CN104245730B - 源自血浆的免疫球蛋白的级分i‑iv‑1沉淀 - Google Patents
源自血浆的免疫球蛋白的级分i‑iv‑1沉淀 Download PDFInfo
- Publication number
- CN104245730B CN104245730B CN201380020621.XA CN201380020621A CN104245730B CN 104245730 B CN104245730 B CN 104245730B CN 201380020621 A CN201380020621 A CN 201380020621A CN 104245730 B CN104245730 B CN 104245730B
- Authority
- CN
- China
- Prior art keywords
- suspension
- igg
- precipitate
- fraction
- ethanol
- 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.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/145—Extraction; Separation; Purification by extraction or solubilisation
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cell Biology (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Analytical Chemistry (AREA)
- Zoology (AREA)
- Virology (AREA)
- Developmental Biology & Embryology (AREA)
- Biotechnology (AREA)
- Communicable Diseases (AREA)
- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Oncology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261602488P | 2012-02-23 | 2012-02-23 | |
| US61/602,488 | 2012-02-23 | ||
| PCT/US2013/027681 WO2013126904A1 (en) | 2012-02-23 | 2013-02-25 | Fraction i-iv-1 precipitation of immunoglobins from plasma |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104245730A CN104245730A (zh) | 2014-12-24 |
| CN104245730B true CN104245730B (zh) | 2017-09-01 |
Family
ID=47833446
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380020621.XA Active CN104245730B (zh) | 2012-02-23 | 2013-02-25 | 源自血浆的免疫球蛋白的级分i‑iv‑1沉淀 |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US9782477B2 (enExample) |
| EP (2) | EP4119574A1 (enExample) |
| JP (1) | JP6291423B2 (enExample) |
| KR (1) | KR101930582B1 (enExample) |
| CN (1) | CN104245730B (enExample) |
| AR (1) | AR090425A1 (enExample) |
| AU (1) | AU2013203112B2 (enExample) |
| BR (1) | BR112014020602B1 (enExample) |
| CA (1) | CA2864715A1 (enExample) |
| CL (1) | CL2014002225A1 (enExample) |
| CO (1) | CO7081143A2 (enExample) |
| DK (1) | DK2817334T3 (enExample) |
| EA (1) | EA032478B1 (enExample) |
| ES (1) | ES2928954T3 (enExample) |
| HU (1) | HUE060195T2 (enExample) |
| IL (1) | IL234103B (enExample) |
| MX (2) | MX365236B (enExample) |
| MY (1) | MY167235A (enExample) |
| NZ (1) | NZ628529A (enExample) |
| PL (1) | PL2817334T3 (enExample) |
| PT (1) | PT2817334T (enExample) |
| SG (1) | SG11201405149UA (enExample) |
| SI (1) | SI2817334T1 (enExample) |
| TW (1) | TWI629283B (enExample) |
| WO (1) | WO2013126904A1 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2013203043B2 (en) | 2013-03-15 | 2016-10-06 | Takeda Pharmaceutical Company Limited | Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs |
| CN104004090A (zh) * | 2014-06-12 | 2014-08-27 | 新疆德源生物工程有限公司 | 一种人免疫球蛋白的制备方法 |
| CN104004091B (zh) * | 2014-06-12 | 2016-08-17 | 新疆德源生物工程有限公司 | 一种人免疫球蛋白的制备工艺 |
| GB201413227D0 (en) | 2014-07-25 | 2014-09-10 | Bioproducts Lab Ltd | Process |
| ES2887588T3 (es) * | 2015-08-13 | 2021-12-23 | Kamada Ltd | Composiciones derivadas de pasta de fracción de Cohn y uso de las mismas |
| US11040068B2 (en) * | 2017-04-26 | 2021-06-22 | Alkahest, Inc. | Dosing regimen for treatment of cognitive and motor impairments with blood plasma and blood plasma products |
| WO2019086463A1 (en) | 2017-10-30 | 2019-05-09 | Baxalta GmbH | Environmentally compatible detergents for inactivation of lipid-enveloped viruses |
