TR200100303T2 - Damardan uygulanacak immünoglobülinler üretmek için yöntem ve başka immünoglobülin ürünleri. - Google Patents
Damardan uygulanacak immünoglobülinler üretmek için yöntem ve başka immünoglobülin ürünleri.Info
- Publication number
- TR200100303T2 TR200100303T2 TR2001/00303T TR200100303T TR200100303T2 TR 200100303 T2 TR200100303 T2 TR 200100303T2 TR 2001/00303 T TR2001/00303 T TR 2001/00303T TR 200100303 T TR200100303 T TR 200100303T TR 200100303 T2 TR200100303 T2 TR 200100303T2
- Authority
- TR
- Turkey
- Prior art keywords
- immunoglobulin
- iga
- exchange chromatography
- less
- relates
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title abstract 3
- 102000018358 immunoglobulin Human genes 0.000 title abstract 3
- 229940008228 intravenous immunoglobulins Drugs 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 abstract 4
- 108010088751 Albumins Proteins 0.000 abstract 1
- 102000009027 Albumins Human genes 0.000 abstract 1
- 239000008351 acetate buffer Substances 0.000 abstract 1
- 238000005571 anion exchange chromatography Methods 0.000 abstract 1
- 238000005277 cation exchange chromatography Methods 0.000 abstract 1
- 239000003599 detergent Substances 0.000 abstract 1
- 239000000539 dimer Substances 0.000 abstract 1
- 229940027941 immunoglobulin g Drugs 0.000 abstract 1
- 238000001990 intravenous administration Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 108010058237 plasma protein fraction Proteins 0.000 abstract 1
- 229940081857 plasma protein fraction Drugs 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
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
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Oncology (AREA)
- Virology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Bu bulus,immünoglobülin içeren bir ham plazma protein fraksiyonundan immünoglobülin G yi saflandirmak için bir yöntemle ilgilidir. Söz konusu yöntem, tercihen seri halinde bagli anyon degistirme kromatografisi ve katyon degistirme kromatografisinin de yer aldigi birkaç kademe ihtiva eder. Yönteminin tamaminda tercihen 5.0-6.0 lik bir pH'a ve 5-25 mM lik molariteye sahip bir asetat tamponu kullanilir. Bulus ayrica, bu yöntemle elde edilebilen ve %98 den yüksek safliga, %98.5 den fazla IgG monomeri ve dimeri muhtevasina, 4mg IgA/lt den az IgA muhtevasina sahip ve %0.5 den az polimer ve agregat içeren bir immünoglobülin ürünü ile ilgilidir. Bu ürün, stabilizör olarak deterjan, PEG veya albümin ihtiva etmez ve hemen damar içinden tatbik edilmek için hazir, kararli, virüs açisindan güvenli bir sividir.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98201909 | 1998-06-09 | ||
US10205598P | 1998-09-28 | 1998-09-28 |
Publications (1)
Publication Number | Publication Date |
---|---|
TR200100303T2 true TR200100303T2 (tr) | 2001-06-21 |
Family
ID=26150417
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
TR2001/00303T TR200100303T2 (tr) | 1998-06-09 | 1999-06-09 | Damardan uygulanacak immünoglobülinler üretmek için yöntem ve başka immünoglobülin ürünleri. |
Country Status (23)
Country | Link |
---|---|
EP (4) | EP1493751A1 (tr) |
JP (1) | JP5478519B2 (tr) |
KR (1) | KR100501263B1 (tr) |
CN (1) | CN1196714C (tr) |
AT (1) | ATE277950T1 (tr) |
AU (1) | AU753468B2 (tr) |
BR (1) | BR9911131A (tr) |
CA (1) | CA2330170C (tr) |
CZ (1) | CZ297199B6 (tr) |
DE (1) | DE69920693T2 (tr) |
DK (1) | DK1084147T3 (tr) |
ES (1) | ES2229784T3 (tr) |
HK (2) | HK1151044A1 (tr) |
HU (1) | HU228076B1 (tr) |
ID (1) | ID27417A (tr) |
IL (1) | IL140155A (tr) |
NZ (1) | NZ509135A (tr) |
PL (1) | PL196770B1 (tr) |
PT (1) | PT1084147E (tr) |
RU (1) | RU2197500C2 (tr) |
SK (1) | SK288128B6 (tr) |
TR (1) | TR200100303T2 (tr) |
WO (1) | WO1999064462A1 (tr) |
Families Citing this family (70)
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ES2158776B1 (es) * | 1999-04-13 | 2002-03-16 | Apc Europ S A | Procedimiento para la obtencion de gammaglobulinas de origen animal y aplicaciones correspondientes. |
AUPQ026799A0 (en) * | 1999-05-10 | 1999-06-03 | Csl Limited | Method of increasing protein stability by removing immunoglobulin aggregates |
EP1267905B1 (en) * | 2000-03-10 | 2005-09-28 | Medinnova As | Composition for the treatment of heart failure |
SE0001128D0 (sv) * | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
ES2184594B1 (es) * | 2001-01-17 | 2004-01-01 | Probitas Pharma Sa | Procedimiento para la produccion de gammaglobulina g humana inactivada de virus. |
FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
US20030223985A1 (en) * | 2002-05-29 | 2003-12-04 | The Lauridsen Group. Incorporated | Globulin protein to lower cholesterol in humans |
EP2261230B1 (en) | 2002-09-11 | 2017-05-10 | Chugai Seiyaku Kabushiki Kaisha | Protein purification method |
EP1614693A4 (en) * | 2003-03-31 | 2006-07-19 | Kirin Brewery | PURIFICATION OF A HUMAN MONOCLONAL ANTIBODY AND A HUMAN POLYCLONAL ANTIBODY |
EP1532983A1 (en) | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
MXPA06008435A (es) * | 2004-01-30 | 2007-05-23 | Suomen Punainen Risti Veripalvelu | Proceso de manufactura de una inmunoglobulina libre de virus. |
AU2005209360B2 (en) | 2004-01-30 | 2009-06-25 | Takeda Pharmaceutical Company Limited | Production and purification of recombinant arylsulfatase A |
AU2005229674B2 (en) * | 2004-11-18 | 2010-11-04 | Kedrion Melville Inc. | Low concentration solvent/detergent process of immuneglobulin with pre-treatment |
TWI391399B (zh) | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
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US9309316B2 (en) | 2005-12-20 | 2016-04-12 | Bristol-Myers Squibb Company | Stable subcutaneous protein formulations and uses thereof |
FR2895263B1 (fr) | 2005-12-26 | 2008-05-30 | Lab Francais Du Fractionnement | Concentre d'immunoglobines g (lg) appauvri en anticorps anti-a et anti-b, et en igg polyreactives |
DK2628746T3 (en) * | 2006-04-04 | 2019-04-01 | Chiesi Farm Spa | A method for the concentration of a polypeptide |
RU2303995C1 (ru) * | 2006-04-28 | 2007-08-10 | Халлар Абдумуслимович Алиханов | Средство, обладающее иммунорегуляторным свойством и его применение для лечения аутоиммунных заболеваний |
WO2008025748A1 (en) | 2006-08-28 | 2008-03-06 | Ares Trading S.A. | Process for the purification of fc-containing proteins |
DE102007001521A1 (de) * | 2007-01-10 | 2008-07-17 | Matthias, Torsten, Dr. | Verwendung von Cohn-Oncley-Fraktionen II und II/III zur Behandlung des systemischen Lupus erythematodes |
DK2215117T4 (en) | 2007-10-30 | 2018-04-09 | Genentech Inc | ANTISTO PURIFICATION BY CATION CHANGE CHROMATOGRAPHY |
US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
US8772461B2 (en) | 2008-04-15 | 2014-07-08 | Grifols Therapeutics Inc. | Two-stage ultrafiltration/diafiltration |
FR2939667B1 (fr) | 2008-12-17 | 2012-01-27 | Fractionnement Et Des Biotechonologies Lab Franc | Composition d'immunoglobine g comme medicament pour le traitement de l'ictere neonatal par incompatibilite foetomaternelle dans le systeme abo |
MY157239A (en) | 2009-05-27 | 2016-05-13 | Baxalta Inc | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
US20130116413A1 (en) * | 2009-12-29 | 2013-05-09 | Dr. Reddy's Laboratories, Inc. | Purification of proteins |
AU2011212440B2 (en) | 2010-02-04 | 2015-01-22 | Csl Behring Ag | Immunoglobulin preparation |
EP2361636A1 (en) * | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
RU2467783C2 (ru) * | 2010-07-30 | 2012-11-27 | Закрытое акционерное общество "БиоХимМак СТ" | Способ хроматографического выделения иммуноглобулина |
SG191781A1 (en) | 2010-12-30 | 2013-08-30 | Lab Francais Du Fractionnement | Glycols as pathogen inactivating agents |
ES2865449T3 (es) | 2011-03-16 | 2021-10-15 | Hoffmann La Roche | Cromatografía de intercambio iónico con selectividad mejorada para la separación de monómeros, agregados y fragmentos polipeptídicos por modulación de la fase móvil |
FR2974301B1 (fr) | 2011-04-20 | 2013-08-23 | Lab Francais Du Fractionnement | Procede de preparation d'un produit plasmatique deplete en un ou plusieurs facteurs thrombogenes |
IL212911A0 (en) * | 2011-05-16 | 2011-07-31 | Omrix Biopharmaceuticals Ltd | Immunoglobulin reduced in thrombogenic contaminants and preparation thereof |
ES2625511T3 (es) | 2011-07-08 | 2017-07-19 | Shire Human Genetic Therapies, Inc. | Métodos para la purificación de arylsulfatasa A |
MX349005B (es) * | 2011-08-26 | 2017-07-06 | Baxalta Inc | Metodo para reducir el potencial tromboembolico de una composicion de inmunoglobulina derivada de plasma. |
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MX369444B (es) | 2012-02-29 | 2019-11-08 | Baxalta Inc | REMIELINIZACION DE NERVIOS PERIFERICOS ESTIMULADA POR IgG. |
JP2015510875A (ja) | 2012-03-09 | 2015-04-13 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 分泌様免疫グロブリンを含む組成物 |
EP2636681A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Process for enriching IgA |
EP2636684A1 (en) | 2012-03-09 | 2013-09-11 | CSL Behring AG | Prevention of infection |
ES2381828B1 (es) * | 2012-03-20 | 2012-11-16 | Grifols, S.A. | PROCEDIMIENTO PARA OBTENER UNA COMPOSICION DE IgG MEDIANTE TRATAMIENTO TERMICO |
KR102065355B1 (ko) * | 2012-05-31 | 2020-01-13 | 에이전시 포 사이언스, 테크놀로지 앤드 리서치 | 단백질 제조물 내의 응집체 양 감소를 위한 혼합 다관능 표면들의 사용 방법 |
JP6297029B2 (ja) | 2012-05-31 | 2018-03-20 | エイジェンシー・フォー・サイエンス,テクノロジー・アンド・リサーチ | 多様な官能基を有する粒子による免疫グロブリンg調製物のクロマトグラフィー精製 |
EP2682168A1 (en) | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
MX2015008875A (es) | 2013-01-09 | 2015-10-22 | Shire Human Genetic Therapies | Metodos para la purificacion de arilsulfatasa a. |
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 |
WO2014186310A1 (en) | 2013-05-13 | 2014-11-20 | Momenta Pharmaceuticals, Inc. | Methods for the treatment of neurodegeneration |
DK3016976T3 (da) | 2013-07-01 | 2020-12-07 | Csl Behring Ag | Proces |
AU2014285971A1 (en) | 2013-07-05 | 2016-02-04 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Affinity chromatography matrix |
WO2015057622A1 (en) | 2013-10-16 | 2015-04-23 | Momenta Pharmaceuticals, Inc. | Sialylated glycoproteins |
CN103665100A (zh) * | 2014-01-03 | 2014-03-26 | 华兰生物工程重庆有限公司 | 低温乙醇提取静注人免疫球蛋白的方法 |
KR101917196B1 (ko) | 2014-03-11 | 2018-11-09 | 주식회사 녹십자홀딩스 | 면역글로불린의 정제방법 |
FR3018450B1 (fr) | 2014-03-11 | 2016-04-15 | Lab Francais Du Fractionnement | Procede de preparation de proteines plasmatiques humaines |
US10435670B2 (en) * | 2014-04-15 | 2019-10-08 | Boehringer Ingelheim International Gmbh | Methods, apparatuses, and systems for continuously inactivating a virus during manufacture of a biological product |
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 |
CN104356231B (zh) * | 2014-11-10 | 2017-08-08 | 北海开元生物科技有限公司 | 一种有效去除人免疫球蛋白多聚体的方法 |
US9556253B2 (en) | 2014-12-02 | 2017-01-31 | Hemarus Therapeutics Limited | Process for increased yield of immunoglobulin from human plasma |
FR3035971A1 (fr) | 2015-05-07 | 2016-11-11 | Lab Francais Du Fractionnement | Composition enrichie en immunoglobulines polyclonales anti-a et/ou anti-b |
KR101657690B1 (ko) * | 2015-06-05 | 2016-09-19 | 주식회사 녹십자홀딩스 | 혈장 유래 b형 간염 사람 면역글로불린 제제의 제조방법 |
CN105950576A (zh) * | 2016-05-26 | 2016-09-21 | 成都远睿生物技术有限公司 | 一种从牛血中提取多种蛋白的方法 |
CN107880116B (zh) * | 2016-09-30 | 2023-02-03 | 盖立复集团公司 | 用于制备免疫球蛋白的方法 |
FR3064484A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Composition d'immunoglobulines utiles pour traiter des infections virales |
FR3064486A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Prevention d'une infection par le virus respiratoire syncytial dans les voies respiratoires superieures |
FR3064485A1 (fr) | 2017-03-31 | 2018-10-05 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Traitement d'une infection par le virus respiratoire syncytial |
KR20190047376A (ko) | 2017-10-27 | 2019-05-08 | 주식회사 녹십자 | 개선된 면역글로불린의 정제방법 |
CN109776675A (zh) * | 2017-11-10 | 2019-05-21 | 北京博莱得利生物技术有限责任公司 | 两步离子交换层析法制备犬免疫球蛋白的方法 |
CN112574296B (zh) * | 2020-12-30 | 2023-05-19 | 中国医学科学院输血研究所 | 一种模拟IVIg的多人份混合人血浆IgG样品的分离纯化方法 |
KR20230148961A (ko) * | 2022-04-19 | 2023-10-26 | 에스케이플라즈마 주식회사 | 면역글로불린 정제방법 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2364792A1 (de) * | 1973-01-15 | 1974-07-18 | South African Inventions | Verfahren zum reinigen von gammaglobulin |
US4296027A (en) * | 1977-08-31 | 1981-10-20 | The Regents Of The University Of Minnesota | Pure intravenous human and animal gamma globulins |
US4314997A (en) | 1980-10-06 | 1982-02-09 | Edward Shanbrom | Purification of plasma protein products |
US4315919A (en) | 1980-10-06 | 1982-02-16 | Edward Shanbrom | Depyrogenation process |
US4764369A (en) | 1983-07-14 | 1988-08-16 | New York Blood Center Inc. | Undenatured virus-free biologically active protein derivatives |
NZ216094A (en) * | 1985-05-15 | 1989-06-28 | Commw Serum Lab Commission | Method for purification of an immunoglobulin |
DE4118912C1 (tr) * | 1991-06-08 | 1992-07-02 | Biotest Pharma Gmbh, 6072 Dreieich, De | |
FR2706466B1 (fr) * | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
-
1999
- 1999-06-09 AU AU42572/99A patent/AU753468B2/en not_active Expired
- 1999-06-09 RU RU2001101454/04A patent/RU2197500C2/ru active
- 1999-06-09 CZ CZ20004534A patent/CZ297199B6/cs not_active IP Right Cessation
- 1999-06-09 BR BR9911131-4A patent/BR9911131A/pt not_active Application Discontinuation
- 1999-06-09 PT PT99955389T patent/PT1084147E/pt unknown
- 1999-06-09 PL PL344671A patent/PL196770B1/pl unknown
- 1999-06-09 EP EP04077620A patent/EP1493751A1/en not_active Withdrawn
- 1999-06-09 KR KR10-2000-7014013A patent/KR100501263B1/ko not_active IP Right Cessation
- 1999-06-09 EP EP10184829.9A patent/EP2272870B1/en not_active Revoked
- 1999-06-09 AT AT99955389T patent/ATE277950T1/de active
- 1999-06-09 TR TR2001/00303T patent/TR200100303T2/tr unknown
- 1999-06-09 NZ NZ509135A patent/NZ509135A/xx not_active IP Right Cessation
- 1999-06-09 CN CNB998092819A patent/CN1196714C/zh not_active Expired - Lifetime
- 1999-06-09 WO PCT/DK1999/000312 patent/WO1999064462A1/en active IP Right Grant
- 1999-06-09 SK SK1866-2000A patent/SK288128B6/sk not_active IP Right Cessation
- 1999-06-09 DK DK99955389T patent/DK1084147T3/da active
- 1999-06-09 CA CA2330170A patent/CA2330170C/en not_active Expired - Fee Related
- 1999-06-09 ID IDW20010033A patent/ID27417A/id unknown
- 1999-06-09 ES ES99955389T patent/ES2229784T3/es not_active Expired - Lifetime
- 1999-06-09 DE DE69920693T patent/DE69920693T2/de not_active Expired - Lifetime
- 1999-06-09 IL IL14015599A patent/IL140155A/xx not_active IP Right Cessation
- 1999-06-09 EP EP10011725.8A patent/EP2270044B1/en not_active Revoked
- 1999-06-09 EP EP99955389A patent/EP1084147B1/en not_active Revoked
- 1999-06-09 HU HU0101988A patent/HU228076B1/hu unknown
-
2011
- 2011-01-07 JP JP2011001813A patent/JP5478519B2/ja not_active Expired - Lifetime
- 2011-05-24 HK HK11105137.0A patent/HK1151044A1/xx unknown
- 2011-05-24 HK HK11105138.9A patent/HK1151045A1/xx unknown
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