EA201990392A1 - Процесс получения композиций иммуноглобулинов - Google Patents
Процесс получения композиций иммуноглобулиновInfo
- Publication number
- EA201990392A1 EA201990392A1 EA201990392A EA201990392A EA201990392A1 EA 201990392 A1 EA201990392 A1 EA 201990392A1 EA 201990392 A EA201990392 A EA 201990392A EA 201990392 A EA201990392 A EA 201990392A EA 201990392 A1 EA201990392 A1 EA 201990392A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- immunoglobulin
- igg
- enriched
- compositions
- igm
- Prior art date
Links
Classifications
-
- 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
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- General Physics & Mathematics (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Pathology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
Настоящее изобретение относится к способу получения фармацевтически приемлемых композиций иммуноглобулинов из полученных из плазмы фракций иммуноглобулинов, позволяющему параллельное получение композиций иммуноглобулинов, обогащенных IgG, IgM и IgA. По этому способу иммуноглобулин, содержащийся в фракции Кона I/II/III или фракции Кистлера/Нитшманна A+I, ресолюбилизируют при проводимости по меньшей мере 1 мСм/см и после удаления загрязняющего белка ресолюбилизированный иммуноглобулин подвергают анионообменной хроматографии для получения обогащенных IgG и IgM/IgA композиций иммуноглобулинов. Обогащенную IgG композицию иммуноглобулинов дополнительно подвергают обработке с использованием катионообменного материала для получения композиции иммуноглобулинов, имеющей уменьшенное содержание пропердина.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16181493.4A EP3275897A1 (en) | 2016-07-27 | 2016-07-27 | Process for preparing immunoglobulin compositions |
PCT/EP2017/068914 WO2018019898A1 (en) | 2016-07-27 | 2017-07-26 | Process for preparing immunoglobulin compositions |
Publications (1)
Publication Number | Publication Date |
---|---|
EA201990392A1 true EA201990392A1 (ru) | 2019-07-31 |
Family
ID=56555240
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201990392A EA201990392A1 (ru) | 2016-07-27 | 2017-07-26 | Процесс получения композиций иммуноглобулинов |
Country Status (10)
Country | Link |
---|---|
US (2) | US11325964B2 (ru) |
EP (2) | EP3275897A1 (ru) |
JP (1) | JP7073333B2 (ru) |
CN (1) | CN109641950B (ru) |
AU (1) | AU2017302006B2 (ru) |
BR (1) | BR112019000736A2 (ru) |
CA (1) | CA3031462A1 (ru) |
EA (1) | EA201990392A1 (ru) |
MA (1) | MA45768A (ru) |
WO (1) | WO2018019898A1 (ru) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20160257754A1 (en) | 2013-10-16 | 2016-09-08 | Momenta Pharmaceuticals Inc. | Sialylated glycoproteins |
CN109575129B (zh) * | 2018-12-29 | 2022-04-26 | 贵州泰邦生物制品有限公司 | 一种静注人免疫球蛋白的制备工艺 |
KR20230024885A (ko) * | 2020-04-10 | 2023-02-21 | 플라즈마 테크놀로지스, 엘엘씨 | 간소화된 고효율 단백질 단리를 위한 조성물 및 방법 (compositions and methods for simplified high efficiency isolation of proteins) |
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 |
AU2022317368A1 (en) * | 2021-07-29 | 2024-02-22 | Csl Behring Ag | Method of purifying immunoglobulin g and uses thereof |
Family Cites Families (31)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
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 |
SU1137098A1 (ru) * | 1983-07-21 | 1985-01-30 | Московская ветеринарная академия им.К.И.Скрябина | Способ выделени пропердина из сыворотки крови |
IL90281A (en) | 1988-06-06 | 1994-10-07 | Miles Inc | Preparations containing MGI antibodies |
DE3825429C2 (de) | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt |
DE3927112C1 (ru) | 1989-08-17 | 1990-10-25 | Biotest Pharma Gmbh, 6072 Dreieich, De | |
DE3927111C3 (de) | 1989-08-17 | 1994-09-01 | Biotest Pharma Gmbh | Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate |
ATE122054T1 (de) | 1990-03-22 | 1995-05-15 | Biotest Pharma Gmbh | Verfahren zur herstellung eines intravenös verträglichen immunglobulin-g-präparates. |
US5256771A (en) | 1990-04-03 | 1993-10-26 | Miles Inc. | Heat treatment of IgM-containing immunoglobulins to eliminate non-specific complement activation |
FI952196A0 (fi) | 1995-05-08 | 1995-05-08 | Suomen Punainen Risti Veripalv | Framstaellning av immunoglobulin |
TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
ATE335511T1 (de) * | 1997-08-26 | 2006-09-15 | Amgen Fremont Inc | Ein verfahren zur inhibierung der komplementaktivierung über einen alternativen weg |
US5854051A (en) * | 1997-09-15 | 1998-12-29 | Heska Corporation | Parasitic helminth asparaginase proteins, nucleic acid molecules, and uses thereof |
ES2527915T3 (es) * | 1998-06-09 | 2015-02-02 | Csl Behring Ag | Producto de inmunoglobulina G (IgG) líquido |
AU753468B2 (en) * | 1998-06-09 | 2002-10-17 | Csl Behring Ag | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
FR2824568B1 (fr) * | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
US6593744B2 (en) * | 2001-11-20 | 2003-07-15 | Koninklijke Philips Electronics, N.V. | Multi-channel RF cable trap for magnetic resonance apparatus |
SG176256A1 (en) * | 2009-05-27 | 2012-01-30 | Baxter Int | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
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. |
GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
AU2010202125B1 (en) * | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
IL212911A0 (en) * | 2011-05-16 | 2011-07-31 | Omrix Biopharmaceuticals Ltd | Immunoglobulin reduced in thrombogenic contaminants and preparation thereof |
KR20140064768A (ko) * | 2011-07-01 | 2014-05-28 | 더 트러스티스 오브 더 유니버시티 오브 펜실바니아 | 항-프로퍼딘 항체 및 그의 용도 |
AR087953A1 (es) * | 2011-08-26 | 2014-04-30 | Baxter Int | Metodo para reducir el potencial tromboembolico de una composicion de inmunoglobulina derivada de plasma |
SG10201701224UA (en) * | 2012-03-12 | 2017-04-27 | Merck Patent Gmbh | Removal of protein aggregates from biopharmaceutical preparations in a flowthrough mode |
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 |
CN105358571B (zh) * | 2013-07-01 | 2019-03-05 | 瑞士杰特贝林生物制品有限公司 | 方法 |
FR3018450B1 (fr) * | 2014-03-11 | 2016-04-15 | Lab Francais Du Fractionnement | Procede de preparation de proteines plasmatiques humaines |
ES2769783T3 (es) * | 2014-03-11 | 2020-06-29 | Green Cross Holdings Corp | Procedimiento de purificación de inmunoglobulina |
CN104402993B (zh) * | 2014-11-28 | 2017-01-04 | 贵州泰邦生物制品有限公司 | 一种制备静注人免疫球蛋白的方法 |
-
2016
- 2016-07-27 EP EP16181493.4A patent/EP3275897A1/en not_active Withdrawn
-
2017
- 2017-07-26 BR BR112019000736-9A patent/BR112019000736A2/pt unknown
- 2017-07-26 AU AU2017302006A patent/AU2017302006B2/en active Active
- 2017-07-26 CA CA3031462A patent/CA3031462A1/en active Pending
- 2017-07-26 MA MA045768A patent/MA45768A/fr unknown
- 2017-07-26 WO PCT/EP2017/068914 patent/WO2018019898A1/en unknown
- 2017-07-26 JP JP2019504003A patent/JP7073333B2/ja active Active
- 2017-07-26 EP EP17742268.0A patent/EP3491018A1/en active Pending
- 2017-07-26 EA EA201990392A patent/EA201990392A1/ru unknown
- 2017-07-26 CN CN201780052839.1A patent/CN109641950B/zh active Active
- 2017-07-26 US US16/320,900 patent/US11325964B2/en active Active
-
2022
- 2022-04-08 US US17/716,674 patent/US20220227841A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
AU2017302006B2 (en) | 2024-07-25 |
MA45768A (fr) | 2019-06-05 |
EP3275897A1 (en) | 2018-01-31 |
US20190161533A1 (en) | 2019-05-30 |
US20220227841A1 (en) | 2022-07-21 |
WO2018019898A1 (en) | 2018-02-01 |
US11325964B2 (en) | 2022-05-10 |
CN109641950A (zh) | 2019-04-16 |
BR112019000736A2 (pt) | 2019-05-07 |
EP3491018A1 (en) | 2019-06-05 |
JP2019525933A (ja) | 2019-09-12 |
AU2017302006A1 (en) | 2019-01-24 |
CN109641950B (zh) | 2023-06-02 |
CA3031462A1 (en) | 2018-02-01 |
JP7073333B2 (ja) | 2022-05-23 |
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