HRP20161693T1 - Završno filtriranje imunoglobulina u više koraka - Google Patents
Završno filtriranje imunoglobulina u više koraka Download PDFInfo
- Publication number
- HRP20161693T1 HRP20161693T1 HRP20161693TT HRP20161693T HRP20161693T1 HR P20161693 T1 HRP20161693 T1 HR P20161693T1 HR P20161693T T HRP20161693T T HR P20161693TT HR P20161693 T HRP20161693 T HR P20161693T HR P20161693 T1 HRP20161693 T1 HR P20161693T1
- Authority
- HR
- Croatia
- Prior art keywords
- filter
- immunoglobulin
- pore size
- immunoglobulin solution
- solution
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title claims 17
- 102000018358 immunoglobulin Human genes 0.000 title claims 17
- 238000001914 filtration Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 9
- 239000011148 porous material Substances 0.000 claims 8
- 238000011045 prefiltration Methods 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000000746 purification Methods 0.000 claims 2
- 238000001042 affinity chromatography Methods 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 238000005571 anion exchange chromatography Methods 0.000 claims 1
- 238000005277 cation exchange chromatography Methods 0.000 claims 1
- 238000009295 crossflow filtration Methods 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 239000003599 detergent Substances 0.000 claims 1
- 238000011026 diafiltration Methods 0.000 claims 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 1
- 230000016784 immunoglobulin production Effects 0.000 claims 1
- 229940072221 immunoglobulins Drugs 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 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
-
- 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
-
- 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
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Oncology (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Fats And Perfumes (AREA)
Claims (9)
1. Postupak proizvodnje otopine imunoglobulina, naznačen time, da obuhvaća sljedeće korake:
a) pripremanje otopine imunoglobulina s koncentracijom od najmanje 100 g/l;
b) nanošenje otopine imunoglobulina na kombinaciju prve i druge filterske jedinice, pri čemu prva filterska jedinica sadrži predfilter s veličinom pora od 3,0 μm i glavni filter s veličinom pora od 0,8 μm, a druga filterska jedinica sadrži predfilter s veličinom pora od 0,45 μm i glavni filter s veličinom pora od 0,22 μm, s tlakom od 0,1 do 4,0 bara, te se time proizvodi otopina imunoglobulina.
2. Postupak proizvodnje imunoglobulina, naznačen time, da obuhvaća sljedeće korake:
a) kultiviranje stanice koja obuhvaća nukleinsku kiselinu koja kodira imunoglobulin;
b) dobivanje imunoglobulina iz stanice ili iz kultivacijskog medija;
c) pročišćivanje imunoglobulina kroz jednu ili više kromatografskih faza, te
pripremanje otopine imunoglobulina;
d) prema potrebi dodavanje šećera, aminokiseline i/ili deterdženta u otopinu;
e) koncentriranje otopine imunoglobulina na koncentraciju od 100 g/l ili više, putem postupka odabranog od diafiltriranja ili filtriranja tangencijalnim protokom; i
f) nanošenje otopine imunoglobulina iz prethodnog koraka, na kombinaciju
prve i druge filterske jedinice, pri čemu prva filterska jedinica sadrži predfilter s veličinom pora od 3,0 μm i glavni filter s veličinom pora od 0,8 μm, a druga filterska jedinica sadrži predfilter s veličinom pora od 0,45 μm i glavni gilter s veličinom pora od 0,22 μm, s tlakom od 0,1 do 4,0 bara, te se time proizvodi imunoglobulin.
3. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da filter u prvoj filterskoj jedinici ima istu filtersku površinu kao i filter u drugoj filterskoj jedinici.
4. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da otopina imunoglobulina ima koncentraciju od 100 g/l do 300 g/l.
5. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da otopina imunoglobulina ima volumen od tri litre do 100 litara.
6. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da imunoglobulin je protutijelo anti-IL13-receptora-alfa ili je protutijelo anti-HER2.
7. Postupak prema bilo kojem od zahtjeva 2 do 6, naznačen time, da se pročišćivanje vrši kroz fazu kromatografije afiniteta na protein-A i kroz najmanje jednu fazu odabranu od kromatografije kationske izmjene, kromatografije anionske izmjene i kromatografije hidrofobne interakcije.
8. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da otopina imunoglobulina ima koncentraciju od 160 g/l ili više, te se nanošenje na kombinaciju filtera vrši primjenom tlaka od 1,45 bara ili više.
9. Postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da otopina imunoglobulina sadrži šećer i tenzid i ima koncentraciju od 125 mg/ml ili više, te se nanošenje na kombinaciju filtera vrši primjenom tlaka od 0,75 bara ili manje.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09012460 | 2009-10-01 | ||
| EP10757795.9A EP2483305B1 (en) | 2009-10-01 | 2010-09-29 | Multistep final filtration of immunoglobulin |
| PCT/EP2010/064487 WO2011039274A1 (en) | 2009-10-01 | 2010-09-29 | Multistep final filtration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161693T1 true HRP20161693T1 (hr) | 2017-02-24 |
Family
ID=41466840
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161693TT HRP20161693T1 (hr) | 2009-10-01 | 2016-12-12 | Završno filtriranje imunoglobulina u više koraka |
| HRP20200588TT HRP20200588T1 (hr) | 2009-10-01 | 2020-04-14 | Završno filtriranje u više koraka |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200588TT HRP20200588T1 (hr) | 2009-10-01 | 2020-04-14 | Završno filtriranje u više koraka |
Country Status (21)
| Country | Link |
|---|---|
| US (4) | US20120231506A1 (hr) |
| EP (3) | EP3133083B1 (hr) |
| JP (1) | JP5458183B2 (hr) |
| KR (3) | KR101508044B1 (hr) |
| CN (3) | CN104610447A (hr) |
| AU (1) | AU2010302662B2 (hr) |
| BR (1) | BR112012004054B1 (hr) |
| CA (1) | CA2773674C (hr) |
| CY (1) | CY1118577T1 (hr) |
| DK (1) | DK2483305T3 (hr) |
| ES (2) | ES2787403T3 (hr) |
| HK (2) | HK1200178A1 (hr) |
| HR (2) | HRP20161693T1 (hr) |
| HU (1) | HUE030186T2 (hr) |
| IL (2) | IL217626A (hr) |
| LT (1) | LT2483305T (hr) |
| MX (1) | MX342442B (hr) |
| PL (2) | PL2483305T3 (hr) |
| PT (1) | PT2483305T (hr) |
| SI (2) | SI3133083T1 (hr) |
| WO (1) | WO2011039274A1 (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3769083A1 (en) | 2018-03-21 | 2021-01-27 | Waters Technologies Corporation | Non-antibody high-affinity-based sample preparation, sorbents, devices and methods |
| CN111007242A (zh) * | 2019-12-20 | 2020-04-14 | 苏州和迈精密仪器有限公司 | 基于多层高分子多孔膜的荧光免疫检测方法、装置及应用 |
Family Cites Families (30)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US5643566A (en) | 1982-09-23 | 1997-07-01 | Cetus Corporation | Formulation processes for lipophilic proteins |
| US4488961A (en) | 1982-09-29 | 1984-12-18 | E. I. Du Pont De Nemours And Company | One-way filter unit |
| US4592848A (en) | 1984-12-11 | 1986-06-03 | Pabst Richard E | Flow through filter with backflush clearing capability |
| CS247484B1 (cs) | 1985-04-12 | 1987-01-15 | Eva Hamsikova | Způsob přípravy imunoglobulinu proti lidským Iymfocytům |
| JP3040121B2 (ja) | 1988-01-12 | 2000-05-08 | ジェネンテク，インコーポレイテッド | 増殖因子レセプターの機能を阻害することにより腫瘍細胞を処置する方法 |
| DE3818860A1 (de) | 1988-06-03 | 1989-12-07 | Seitz Filter Werke | Filterelement |
| JP4124480B2 (ja) | 1991-06-14 | 2008-07-23 | ジェネンテック・インコーポレーテッド | 免疫グロブリン変異体 |
| DE4204444C1 (hr) | 1992-02-14 | 1993-05-19 | Krankenhausentsorgungs Gmbh, 1000 Berlin, De | |
| DK1516628T3 (da) | 1995-07-27 | 2013-09-08 | Genentech Inc | Stabil, isotonisk lyofiliseret proteinformulering |
| ES2335365T3 (es) | 1996-11-27 | 2010-03-25 | Genentech, Inc. | Purificacion por afinidad de polipeptido en una matriz de proteina a. |
| DE69907439T3 (de) | 1998-05-06 | 2014-01-02 | Genentech, Inc. | Reinigung von proteinen durch ionenaustauschchromatographie |
| US6984494B2 (en) * | 2000-08-15 | 2006-01-10 | Genentech, Inc. | Analytical method |
| DE60325334D1 (de) | 2002-02-05 | 2009-01-29 | Genentech Inc | Proteinaufreinigung |
| AU2003251592A1 (en) * | 2002-06-21 | 2004-01-06 | Biogen Idec Inc. | Buffered formulations for concentrating antibodies and methods of use thereof |
| KR20050048666A (ko) * | 2002-10-04 | 2005-05-24 | 기린 비루 가부시키가이샤 | 인간 인공 염색체(ｈａｃ) 벡터 |
| JPWO2004087761A1 (ja) | 2003-03-31 | 2006-07-27 | 麒麟麦酒株式会社 | ヒトモノクローナル抗体およびヒトポリクローナル抗体の精製 |
| GB0316560D0 (en) * | 2003-07-15 | 2003-08-20 | Chiron Srl | Vesicle filtration |
| CA2567814C (en) * | 2004-05-27 | 2013-07-23 | Jon A. Weidanz | Antibodies as t cell receptor mimics, methods of production and uses thereof |
| PT1786273T (pt) * | 2004-08-20 | 2019-02-19 | The American Nat Red Cross | Esquemas de isolamento e purificação de proteínas sequenciais por cromatografia de afinidade |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| US20080247949A1 (en) * | 2004-11-22 | 2008-10-09 | Oxygenix Co., Ltd. | Biological Tissue Examination Agent Comprising Hemoglobin Labeled With Oxygen Isotope And Method For Producing The Same |
| TW200902555A (en) | 2005-01-03 | 2009-01-16 | Hoffmann La Roche | Antibodies against IL-13 receptor alpha 1 and uses thereof |
| NZ560844A (en) * | 2005-03-08 | 2008-08-29 | Pharmacia & Upjohn Co Llc | Anti-MAdCAM antibody compositions |
| WO2007018316A1 (ja) | 2005-08-09 | 2007-02-15 | Takeda Pharmaceutical Company Limited | 癌の予防・治療剤 |
| EP2078039B1 (en) * | 2006-11-01 | 2017-09-13 | Biogen MA Inc. | Method of isolating biomacromolecules using low ph and divalent cations |
| JP5432137B2 (ja) * | 2007-07-17 | 2014-03-05 | エフ．ホフマン−ラ ロシュ アーゲー | 可変的タンジェンシャルフロー濾過 |
| AR067536A1 (es) | 2007-07-17 | 2009-10-14 | Hoffmann La Roche | Metodo para obtener una eritropoyetina mono-pegilada en una forma sustancialmente homogenea |
| WO2009058769A1 (en) | 2007-10-30 | 2009-05-07 | Schering Corporation | Purification of antibodies containing hydrophobic variants |
| EP2346900A1 (en) | 2008-10-29 | 2011-07-27 | Wyeth LLC | Methods for purification of single domain antigen binding molecules |
| SI2914612T1 (sl) * | 2012-10-30 | 2019-03-29 | F. Hoffmann-La Roche Ag | Čiščenje polipeptidov z uporabo dvostopenjske tangencialne ultrafiltracije |
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2010
- 2010-09-29 EP EP16188558.7A patent/EP3133083B1/en active Active
- 2010-09-29 CN CN201510004012.6A patent/CN104610447A/zh active Pending
- 2010-09-29 HU HUE10757795A patent/HUE030186T2/en unknown
- 2010-09-29 CN CN2010800444816A patent/CN102574913A/zh active Pending
- 2010-09-29 KR KR1020127008385A patent/KR101508044B1/ko active IP Right Grant
- 2010-09-29 MX MX2012003727A patent/MX342442B/es active IP Right Grant
- 2010-09-29 JP JP2012531416A patent/JP5458183B2/ja active Active
- 2010-09-29 SI SI201032002T patent/SI3133083T1/sl unknown
- 2010-09-29 EP EP10757795.9A patent/EP2483305B1/en active Active
- 2010-09-29 DK DK10757795.9T patent/DK2483305T3/en active
- 2010-09-29 LT LTEP10757795.9T patent/LT2483305T/lt unknown
- 2010-09-29 SI SI201031343A patent/SI2483305T1/sl unknown
- 2010-09-29 CA CA2773674A patent/CA2773674C/en active Active
- 2010-09-29 US US13/394,766 patent/US20120231506A1/en not_active Abandoned
- 2010-09-29 EP EP20156152.9A patent/EP3715369A1/en active Pending
- 2010-09-29 CN CN201410246761.5A patent/CN103980346A/zh active Pending
- 2010-09-29 KR KR1020147016901A patent/KR101653471B1/ko active IP Right Grant
- 2010-09-29 PL PL10757795T patent/PL2483305T3/pl unknown
- 2010-09-29 AU AU2010302662A patent/AU2010302662B2/en active Active
- 2010-09-29 PL PL16188558T patent/PL3133083T3/pl unknown
- 2010-09-29 KR KR1020167023445A patent/KR101718301B1/ko active IP Right Grant
- 2010-09-29 ES ES16188558T patent/ES2787403T3/es active Active
- 2010-09-29 BR BR112012004054-5A patent/BR112012004054B1/pt active IP Right Grant
- 2010-09-29 WO PCT/EP2010/064487 patent/WO2011039274A1/en active Application Filing
- 2010-09-29 ES ES10757795.9T patent/ES2604103T3/es active Active
- 2010-09-29 PT PT107577959T patent/PT2483305T/pt unknown
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2012
- 2012-01-19 IL IL217626A patent/IL217626A/en active IP Right Grant
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2015
- 2015-01-21 HK HK15100670.0A patent/HK1200178A1/xx unknown
- 2015-10-28 HK HK15110663.8A patent/HK1210183A1/xx unknown
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2016
- 2016-11-25 CY CY20161101229T patent/CY1118577T1/el unknown
- 2016-12-12 HR HRP20161693TT patent/HRP20161693T1/hr unknown
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2017
- 2017-02-27 US US15/444,018 patent/US20180009878A1/en not_active Abandoned
- 2017-11-14 IL IL255658A patent/IL255658A/en active IP Right Grant
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2019
- 2019-10-22 US US16/660,635 patent/US11891430B2/en active Active
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2020
- 2020-04-14 HR HRP20200588TT patent/HRP20200588T1/hr unknown
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2023
- 2023-12-20 US US18/389,809 patent/US20240132574A1/en active Pending
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