| IL278584B2 (en) * | 2018-05-17 | 2025-08-01 | Csl Behring Ag | Method and system of protein extraction |
| CA3157446A1 (en) | 2019-11-20 | 2021-05-27 | Csl Behring Ag | Method for extracting a protein from a precipitate and method for precipitating impurities |
| EP4118108A4 (en) * | 2020-04-10 | 2024-05-15 | Plasma Technologies, LLC | COMPOSITIONS AND METHODS FOR HIGHLY EFFICIENT SIMPLIFIED PROTEIN ISOLATION |
| EP4240757A2 (en) * | 2020-11-09 | 2023-09-13 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
| CN112250757A (zh) * | 2020-11-13 | 2021-01-22 | 广东深蓝生物科技有限公司 | 一种猪血浆中蛋白质的提取纯化方法 |
| 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 |
| CN118580342B (zh) * | 2024-05-20 | 2025-02-07 | 广东丹霞生物制药有限公司 | 一种静脉注射用人免疫球蛋白制剂的制备工艺 |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE348942B (enExample) | 1970-06-02 | 1972-09-18 | Statens Bakteriologiska Labor | |
| US3998946A (en) | 1975-04-23 | 1976-12-21 | The Regents Of The University Of Minnesota | Fibrinogen-free plasminogen-plasmin-free plasma and method of preparing and using same |
| 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 |
| US4499073A (en) | 1981-08-24 | 1985-02-12 | Cutter Laboratories, Inc. | Intravenously injectable immune serum globulin |
| 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 |
| DK166763B1 (da) | 1983-03-16 | 1993-07-12 | Immuno Ag | Immunoglobulin-g-holdig fraktion |
| US5177194A (en) | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
| FR2706466B1 (fr) | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
| US6284874B1 (en) | 1994-06-17 | 2001-09-04 | Alpha Therapeutic Corporation | Process for separating α1-proteinase inhibitor from cohn fraction IV1 and IV4 paste |
| US5616693A (en) | 1996-07-01 | 1997-04-01 | Alpha Therapeutic Corporation | Process for seperating alpha-1-proteinase inhibitor from COHN IV1 +1V4 paste |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| CA2232420A1 (en) | 1997-03-19 | 1998-09-19 | The Green Cross Corporation | Immunoglobulin preparation and preparation process thereof |
| GB9705810D0 (en) * | 1997-03-20 | 1997-05-07 | Common Services Agency | Intravenous immune globulin |
| US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| CA2251342A1 (en) | 1997-10-23 | 1999-04-23 | Yutaka Hirao | Room temperature storable immunoglobulin preparation for intravenous injection |
| SE0001128D0 (sv) | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
| FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
| EP1413860A4 (en) * | 2001-07-05 | 2009-02-25 | Hamamatsu Photonics Kk | SPECTROSCOPIC DEVICE |
| 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 |
| DK1664123T4 (da) | 2003-09-22 | 2012-03-05 | Kamada Ltd | Storskalafremstilling af alfa-1-proteinaseinhibitor og anvendelse deraf |
| US20070244305A1 (en) | 2004-01-30 | 2007-10-18 | Suomen Punainen Risti Veripalvelu | Process for The Manufacture of Virus Safe Immunoglobulin |
| CA2557229C (en) | 2004-02-27 | 2012-07-10 | Octapharma Ag | A method of providing a purified, virus safe antibody preparation |
| US7807435B2 (en) | 2005-08-11 | 2010-10-05 | Baxter International Inc. | Method for the purification of alpha-1 proteinase inhibitor (a1PI) |
| ES2595059T3 (es) | 2007-03-20 | 2016-12-27 | Csl Behring Gmbh | Métodos para la producción a escala industrial de preparados terapéuticos del Factor H del complemento a partir de plasma humano |
