CA2621025C - An ultra-high yield intravenous immune globulin preparation - Google Patents
An ultra-high yield intravenous immune globulin preparation Download PDFInfo
- Publication number
- CA2621025C CA2621025C CA2621025A CA2621025A CA2621025C CA 2621025 C CA2621025 C CA 2621025C CA 2621025 A CA2621025 A CA 2621025A CA 2621025 A CA2621025 A CA 2621025A CA 2621025 C CA2621025 C CA 2621025C
- Authority
- CA
- Canada
- Prior art keywords
- salt
- euglobulin
- depleted intermediate
- depleted
- producing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000001990 intravenous administration Methods 0.000 title abstract 2
- 108060003951 Immunoglobulin Proteins 0.000 title 1
- 102000018358 immunoglobulin Human genes 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 16
- 150000003839 salts Chemical class 0.000 claims abstract 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000001509 sodium citrate Substances 0.000 claims abstract 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract 2
- 102000005686 Serum Globulins Human genes 0.000 claims 11
- 108010045362 Serum Globulins Proteins 0.000 claims 11
- 239000008280 blood Substances 0.000 claims 5
- 210000004369 blood Anatomy 0.000 claims 5
- 239000000463 material Substances 0.000 claims 5
- 239000002244 precipitate Substances 0.000 claims 4
- 239000010836 blood and blood product Substances 0.000 claims 2
- 229940125691 blood product Drugs 0.000 claims 2
- 238000007865 diluting Methods 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- 102000009027 Albumins Human genes 0.000 claims 1
- 108010088751 Albumins Proteins 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- 238000011026 diafiltration Methods 0.000 claims 1
- 229940050410 gluconate Drugs 0.000 claims 1
- 239000012528 membrane Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 235000002639 sodium chloride Nutrition 0.000 abstract 4
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- 238000005194 fractionation Methods 0.000 abstract 2
- AEQDJSLRWYMAQI-UHFFFAOYSA-N 2,3,9,10-tetramethoxy-6,8,13,13a-tetrahydro-5H-isoquinolino[2,1-b]isoquinoline Chemical compound C1CN2CC(C(=C(OC)C=C3)OC)=C3CC2C2=C1C=C(OC)C(OC)=C2 AEQDJSLRWYMAQI-UHFFFAOYSA-N 0.000 abstract 1
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 abstract 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 abstract 1
- 235000019270 ammonium chloride Nutrition 0.000 abstract 1
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 abstract 1
- 229910052921 ammonium sulfate Inorganic materials 0.000 abstract 1
- 235000011130 ammonium sulphate Nutrition 0.000 abstract 1
- 108010074605 gamma-Globulins Proteins 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000001632 sodium acetate Substances 0.000 abstract 1
- 235000017281 sodium acetate Nutrition 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- 235000011083 sodium citrates Nutrition 0.000 abstract 1
- 239000000176 sodium gluconate Substances 0.000 abstract 1
- 235000012207 sodium gluconate Nutrition 0.000 abstract 1
- 229940005574 sodium gluconate Drugs 0.000 abstract 1
- 229910052938 sodium sulfate Inorganic materials 0.000 abstract 1
- 235000011152 sodium sulphate Nutrition 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/76—Albumins
- C07K14/765—Serum albumin, e.g. HSA
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/217,956 US20070049732A1 (en) | 2005-09-01 | 2005-09-01 | Ultra-high yield intravenous immune globulin preparation |
