜完整性测试的病毒代用颗粒。特别是金属胶体溶液，其特征在于它包括平均直径为1至100nm的金属颗粒或金属化合物颗粒，具有N基团的水溶性高分子量分散剂和/或水溶性有机溶剂，金属胶体溶液长时间稳定，至少在4至11的pH范围内是稳定的。

9. 发明授权

US06228841B1 Peptide derivatives 失效
标题翻译：肽衍生物
公开(公告)号：US06228841B1
公开(公告)日：2001-05-08
申请号：US09029604
申请日：1998-04-28
申请人： Shinobu Sakurada , Toru Okayama , Eriko Nukui , Kazuya Hongo , Tadashi Ogawa , Tomoko Hongo , Satoko Takeshima , Nobuhiro Take , Masaharu Nakano
发明人： Shinobu Sakurada , Toru Okayama , Eriko Nukui , Kazuya Hongo , Tadashi Ogawa , Tomoko Hongo , Satoko Takeshima , Nobuhiro Take , Masaharu Nakano
IPC分类号： A61K3807
CPC分类号： C07K7/02 , A61K38/00 , C07K5/0202
摘要： Compounds represented by the following general formula and salts thereof; Y-L-Tyr-Q-NR1—CH(R2)—CO—X, wherein R1 represents hydrogen or C1-6 alkyl; R2 represents optionally substituted benzyl; Q represents D- or L-Arg; Y represents two hydrogen atoms of N-terminal amino group of L-Tyr, or one or two functional groups substituting for the hydrogen atoms, for example, a C1-6 alkyl optionally having amino or carboxy; and X represents N-methyl-&bgr;-alanine and other. The compounds have analgesic effect and can be used for the treatment of cancer pain or the like.
摘要翻译：由以下通式表示的化合物及其盐; Y-L-Tyr-Q-NR1-CH（R2）-CO-X，其中R1表示氢或C1-6烷基; R2代表任选取代的苄基; Q表示D-或L-Arg; Y代表L-Tyr的N末端氨基的两个氢原子，或一个或两个取代氢原子的官能团，例如任选具有氨基或羧基的C 1-6烷基; X表示N-甲基-β-丙氨酸等。这些化合物具有镇痛作用，可用于治疗癌症疼痛等。

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