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1. 发明申请

US20160152690A1 PROCESS FOR INCREASED YIELD OF IMMUNOGLOBULIN FROM HUMAN PLASMA 审中-公开
标题翻译：从人类血浆中增加免疫球蛋白的过程
公开(公告)号：US20160152690A1
公开(公告)日：2016-06-02
申请号：US14576261
申请日：2014-12-19
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： ASHOK KUMAR NUVULA , ZINIA CHAKRABORTY , VVS SAILESH BAVIRISETTI , THIRUPATI REDDY KATKURI , UMA DEVI KOMATH
IPC分类号： C07K16/06 , C07K1/18
CPC分类号： C07K16/065 , A61K38/00 , A61K2039/505 , C07K1/18 , C07K2317/10 , C07K2317/21
摘要： The present invention discloses a preparation method for large scale production of human immunoglobulins (IgG) with high yields by an improved all-chromatography process scheme that eliminates ethanol precipitation. The process of extracting immunoglobulins is such that the other therapeutic proteins in plasma are left unaffected and are available for extraction separately from the same plasma sample. The yields obtained are in the range of 7 to 8 grams of IgG per liter of plasma. The high yielding process scheme of the present invention comprises of chromatographic steps and viral inactivation or removal steps to obtain a purified immunoglobulin protein that complies with pharmacopoeial limits and is suitable for therapeutic administration (normal intravenous immunoglobulin—IVIG).
摘要翻译：本发明公开了一种通过改进的全层析方法大规模生产人类免疫球蛋白（IgG）的制备方法，该方法可以消除乙醇沉淀。提取免疫球蛋白的过程使得血浆中的其它治疗性蛋白质不受影响，并且可用于从相同的血浆样品中分离提取。获得的产量在每升等离子体中为7至8克IgG的范围内。本发明的高产过程方案包括色谱步骤和病毒灭活或去除步骤，以获得符合药典极限的纯化免疫球蛋白，并且适用于治疗性给药（正常静脉注射免疫球蛋白-IVIG）。

2. 发明申请

US20160137719A1 PROCESS FOR PRODUCING HIGH PURITY FIBRINOGEN AND THROMBIN FOR FIBRIN SEALANT 审中-公开
标题翻译：生产用于纤维素密封剂的高纯度纤维蛋白和硫蛋白的方法
公开(公告)号：US20160137719A1
公开(公告)日：2016-05-19
申请号：US14883574
申请日：2015-10-14
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： ASHOK KUMAR NUVULA , MITALI SAMADDAR , NEELIMA VADDE , ZINIA CHAKRABORTY , SWAPNA SAGAR DUGGINENI , UMA DEVI KOMATH
IPC分类号： C07K14/75 , A61L24/02 , C12N9/74 , A61L24/10
CPC分类号： C07K14/75 , A61L24/02 , A61L24/106 , A61L24/108 , C12N9/6429 , C12Y304/21005
摘要： The present invention relates to a fibrin sealant kit comprising purified fibrinogen and thrombin. The invention particularly relates to an improved chromatographic process for the purification of thrombin and fibrinogen components devoid of any significant plasminogen and other impurities. The absence of plasminogen facilitates the exclusion of a proteolytic inhibitor (aprotinin) from among the kit components.
摘要翻译：本发明涉及包含纯化的纤维蛋白原和凝血酶的纤维蛋白密封剂试剂盒。本发明特别涉及用于纯化没有任何明显的纤溶酶原和其他杂质的凝血酶和纤维蛋白原成分的改进的色谱方法。不存在纤溶酶原有助于从试剂盒组分中排除蛋白水解抑制剂（抑肽酶）。