| US11/217,956 | 2005-09-01 | ||
| US11/232,527 US7879331B2 (en) | 2005-09-01 | 2005-09-22 | Ultra-high yield intravenous immune globulin preparation |
| US11/232,527 | 2005-09-22 | ||
| PCT/US2006/030465 WO2007030244A2 (en) | 2005-09-01 | 2006-08-04 | An ultra-high yield intravenous immune globulin preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2621025A1 CA2621025A1 (en) | 2007-03-15 |
| CA2621025C true CA2621025C (en) | 2014-10-14 |
Family
ID=37805216
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2621025A Active CA2621025C (en) | 2005-09-01 | 2006-08-04 | An ultra-high yield intravenous immune globulin preparation |
Country Status (6)
| Country | Link |
|---|---|
| US (3) | US20070049732A1 (cg-RX-API-DMAC7.html) |
| JP (1) | JP5178518B2 (cg-RX-API-DMAC7.html) |
| CN (1) | CN101528776B (cg-RX-API-DMAC7.html) |
| AT (1) | ATE541858T1 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2621025C (cg-RX-API-DMAC7.html) |
| ES (1) | ES2384930T3 (cg-RX-API-DMAC7.html) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2007015476A (es) | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| AU2009236305B2 (en) * | 2008-04-15 | 2014-04-10 | Grifols Therapeutics Inc. | Two-stage ultrafiltration/diafiltration |
| US20100322943A1 (en) | 2009-06-17 | 2010-12-23 | Thomas Cantor | Therapeutic and diagnostic affinity purified specific polyclonal antibodies |
| IT1397061B1 (it) | 2009-12-28 | 2012-12-28 | Kedrion Spa | Nuovo processo di purificazione su scala industriale di gammaglobuline da plasma umano per uso industriale. |
| US9764022B2 (en) | 2011-07-18 | 2017-09-19 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Methods and compositions for inhibiting polyomavirus-associated pathology |
| WO2013066986A1 (en) * | 2011-10-31 | 2013-05-10 | Puget Sound Blood Genter | Antibody response phenotyping |
| CN102949719A (zh) * | 2012-04-28 | 2013-03-06 | 上海市徐汇区中心医院 | 静脉注射免疫球蛋白抑制霍乱毒素和半乳糖凝集素-1结合到神经节苷脂gm1 |
| US9663553B2 (en) | 2014-01-29 | 2017-05-30 | Hemarus Therapeutics Limited | Integrated process for the production of therapeutics (human albumin, immunoglobulins, clotting factor VIII and clotting factor IX) from human plasma |
| US9556253B2 (en) | 2014-12-02 | 2017-01-31 | Hemarus Therapeutics Limited | Process for increased yield of immunoglobulin from human plasma |
| US10809247B2 (en) * | 2015-10-15 | 2020-10-20 | Plasma Technologies, Llc | Methods for extracting proteins from blood plasma |
| CN108779144B (zh) | 2016-02-03 | 2022-06-14 | 普莱泽玛科技有限公司 | 从血液原料中提取蛋白质的方法 |
| CA3040899A1 (en) | 2016-10-21 | 2018-04-26 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| US10259865B2 (en) | 2017-03-15 | 2019-04-16 | Adma Biologics, Inc. | Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection |
| CN108008060B (zh) * | 2017-09-21 | 2020-07-28 | 中国农业科学院农业质量标准与检测技术研究所 | 一种饲料中羟脯氨酸的测定方法及试剂 |
| CN114746108A (zh) * | 2019-09-20 | 2022-07-12 | 等离子体技术有限责任公司 | 治疗性蛋白质组合物和方法 |
| US10815270B1 (en) * | 2019-09-20 | 2020-10-27 | Plasma Technologies, Llc | Compositions and methods for high efficiency protein precipitation |
| JP2024501025A (ja) * | 2020-12-28 | 2024-01-10 | プラズマ テクノロジーズ エルエルシー | 免疫グロブリンｇのプロセススケールでの単離のためのシステム及び方法 |
| CN115369104B (zh) * | 2022-09-27 | 2023-09-08 | 四川新川义生物科技有限责任公司 | 一种精制胃蛋白酶的方法 |
| WO2025085544A1 (en) * | 2023-10-17 | 2025-04-24 | Plasma Technologies, Llc | Integrated process for isolation of plasma proteins |
