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公开(公告)号：WO2023075812A1
公开(公告)日：2023-05-04
申请号：PCT/US2021/065024
申请日：2021-12-22
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , RADTKE, Klaus Peter , DORFMAN, Ryan , WHELIHAN, Matthew
Abstract: Systems and methods are described in which proteins are isolated from complex solution using successive chromatographic separations that retain the protein of interest in the flow-through. At least one of the chromatography media used is selected to be capable of interacting with both contaminants and the protein of interest, however capacity of this media is selected such that the protein on interest is displaced and remains in the flow-through.
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公开(公告)号：WO2021054997A1
公开(公告)日：2021-03-25
申请号：PCT/US2020/012860
申请日：2020-01-09
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , RADTKE, Peter , BRILLHART, Kurt L.
IPC: C07K1/22 , C07K14/745 , C07K14/76
Abstract: A method for producing a modified cryo-poor precipitate that can be utilized in chromatography without intervening precipitation steps is provided. While thawing frozen plasma at low temperature a precipitating compound (e.g. a salt of an organic acid) is added in small amounts. The resulting modified cryo-poor plasma has a reduced tendency to foul chromatography media, permitting direct application to such media without the need for additional precipitation steps. The resulting modified cryoprecipitate has a higher content of cold-insoluble proteins (such as clotting factors), and can be resolubilized and processed further.
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公开(公告)号：WO2007030244A2
公开(公告)日：2007-03-15
申请号：PCT/US2006/030465
申请日：2006-08-04
Applicant: PLASMA TECHNOLOGIES, LLC , ZURLO, Gene , CURTIN, Dennis , LOUDERBACK, Allan
Inventor： ZURLO, Gene , CURTIN, Dennis , LOUDERBACK, Allan
IPC: C07K16/18 , C07K14/765
CPC classification number: A61M1/3693 , A61K2035/124 , A61M1/3486 , A61M1/3696 , A61M2202/0419
Abstract: An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diaflltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.
Abstract translation: 有效的大规模无酒精血浆分离生产方法，产生高产，非变性，双病毒灭活的静脉注射人免疫球蛋白（IgG）产品。 该方法在两个初始分馏步骤中使用一种或多种盐，所述盐包括柠檬酸钠，乙酸钠，葡糖酸钠，硫酸铵，氯化钠，硫酸钠和氯化铵，然后进行脱氮以除去所用的盐。 还公开了通过所公开的本发明方法的方法使用醇的方法。
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公开(公告)号：WO2022071990A1
公开(公告)日：2022-04-07
申请号：PCT/US2021/026462
申请日：2021-04-08
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , RADTKE, Klaus Peter , CURTIN, Dennis , BRILLHART, Kurt L.
Abstract: Compositions and methods are provided that simplify isolation of proteins of interest from serum or plasma. Finely divided silica or a similar lipid/lipoprotein binding solid is used in combination with a protein precipitating agent to generate a solution that includes the protein of interest and that can be applied to chromatography media without resulting in significant fouling of the media. The method is particularly suitable for isolation of immunoglobulin G.
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公开(公告)号：WO2021054998A1
公开(公告)日：2021-03-25
申请号：PCT/US2020/012961
申请日：2020-01-10
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , RADTKE, Peter , BRILLHART, Kurt L.
Abstract: Methods for isolating proteins from solution by precipitation are provided. A nonvolatile precipitation agent is added to an aqueous protein solution at a low concentration. Water is then removed from the resulting solution until the precipitant and the protein content of the solution increase to a concentration that provides the desired segregation of proteins between supernatant and precipitate. Additional water can be removed from the supernatant to provide additional fractionation. Water can be removed by evaporation (e.g. under reduced pressure) and/or diafiltration.
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Patent Agency Ranking
公开(公告)号：WO2017066683A1
公开(公告)日：2017-04-20
申请号：PCT/US2016/057196
申请日：2016-10-14
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , HELDEBRANT, PH.D., Charles , NOWOTNIK, David Peter
Abstract: A method of producing protein products including alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins from plasma includes steps of: (1) adding a salt to the blood product to produce a first intermediate, wherein the salt comprises between 11-13 wt% of the first intermediate; (2) separating the first intermediate to produce a first supernatant and a first paste; (3) adding a salt to the first intermediate to produce a second intermediate, wherein the salt comprises between 21-23 wt% of the second intermediate; (4) separating the second intermediate to produce a second supernatant and a second paste; (5) separating a third intermediate from the second supernatant by affinity chromatography; and (6) separating the third intermediate by ion exchange chromatography to produce an eluate containing the protein product. Advantageously, the inventive methods are simple and produce alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins in high yields.