3. 发明申请

US20150210737A1 INTEGRATED PROCESS FOR THE PRODUCTION OF THERAPEUTICS (HUMAN ALBUMIN, INTRAVENOUS IMMUNOGLOBULINS, CLOTTING FACTOR VIII AND CLOTTING FACTOR IX) FROM HUMAN PLASMA 审中-公开
标题翻译：从人类血浆中生产治疗药物的综合方法（人类血红蛋白，人造血管生成素，衣服因子VIII和衣物因子IX）
公开(公告)号：US20150210737A1
公开(公告)日：2015-07-30
申请号：US14530840
申请日：2014-11-03
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： NEELIMA VADDE , MITALI SAMADDAR , ASHOK NUVULA , ZINIA CHAKRABORTY , SWAPNA SAGAR DUGGINENI , UMA DEVI KOMATH
IPC分类号： C07K1/36 , C12N9/64 , C07K1/18
CPC分类号： C07K1/36 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3804 , B01D15/3828 , C07K1/18 , C12N9/644 , Y02P20/125
摘要： The invention relates to an integrated scheme for fractionation and purification of plasma products (human albumin, intravenous immunoglobulin (IVIG), clotting factor VIII and clotting factor IX) by sequential chromatography and virus reduction steps. The therapeutically administrable protein IVIG has purity levels exceeding 98%, aggregates and dimers at less than 0.2%, Fc function of >90% and anti-complementary activity of less than 0.5 CH50 per mg of Ig. The distribution of IgG isomers is comparable to the ranges seen in normal plasma. Human albumin for therapeutic use, purified by this integrated scheme has an electrophoretic purity of close to 100%, with monomers exceeding 98%. The levels of aluminium and pre-kallikrein activator are below the detection limit for the respective tests. The Factor IX preparations have a specific activity of ≧200 IU/mg. The impurity levels of Factor-II, Factor VII, Factor X are at least 10-fold lesser (≦0.5% instead of 5%) and the heparin impurity of ≦0.01 IU (against 0.5 IU limit for this impurity) is 50-fold lesser the specified pharmacopoeial limits.The purification carried out by an all-chromatography scheme, avoids the use of ethanol precipitation in the entire manufacturing process of the said four plasma products. The invention describes an integrated process for purifying four different proteins from human plasma to high therapeutic grade purity levels, with a potential to purify more therapeutic proteins from a given plasma sample by incorporating additional chromatography steps in the sequence.
摘要翻译：本发明涉及通过顺序层析和病毒还原步骤分离和纯化血浆产物（人白蛋白，静脉内免疫球蛋白（IVIG），凝血因子VIII和凝血因子IX）的综合方案。治疗可施用的蛋白IVIG的纯度水平超过98％，聚集体和二聚体小于0.2％，Fc功能> 90％，抗互补活性小于0.5CH50 / mg Ig。 IgG异构体的分布与正常血浆中所见的范围相当。通过该整合方案纯化的用于治疗用途的人白蛋白具有接近100％的电泳纯度，单体超过98％。铝和前激肽释放酶激活剂的水平低于相应检测的检测限。因子IX制剂具有≥200IU/ mg的比活性。因子II，因子VII，因子X的杂质水平至少为10倍（＆nlE; 0.5％而不是5％），肝素杂质为0.01IU（相对于该杂质的0.5IU限度）为50 - 指定的药典极限更小。通过全层析方案进行的纯化避免了在所述四种等离子体产物的整个制造过程中使用乙醇沉淀。本发明描述了一种用于从人血浆中纯化四种不同蛋白质至高治疗级纯度水平的综合方法，具有通过在序列中引入另外的色谱步骤来纯化来自给定血浆样品的更多治疗性蛋白质的潜力。

4. 发明授权

US09932388B2 Chromatographic process for producing high purity fibrinogen and thrombin 有权
公开(公告)号：US09932388B2
公开(公告)日：2018-04-03
申请号：US14883574
申请日：2015-10-14
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： Ashok Kumar Nuvula , Mitali Samaddar , Neelima Vadde , Zinia Chakraborty , Swapna Sagar Duggineni , Uma Devi Komath
IPC分类号： C07K14/75 , A61L24/10 , A61L24/02 , C12N9/74
CPC分类号： C07K14/75 , A61L24/02 , A61L24/106 , A61L24/108 , C12N9/6429 , C12Y304/21005
摘要： The present invention relates to a chromatographic process for obtaining purified fibrinogen and thrombin from human plasma. The purified fibrinogen and thrombin preparations contain plasminogen in amounts less than 1 ug/mL. The low levels of plasminogen eliminates use of a proteolytic inhibitor, such as aprotinin in fibrin sealant kits which are used for human therapeutic applications.

5. 发明授权

US09663553B2 Integrated process for the production of therapeutics (human albumin, immunoglobulins, clotting factor VIII and clotting factor IX) from human plasma 有权
公开(公告)号：US09663553B2
公开(公告)日：2017-05-30
申请号：US14530840
申请日：2014-11-03
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： Neelima Vadde , Mitali Samaddar , Ashok Nuvula , Zinia Chakraborty , Swapna Sagar Duggineni , Uma Devi Komath
IPC分类号： A61K38/00 , C07K1/36 , C07K1/18 , C12N9/64 , B01D15/34 , B01D15/36 , B01D15/38
CPC分类号： C07K1/36 , B01D15/34 , B01D15/362 , B01D15/363 , B01D15/3804 , B01D15/3828 , C07K1/18 , C12N9/644 , Y02P20/125
摘要： The invention is an integrated process for the isolation and purification of plasma derived clotting Factor VIII, clotting Factor IX, albumin and immunoglobulin without the use of ethanol precipitation. The integrated process comprises of sequential chromatography steps of gel filtration, anion exchange and cation exchange chromatographies, followed by viral inactivation and removal steps. The present invention has the advantage of being a mild process that does not denature or aggregate the proteins and provides high yields of several therapeutic grade plasma proteins from a given volume of plasma.

6. 发明授权

US09556253B2 Process for increased yield of immunoglobulin from human plasma 有权
标题翻译：从人血浆中提高免疫球蛋白产量的方法
公开(公告)号：US09556253B2
公开(公告)日：2017-01-31
申请号：US14576261
申请日：2014-12-19
申请人： HEMARUS THERAPEUTICS LIMITED
发明人： Ashok Kumar Nuvula , Zinia Chakraborty , Vvs Sailesh Bavirisetti , Thirupati Reddy Katkuri , Uma Devi Komath
IPC分类号： C07K1/18 , A61K38/00 , C07K16/06 , A61K39/00
CPC分类号： C07K16/065 , A61K38/00 , A61K2039/505 , C07K1/18 , C07K2317/10 , C07K2317/21
摘要： The present invention discloses a preparation method for large scale production of human immunoglobulins (IgG) with high yields by an improved all-chromatography process scheme that eliminates ethanol precipitation. The process of extracting immunoglobulins is such that the other therapeutic proteins in plasma are left unaffected and are available for extraction separately from the same plasma sample. The yields obtained are in the range of 7 to 8 grams of IgG per liter of plasma. The high yielding process scheme of the present invention comprises of chromatographic steps and viral inactivation or removal steps to obtain a purified immunoglobulin protein that complies with pharmacopoeial limits and is suitable for therapeutic administration (normal intravenous immunoglobulin—IVIG).
摘要翻译：本发明公开了一种通过改进的全层析方法大规模生产人类免疫球蛋白（IgG）的制备方法，该方法可以消除乙醇沉淀。提取免疫球蛋白的过程使得血浆中的其它治疗性蛋白质不受影响，并且可用于从相同的血浆样品中分离提取。获得的产量在每升等离子体中为7至8克IgG的范围内。本发明的高产过程方案包括色谱步骤和病毒灭活或去除步骤，以获得符合药典极限的纯化免疫球蛋白，并且适用于治疗性给药（正常静脉注射免疫球蛋白-IVIG）。

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