| US8546548B2 (en) | 2009-05-27 | 2013-10-01 | Baxter International Inc. | Method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
| WO2011011753A1 (en) | 2009-07-23 | 2011-01-27 | Baxter International Inc. | Manufacture of factor h (fh) and fh-derivatives from plasma |
| AU2010202125B1 (en) * | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| US8772462B2 (en) * | 2010-05-26 | 2014-07-08 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| EP2596014B1 (en) | 2010-07-23 | 2018-11-28 | Baxalta GmbH | Manufacture of inter-alpha-inhibitor proteins (iaip) from plasma |
-
2013
- 2013-02-23 TW TW102106384A patent/TWI629283B/zh active
- 2013-02-25 SG SG11201405149UA patent/SG11201405149UA/en unknown
- 2013-02-25 WO PCT/US2013/027681 patent/WO2013126904A1/en not_active Ceased
- 2013-02-25 US US13/776,448 patent/US9782477B2/en active Active
- 2013-02-25 CA CA2864715A patent/CA2864715A1/en not_active Abandoned
- 2013-02-25 NZ NZ628529A patent/NZ628529A/en unknown
- 2013-02-25 MY MYPI2014002439A patent/MY167235A/en unknown
- 2013-02-25 EP EP22191464.1A patent/EP4119574A1/en active Pending
- 2013-02-25 CN CN201380020621.XA patent/CN104245730B/zh active Active
- 2013-02-25 DK DK13708051.1T patent/DK2817334T3/da active
- 2013-02-25 AU AU2013203112A patent/AU2013203112B2/en active Active
- 2013-02-25 BR BR112014020602-3A patent/BR112014020602B1/pt active IP Right Grant
- 2013-02-25 ES ES13708051T patent/ES2928954T3/es active Active
- 2013-02-25 HU HUE13708051A patent/HUE060195T2/hu unknown
- 2013-02-25 SI SI201332012T patent/SI2817334T1/sl unknown
- 2013-02-25 PL PL13708051.1T patent/PL2817334T3/pl unknown
- 2013-02-25 EP EP13708051.1A patent/EP2817334B1/en active Active
- 2013-02-25 EA EA201491564A patent/EA032478B1/ru not_active IP Right Cessation
- 2013-02-25 JP JP2014558931A patent/JP6291423B2/ja active Active
- 2013-02-25 AR ARP130100566A patent/AR090425A1/es not_active Application Discontinuation
- 2013-02-25 PT PT137080511T patent/PT2817334T/pt unknown
- 2013-02-25 KR KR1020147026210A patent/KR101930582B1/ko active Active
- 2013-02-25 MX MX2014010076A patent/MX365236B/es active IP Right Grant
-
2014
- 2014-08-13 IL IL23410314A patent/IL234103B/en active IP Right Grant
- 2014-08-21 CL CL2014002225A patent/CL2014002225A1/es unknown
- 2014-08-21 MX MX2019005999A patent/MX2019005999A/es unknown
- 2014-09-23 CO CO14210313A patent/CO7081143A2/es unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20160811 Address after: Aupu, Switzerland Applicant after: Hundred deep limited liability company Applicant after: Hundred deep company Address before: Illinois State Applicant before: Baxter International Inc. Applicant before: Bakst Helth Co., Ltd. |
|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP02 | Change in the address of a patent holder | ||
| CP02 | Change in the address of a patent holder |
Address after: Zug City Co-patentee after: Hundred deep company Patentee after: Hundred deep limited liability company Address before: Aupu, Switzerland Co-patentee before: Hundred deep company Patentee before: Hundred deep limited liability company |
|
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20210701 Address after: Osaka Patentee after: TAKEDA PHARMACEUTICAL Co.,Ltd. Address before: Zug City Patentee before: BAXALTA GmbH Patentee before: Baishen Co. |