Abstract translation: 从血浆产生包括α-1-蛋白酶抑制剂，γ-球蛋白，白蛋白和其他蛋白质的蛋白质产品的方法包括以下步骤：（1）向血液产品中加入盐以产生第一种 中间体，其中盐包含11-13重量％的第一中间体; （2）分离第一中间体以产生第一上清液和第一糊剂; （3）向第一中间体中加入盐以制备第二中间体，其中盐包含21-23重量％的第二中间体; （4）分离第二中间体以产生第二上清液和第二糊剂; （5）通过亲和层析从第二上清液分离第三中间体; 和（6）通过离子交换色谱分离第三中间体以产生含有蛋白质产物的洗脱液。 有利的是，本发明的方法简单并且以高产率生产α-1-蛋白酶抑制剂，γ-球蛋白，白蛋白和其他蛋白质。
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公开(公告)号：WO2007030244A3
公开(公告)日：2009-05-22
申请号：PCT/US2006030465
申请日：2006-08-04
Applicant: PLASMA TECHNOLOGIES LLC , ZURLO GENE , CURTIN DENNIS , LOUDERBACK ALLAN
Inventor： ZURLO GENE , CURTIN DENNIS , LOUDERBACK ALLAN
IPC: C07K16/18 , C07K14/765
CPC classification number: A61M1/3693 , A61K2035/124 , A61M1/3486 , A61M1/3696 , A61M2202/0419
Abstract: An efficacious large-scale alcohol-free plasma fractionation production process which produces a high-yielding, non-denatured, double viral-inactivated intravenous human immune gamma globulin (IgG) product. The process employs one or more salts from a group of salts comprising sodium citrate, sodium acetate, sodium gluconate, ammonium sulfate, sodium chloride, sodium sulfate and ammonium chloride in two initial fractionation steps, followed by diaflltration to remove those salts employed. A process which employs alcohol via the process of the disclosed inventive method is also disclosed.
Abstract translation: 有效的大规模无酒精血浆分离生产方法，产生高产，非变性，双病毒灭活的静脉注射人免疫球蛋白（IgG）产品。 该方法在两个初始分馏步骤中使用一种或多种盐，所述盐包括柠檬酸钠，乙酸钠，葡糖酸钠，硫酸铵，氯化钠，硫酸钠和氯化铵，然后进行脱氮以除去所用的盐。 还公开了通过所公开的本发明方法的方法使用醇的方法。
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公开(公告)号：WO2022146856A1
公开(公告)日：2022-07-07
申请号：PCT/US2021/065017
申请日：2021-12-22
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , RADTKE, Klaus Peter , DORFMAN, Ryan , WHELIHAN, Matthew
Abstract: Methods are provided for isolation of immunoglobulin G (IgG) from plasma, where IgG is initially fractioned by salt precipitation, followed by successive ion exchange steps in which IgG appears in unbound, flow-through fractions of the ion exchange steps. Some embodiments employ successive anion exchange steps. Other embodiments employ an anion exchange step followed by application of flow-through of the anion exchange step to a cation exchange step, with IgG collected in flow-through fractions from the cation exchange step. IgG is collected at high yield (typically about 75% or greater) and high purity. Avoidance of binding and elution from chromatography media simplifies processing and scale up without sacrificing IgG quality or yield.
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公开(公告)号：WO2021054999A1
公开(公告)日：2021-03-25
申请号：PCT/US2020/013139
申请日：2020-01-10
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , CURTIN, Dennis , RADTKE, Peter , BRILLHART, Kurt L.
Abstract: Compositions of the inventive concept provide a therapeutic protein with less than 2% contamination by the therapeutic protein in denatured form. Such compositions provide enhanced specific activity and improved stability on storage and/or in serum than corresponding therapeutic protein preparations resulting from conventional isolation methods.
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公开(公告)号：WO2017136785A1
公开(公告)日：2017-08-10
申请号：PCT/US2017/016595
申请日：2017-02-03
Applicant: PLASMA TECHNOLOGIES, LLC
Inventor： ZURLO, Eugene , NOWOTNIK, David Peter , HELDEBRANT, Charles , CURTIN, Dennis
CPC classification number: C07K1/16 , A61K38/16 , C07K1/22 , C07K1/30 , C07K1/34 , C07K14/81 , C07K16/06
Abstract: Methods of producing multiple protein products from blood-based materials including alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins are described herein. The inventive methods include steps of: salt fractionation, chromatography, ultrafiltration, diafiltration, solvent-detergent treatment, and sterile filtration. Advantageously, the inventive methods are simple and produce alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins in high yields. The sequence of process steps can be selected to obtain multiple products from various in-process materials, such as supernatants, pastes, chromatography flow-though, and chromatography washes.
Abstract translation: 本文描述了由血基材料（包括α-1-蛋白酶抑制剂，γ球蛋白，白蛋白和其他蛋白质）生产多种蛋白质产物的方法。 本发明的方法包括以下步骤：盐分级分离，色谱法，超滤，渗滤，溶剂 - 去污剂处理和无菌过滤。 有利的是，本发明的方法简单并且以高产率产生α-1-蛋白酶抑制剂，γ-球蛋白，白蛋白和其他蛋白质。 可以选择工艺步骤的顺序以获得来自各种过程中材料的多种产物，例如上清液，糊剂，层析流过液和层析液洗涤液。
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