Family Cites Families (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2390074A (en) * | 1942-02-09 | 1945-12-04 | Research Corp | Protein product and process |
| US4067863A (en) | 1969-03-28 | 1978-01-10 | Watt John G | Blood plasma fractionation |
| CA1064396A (en) | 1975-02-18 | 1979-10-16 | Myer L. Coval | Fractional precipitation of gamma globulin with polyethylene glycol |
| FR2322611A2 (fr) | 1975-09-06 | 1977-04-01 | Biotest Serum Institut Gmbh | Procede de preparation de gamma-globuline |
| US4126605A (en) | 1975-12-29 | 1978-11-21 | Plasmesco Ag | Process of improving the compatibility of gamma globulins |
| US4165370A (en) * | 1976-05-21 | 1979-08-21 | Coval M L | Injectable gamma globulin |
| US4296027A (en) | 1977-08-31 | 1981-10-20 | The Regents Of The University Of Minnesota | Pure intravenous human and animal gamma globulins |
| US4136094A (en) | 1977-08-31 | 1979-01-23 | The Regents Of The University Of Minnesota | Preparation of intravenous human and animal gamma globulins and isolation of albumin |
| EP0002084A1 (en) * | 1977-11-17 | 1979-05-30 | THE PROCTER & GAMBLE COMPANY | Granular detergent compositions for improved greasy soil removal |
| US4163370A (en) | 1977-11-21 | 1979-08-07 | Corning Glass Works | Controlling the drawing rollers to produce diameter perturbations in an optical waveguide |
| DE2835843A1 (de) | 1978-08-16 | 1980-02-28 | Blutspendedienst Dt Rote Kreuz | Verfahren zur herstellung einer fuer die intravenoese anwendung geeigneten gammaglobulinloesung |
| DE2837168A1 (de) | 1978-08-25 | 1980-03-06 | Blutspendedienst Dt Rote Kreuz | Verfahren zur herstellung einer fuer die intravenoese anwendung geeigneten immunglobulinloesung |
| DE2901822A1 (de) | 1979-01-18 | 1980-07-31 | Biotest Serum Institut Gmbh | Verfahren zur herstellung einer fuer die intravenoese applikation geeigneten immunglobulinloesung, die igm in ankonzentrierter form enthaelt |
| US4246085A (en) | 1979-02-16 | 1981-01-20 | United Kingdom Atomic Energy Authority | Fractionation of proteins |
| JPS5681521A (en) | 1979-12-10 | 1981-07-03 | Toyo Soda Mfg Co Ltd | Separation of blood serum and protein |
| US4321192A (en) | 1980-01-10 | 1982-03-23 | Ionics Incorporated | Fractionation of protein mixtures by salt addition followed by dialysis treatment |
| JPS5855432A (ja) | 1981-09-29 | 1983-04-01 | Fujirebio Inc | 静脈注射用免疫グロブリンの製法 |
| US4371520A (en) | 1981-10-28 | 1983-02-01 | The Green Cross Corporation | Process for preparing immunoglobulin suitable for intravenous injection |
| US4624780A (en) | 1982-06-28 | 1986-11-25 | Alpha Therapeutic Corporation | Fractionation of blood plasma |
| US4639513A (en) | 1984-02-02 | 1987-01-27 | Cuno Inc. | Intravenously injectable immunoglobulin G (IGG) and method for producing same |
| US4486282A (en) * | 1983-02-22 | 1984-12-04 | University Patents, Inc. | Precipitation of proteins from salt-containing proteinaceous fluids employing a desalting treatment, and use thereof in selective plasmapheresis |
| JPS59157017A (ja) | 1983-02-25 | 1984-09-06 | Green Cross Corp:The | 静脈投与用γ−グロブリン製剤 |
| FR2543448A1 (fr) | 1983-04-01 | 1984-10-05 | Rhone Poulenc Spec Chim | Procede de fractionnement du plasma |
| US4835257A (en) | 1984-07-07 | 1989-05-30 | Armour Pharma Gmbh | Process for preparing gamma globulin suitable for intravenous administration using peg and a citrate buffer |
