SI9420008B - Postopek za izdelavo koncentrata anti-D imunoglobulina G in farmacevtski pripravek ,ki ga vsebuje - Google Patents
Postopek za izdelavo koncentrata anti-D imunoglobulina G in farmacevtski pripravek ,ki ga vsebuje Download PDFInfo
- Publication number
- SI9420008B SI9420008B SI9420008A SI9420008A SI9420008B SI 9420008 B SI9420008 B SI 9420008B SI 9420008 A SI9420008 A SI 9420008A SI 9420008 A SI9420008 A SI 9420008A SI 9420008 B SI9420008 B SI 9420008B
- Authority
- SI
- Slovenia
- Prior art keywords
- igg
- plasma
- adsorbent
- process according
- composition
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 19
- 239000000825 pharmaceutical preparation Substances 0.000 title claims 2
- 239000012141 concentrate Substances 0.000 title abstract 2
- 239000003463 adsorbent Substances 0.000 claims abstract 11
- 238000004255 ion exchange chromatography Methods 0.000 claims abstract 4
- 230000000694 effects Effects 0.000 claims abstract 3
- 125000000524 functional group Chemical group 0.000 claims abstract 3
- 238000005342 ion exchange Methods 0.000 claims abstract 3
- 238000005406 washing Methods 0.000 claims abstract 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract 2
- 229940027941 immunoglobulin g Drugs 0.000 claims abstract 2
- 239000000203 mixture Substances 0.000 claims 7
- 241000700605 Viruses Species 0.000 claims 5
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 239000003599 detergent Substances 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 239000004471 Glycine Substances 0.000 claims 2
- 108091005804 Peptidases Proteins 0.000 claims 2
- 239000004365 Protease Substances 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 238000010828 elution Methods 0.000 claims 2
- 230000002779 inactivation Effects 0.000 claims 2
- 238000011534 incubation Methods 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 230000001105 regulatory effect Effects 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000007858 starting material Substances 0.000 claims 2
- 102000035195 Peptidases Human genes 0.000 claims 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims 1
- 229940024546 aluminum hydroxide gel Drugs 0.000 claims 1
- SMYKVLBUSSNXMV-UHFFFAOYSA-K aluminum;trihydroxide;hydrate Chemical compound O.[OH-].[OH-].[OH-].[Al+3] SMYKVLBUSSNXMV-UHFFFAOYSA-K 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 238000004440 column chromatography Methods 0.000 claims 1
- -1 diethylaminoethyl groups Chemical group 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 230000008014 freezing Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 230000000415 inactivating effect Effects 0.000 claims 1
- 238000011140 membrane chromatography Methods 0.000 claims 1
- 238000001728 nano-filtration Methods 0.000 claims 1
- 238000005191 phase separation Methods 0.000 claims 1
- 238000001179 sorption measurement Methods 0.000 claims 1
- 238000010257 thawing Methods 0.000 claims 1
- STCOOQWBFONSKY-UHFFFAOYSA-N tributyl phosphate Chemical compound CCCCOP(=O)(OCCCC)OCCCC STCOOQWBFONSKY-UHFFFAOYSA-N 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 abstract 1
- 230000002458 infectious effect Effects 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
- 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
-
- 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
-
- 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
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/34—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood group antigens
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (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)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP93810912A EP0659767B2 (de) | 1993-12-27 | 1993-12-27 | Verfahren zur Herstellung eines Konzentrates von Anti-D-Immunoglobulin G und pharmazeutische Zusammensetzung, die dieses enthält |
| PCT/EP1994/004267 WO1995018155A1 (en) | 1993-12-27 | 1994-12-22 | Method of producing a concentrate of anti-d immunoglobulin g and pharmaceutical preparation which contains it |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI9420008A SI9420008A (en) | 1996-02-29 |
| SI9420008B true SI9420008B (sl) | 1998-06-30 |
Family
ID=8215103
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9420008A SI9420008B (sl) | 1993-12-27 | 1994-12-22 | Postopek za izdelavo koncentrata anti-D imunoglobulina G in farmacevtski pripravek ,ki ga vsebuje |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US5593675A (cs) |
| EP (1) | EP0659767B2 (cs) |
| JP (1) | JP2926463B2 (cs) |
| KR (1) | KR100368563B1 (cs) |
| AT (1) | ATE175979T1 (cs) |
| AU (1) | AU682243B2 (cs) |
| CA (1) | CA2138921C (cs) |
| CZ (1) | CZ286271B6 (cs) |
| DE (1) | DE59309332D1 (cs) |
| DK (1) | DK0659767T4 (cs) |
| ES (1) | ES2129076T5 (cs) |
| FI (1) | FI112168B (cs) |
| GR (1) | GR3029817T3 (cs) |
| HU (1) | HU216864B (cs) |
| NO (1) | NO315331B1 (cs) |
| NZ (1) | NZ278057A (cs) |
| PL (1) | PL180358B1 (cs) |
| SI (1) | SI9420008B (cs) |
| TW (1) | TW311884B (cs) |
| WO (1) | WO1995018155A1 (cs) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999057134A1 (en) * | 1998-05-06 | 1999-11-11 | Genentech, Inc. | Protein purification by ion exchange chromatography |
| JP4685238B2 (ja) * | 1998-06-09 | 2011-05-18 | ツエー・エス・エル・ベーリング・アクチエンゲゼルシヤフト | 静脈投与用免疫グロブリン及び他の免疫グロブリン生成物の製造法 |
| DE19923027C2 (de) * | 1999-05-19 | 2002-09-19 | Aventis Behring Gmbh | Verfahren zur Inaktivierung von Viren |
| US6475749B1 (en) * | 1999-08-11 | 2002-11-05 | The Regents Of The University Of California | Rh hybrid antibody |
| 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. |
| EP1532983A1 (en) * | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
| CA2458750C (en) | 2004-02-23 | 2012-02-07 | Bayer Inc. | Isoolefin-diolefin production process and apparatus therefor |
| US20060263357A1 (en) * | 2005-05-05 | 2006-11-23 | Tedder Thomas F | Anti-CD19 antibody therapy for autoimmune disease |
| TWI391399B (zh) | 2005-05-25 | 2013-04-01 | Hoffmann La Roche | 測定溶離多肽之鹽濃度之方法 |
| EA017733B1 (ru) * | 2006-08-28 | 2013-02-28 | Арес Трейдинг С.А. | СПОСОБ ОЧИСТКИ Fc-СЛИТЫХ БЕЛКОВ |
| WO2008025748A1 (en) * | 2006-08-28 | 2008-03-06 | Ares Trading S.A. | Process for the purification of fc-containing proteins |
| 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. |
| JP6078344B2 (ja) | 2010-02-04 | 2017-02-08 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 免疫グロブリン製剤 |
| EP2361636A1 (en) | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| RU2467783C2 (ru) * | 2010-07-30 | 2012-11-27 | Закрытое акционерное общество "БиоХимМак СТ" | Способ хроматографического выделения иммуноглобулина |
| EA027353B1 (ru) * | 2010-09-17 | 2017-07-31 | Баксалта Инкорпорейтид | СТАБИЛИЗАЦИЯ ИММУНОГЛОБУЛИНОВ С ПОМОЩЬЮ ВОДНОГО СОСТАВА С ГИСТИДИНОМ ПРИ pH ОТ СЛАБОКИСЛОГО ДО НЕЙТРАЛЬНОГО |
| CN103874708B (zh) | 2011-08-26 | 2018-07-10 | 百深有限责任公司 | 用于降低血浆来源免疫球蛋白组合物的血栓栓塞可能性的方法 |
| 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 |
| US10287315B2 (en) * | 2014-03-11 | 2019-05-14 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
| KR101917197B1 (ko) * | 2014-03-11 | 2018-11-09 | 주식회사 녹십자홀딩스 | 면역글로불린의 정제방법 |
| CN106999588A (zh) | 2014-12-03 | 2017-08-01 | 瑞士杰特贝林生物制品有限公司 | 具有增加的稳定性的包含免疫球蛋白的药物产品 |
| MA52945A (fr) * | 2018-06-22 | 2021-04-28 | Genmab As | Procédé de production d'un mélange contrôlé d'au moins deux anticorps différents |
| EP4349859A1 (en) * | 2023-01-27 | 2024-04-10 | CSL Behring AG | Method to purify anti-d immunoglobulin g from plasma |
| WO2024156861A1 (en) * | 2023-01-27 | 2024-08-02 | Csl Behring Ag | Method for reducing protease activity in a solution comprising anti-d immunoglobulin g |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3869436A (en) * | 1971-06-01 | 1975-03-04 | Statens Bakteriologiska Lab | Method for fractionating plasma proteins using peg and ion-exchangers |
| ATE19735T1 (de) * | 1982-02-08 | 1986-05-15 | Schweiz Serum & Impfinst | Intravenoes verabreichbares humanes immunglobulin und verfahren zu dessen herstellung. |
| US4434093A (en) * | 1982-07-26 | 1984-02-28 | Ortho Diagnostic Systems Inc. | Methods for preparation of HBs Ag free gamma globulins |
| DE3640513A1 (de) * | 1986-11-27 | 1988-06-09 | Biotest Pharma Gmbh | Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates |
| US5118796A (en) * | 1987-12-09 | 1992-06-02 | Centocor, Incorporated | Efficient large-scale purification of immunoglobulins and derivatives |
| US5138034A (en) * | 1989-07-12 | 1992-08-11 | The Green Cross Corporation | Method of fractionating plasma proteins |
| US5177194A (en) * | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
-
1993
- 1993-12-27 EP EP93810912A patent/EP0659767B2/de not_active Expired - Lifetime
- 1993-12-27 ES ES93810912T patent/ES2129076T5/es not_active Expired - Lifetime
- 1993-12-27 AT AT93810912T patent/ATE175979T1/de active
- 1993-12-27 DE DE59309332T patent/DE59309332D1/de not_active Expired - Lifetime
- 1993-12-27 DK DK93810912T patent/DK0659767T4/da active
-
1994
- 1994-12-21 US US08/360,334 patent/US5593675A/en not_active Expired - Lifetime
- 1994-12-22 CA CA002138921A patent/CA2138921C/en not_active Expired - Fee Related
- 1994-12-22 SI SI9420008A patent/SI9420008B/sl unknown
- 1994-12-22 CZ CZ19952492A patent/CZ286271B6/cs not_active IP Right Cessation
- 1994-12-22 PL PL94310435A patent/PL180358B1/pl not_active IP Right Cessation
- 1994-12-22 KR KR1019950703644A patent/KR100368563B1/ko not_active Expired - Fee Related
- 1994-12-22 HU HU9502514A patent/HU216864B/hu not_active IP Right Cessation
- 1994-12-22 AU AU14143/95A patent/AU682243B2/en not_active Ceased
- 1994-12-22 NZ NZ278057A patent/NZ278057A/en not_active IP Right Cessation
- 1994-12-22 WO PCT/EP1994/004267 patent/WO1995018155A1/en not_active Ceased
- 1994-12-23 NO NO19945032A patent/NO315331B1/no not_active IP Right Cessation
- 1994-12-27 JP JP6337017A patent/JP2926463B2/ja not_active Expired - Fee Related
- 1994-12-27 FI FI946103A patent/FI112168B/fi not_active IP Right Cessation
-
1995
- 1995-01-10 TW TW084100147A patent/TW311884B/zh not_active IP Right Cessation
-
1999
- 1999-03-30 GR GR990400907T patent/GR3029817T3/el unknown
Also Published As
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| IF | Valid on the event date | ||
| SP73 | Change of data on owner |
Owner name: ZLB BEHRING AG; CH Effective date: 20050707 |
|
| SP73 | Change of data on owner |
Owner name: CSL BEHRING AG; CH Effective date: 20070913 |