TR201905974T4 - İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem - Google Patents
İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem Download PDFInfo
- Publication number
- TR201905974T4 TR201905974T4 TR2019/05974T TR201905974T TR201905974T4 TR 201905974 T4 TR201905974 T4 TR 201905974T4 TR 2019/05974 T TR2019/05974 T TR 2019/05974T TR 201905974 T TR201905974 T TR 201905974T TR 201905974 T4 TR201905974 T4 TR 201905974T4
- Authority
- TR
- Turkey
- Prior art keywords
- solution
- solution obtained
- immunoglobulin
- preparing
- starting
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title abstract 3
- 102000018358 immunoglobulin Human genes 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 2
- 229940072221 immunoglobulins Drugs 0.000 title 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 abstract 2
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 abstract 2
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 abstract 1
- 239000004721 Polyphenylene oxide Substances 0.000 abstract 1
- 241000700605 Viruses Species 0.000 abstract 1
- 238000011026 diafiltration Methods 0.000 abstract 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 abstract 1
- 230000002779 inactivation Effects 0.000 abstract 1
- 229960002446 octanoic acid Drugs 0.000 abstract 1
- 229920000570 polyether Polymers 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 238000000108 ultra-filtration Methods 0.000 abstract 1
Classifications
-
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- 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
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/24011—Flaviviridae
- C12N2770/24311—Pestivirus, e.g. bovine viral diarrhea virus
- C12N2770/24361—Methods of inactivation or attenuation
- C12N2770/24363—Methods of inactivation or attenuation by chemical treatment
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Mycology (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- General Engineering & Computer Science (AREA)
- Virology (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
Mevcut buluş, bir polieter veya glikol polimerinin varlığında %96'dan büyük veya ona eşit bir saflığa sahip bir immünoglobulin başlangıç çözeltisine dayanan bir immünoglobulin çözeltisinin hazırlanması için bir yöntemle ilgili olup ayırt edici özelliği şu adımları ihtiva etmesidir: a) başlangıç çözeltisine kaprilik asit veya bunun tuzlarının eklenmesi; b) a) adımında elde edilen çözeltinin pH'ının ayarlanması; c) b) adımında elde edilen çözeltinin zarflı virüslerin inaktivasyonu için gerekli süre kadar ve sıcaklıkta inkübe edilmesi; d) c) adımında elde edilen çözelti üzerinde ultrafiltrasyon/diyafiltrasyon adımının gerçekleştirilmesi.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ES201531243 | 2015-08-31 |
Publications (1)
Publication Number | Publication Date |
---|---|
TR201905974T4 true TR201905974T4 (tr) | 2019-05-21 |
Family
ID=55646274
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TR2019/05974T TR201905974T4 (tr) | 2015-08-31 | 2016-03-10 | İmmünoglobuli̇nleri̇n hazirlanmasi i̇çi̇n yöntem |
Country Status (8)
Country | Link |
---|---|
US (1) | US10358462B2 (tr) |
EP (1) | EP3135687B1 (tr) |
ES (1) | ES2721311T3 (tr) |
HU (1) | HUE042984T2 (tr) |
MY (1) | MY181270A (tr) |
PL (1) | PL3135687T3 (tr) |
PT (1) | PT3135687T (tr) |
TR (1) | TR201905974T4 (tr) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3638693A4 (en) | 2017-06-12 | 2021-04-14 | Kamada Ltd | IMMUNOGLOBULIN COMPOSITIONS AND PROCESS FOR THEIR PREPARATION |
RU2728724C2 (ru) * | 2018-09-13 | 2020-07-30 | Акционерное общество "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" | Способ получения вирусбезопасного раствора иммуноглобулина g человека для внутримышечного введения |
WO2021244910A1 (en) * | 2020-06-03 | 2021-12-09 | Grifols Worldwide Operations Limited | Hyperimmune igg and/or igm compositions and method for preparing thereof and method for obtaining hyperimmune human plasma from a donor |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4164495A (en) * | 1976-04-06 | 1979-08-14 | Nordisk Insulinlaboratorium | Method of recovering immunoglobulin using a polyol and an alkanoic acid |
JPS5874617A (ja) | 1981-10-28 | 1983-05-06 | Green Cross Corp:The | 人由来血液凝固第7因子含有水溶液の加熱処理方法 |
DE3641115A1 (de) * | 1986-12-02 | 1988-06-16 | Lentia Gmbh | Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins |
US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
US6281336B1 (en) * | 1998-06-09 | 2001-08-28 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
ES2184594B1 (es) | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
JP2008500959A (ja) | 2004-01-30 | 2008-01-17 | スオメン プナイネン リスティ ヴェリパルヴェル | ウイルスについて安全な免疫グロブリンの製造方法 |
EP1718675B2 (en) | 2004-02-27 | 2017-01-25 | Octapharma AG | A method of providing a purified, virus safe antibody preparation |
ES2381828B1 (es) * | 2012-03-20 | 2012-11-16 | Grifols, S.A. | PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO |
US10508133B2 (en) * | 2013-10-18 | 2019-12-17 | Novasep Process | Purification of proteins |
US10738078B2 (en) * | 2014-11-03 | 2020-08-11 | Bristol-Myers Squibb Company | Use of caprylic acid precipitation for protein purification |
-
2016
- 2016-03-10 PT PT16159748T patent/PT3135687T/pt unknown
- 2016-03-10 HU HUE16159748A patent/HUE042984T2/hu unknown
- 2016-03-10 EP EP16159748.9A patent/EP3135687B1/en active Active
- 2016-03-10 ES ES16159748T patent/ES2721311T3/es active Active
- 2016-03-10 TR TR2019/05974T patent/TR201905974T4/tr unknown
- 2016-03-10 PL PL16159748T patent/PL3135687T3/pl unknown
- 2016-09-26 US US15/276,544 patent/US10358462B2/en active Active
- 2016-09-26 MY MYPI2016703519A patent/MY181270A/en unknown
Also Published As
Publication number | Publication date |
---|---|
PT3135687T (pt) | 2019-05-21 |
MY181270A (en) | 2020-12-21 |
HUE042984T2 (hu) | 2019-07-29 |
EP3135687B1 (en) | 2019-04-10 |
ES2721311T3 (es) | 2019-07-30 |
EP3135687A1 (en) | 2017-03-01 |
US20170198009A1 (en) | 2017-07-13 |
PL3135687T3 (pl) | 2019-09-30 |
US10358462B2 (en) | 2019-07-23 |
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