| DE3640513A1 (de) | 1986-11-27 | 1988-06-09 | Biotest Pharma Gmbh | Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates |
| US5177194A (en) * | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
| US5310877A (en) | 1993-04-08 | 1994-05-10 | E. I. Du Pont De Nemours And Company | Method for separating serum albumin and gamma globulin |
| US5429746A (en) * | 1994-02-22 | 1995-07-04 | Smith Kline Beecham Corporation | Antibody purification |
| US5561115A (en) | 1994-08-10 | 1996-10-01 | Bayer Corporation | Low temperature albumin fractionation using sodium caprylate as a partitioning agent |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| GB9705810D0 (en) | 1997-03-20 | 1997-05-07 | Common Services Agency | Intravenous immune globulin |
| AT407159B (de) * | 1997-06-13 | 2001-01-25 | Immuno Ag | Verfahren zur abreicherung von viralen und molekularen pathogenen aus einem biologischen material |
| US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| DK2270044T3 (en) | 1998-06-09 | 2015-01-26 | Csl Behring Ag | Liquid immunoglobulin G (IgG) product |
| AUPP971399A0 (en) * | 1999-04-12 | 1999-05-06 | Life Therapeutics Limited | Separation of plasma components |
| SE0001128D0 (sv) | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
| US7297716B2 (en) * | 2000-10-23 | 2007-11-20 | Shanbrom Technologies, Llc | Enhanced production of blood components, blood cells and plasma without freezing |
| US6881731B1 (en) * | 2000-10-23 | 2005-04-19 | Shanbrom Technologies, Llc | Enhancers for microbiological disinfection |
| ES2184594B1 (es) * | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
| MXPA03007069A (es) * | 2001-02-07 | 2004-10-15 | Shanbrom Tech Llc | Acido carboxilico tal como acido citrico para desinfectar o mejorar la produccion de productos sanguineos tales como el plasma, crioprecipitado y/o plaqueta. |
| US6806355B2 (en) | 2001-08-14 | 2004-10-19 | Statens Serum Institut | Purification process for large scale production of Gc-globulin, the Gc-globulin produced hereby, a use of Gc.globulin and a Gc-globulin medicinal product |
| US6893639B2 (en) * | 2001-10-19 | 2005-05-17 | Hemacare Corporation | Method for high yield purification of immune globulins from blood plasma and blood plasma intermediates |
| US6881573B2 (en) | 2003-09-12 | 2005-04-19 | Allan L. Louderback | Augmented solvent/detergent method for inactivating enveloped and non-enveloped viruses |
-
2005
- 2005-09-01 US US11/217,956 patent/US20070049732A1/en not_active Abandoned
- 2005-09-22 US US11/232,527 patent/US7879331B2/en not_active Expired - Lifetime
-
2006
- 2006-08-04 CN CN200680032267.2A patent/CN101528776B/zh active Active
- 2006-08-04 ES ES06800767T patent/ES2384930T3/es active Active
- 2006-08-04 CA CA2621025A patent/CA2621025C/en active Active
- 2006-08-04 AT AT06800767T patent/ATE541858T1/de active
- 2006-08-04 JP JP2008529047A patent/JP5178518B2/ja active Active
-
2008
- 2008-06-06 US US12/134,504 patent/US20080242844A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| JP2009507015A (ja) | 2009-02-19 |
| ES2384930T3 (es) | 2012-07-16 |
| CA2621025A1 (en) | 2007-03-15 |
| CN101528776A (zh) | 2009-09-09 |
| US20080242844A1 (en) | 2008-10-02 |
| CN101528776B (zh) | 2014-01-08 |
| US20070049733A1 (en) | 2007-03-01 |
| ATE541858T1 (de) | 2012-02-15 |
| JP5178518B2 (ja) | 2013-04-10 |
| US7879331B2 (en) | 2011-02-01 |
| US20070049732A1 (en) | 2007-03-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |