HRP20200588T1 - Završno filtriranje u više koraka - Google Patents
Završno filtriranje u više koraka Download PDFInfo
- Publication number
- HRP20200588T1 HRP20200588T1 HRP20200588TT HRP20200588T HRP20200588T1 HR P20200588 T1 HRP20200588 T1 HR P20200588T1 HR P20200588T T HRP20200588T T HR P20200588TT HR P20200588 T HRP20200588 T HR P20200588T HR P20200588 T1 HRP20200588 T1 HR P20200588T1
- Authority
- HR
- Croatia
- Prior art keywords
- pore size
- her2 antibody
- filter
- her2
- solution
- Prior art date
Links
- 238000001914 filtration Methods 0.000 title 1
- 239000011148 porous material Substances 0.000 claims 4
- 238000000034 method Methods 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000011045 prefiltration Methods 0.000 claims 2
- 238000001042 affinity chromatography Methods 0.000 claims 1
- 238000005571 anion exchange chromatography Methods 0.000 claims 1
- 238000005277 cation exchange chromatography Methods 0.000 claims 1
- 238000011210 chromatographic step 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
- 239000001963 growth medium Substances 0.000 claims 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 238000000746 purification Methods 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 (2)
1. Postupak za proizvodnju anti-HER2 protutijela, naznačen time, da sadrži sljedeće korake:
a) kultiviranje stanice koja sadrži nukleinsku kiselinu koja kodira anti-HER2 protutijelo,
b) dobivanje anti-HER2 protutijela iz stanice ili kultivacijskog medija,
c) pročišćavanje anti-HER2 protutijela s jednim ili više koraka kromatografije i dobivanje otopine anti-HER2 protutijela,
d) dodavanje šećera i deterdženta u otopinu,
e) koncentriranje otopine anti-HER2 protutijela do koncentracije od 125 g/l ili više, postupkom odabranim od dijafiltracije ili filtracije tangencijalnog protoka, i
f) nanošenje otopine anti-HER2 protutijela 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 filter s veličinom pora od 0,22 µm, s tlakom od 0,75 bara ili manje, i na taj način proizvodnja anti-HER2 protutijela.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time, da je korak pročišćavanja s afinitetnom kromatografijom proteina A i barem jedan korak odabran između kromatografije kationskom izmjenom, kromatografije anionskom izmjenom i hidrofobne interakcijske kromatografije.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP09012460 | 2009-10-01 | ||
| EP16188558.7A EP3133083B1 (en) | 2009-10-01 | 2010-09-29 | Multistep final filtration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200588T1 true HRP20200588T1 (hr) | 2020-07-10 |
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 Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161693TT HRP20161693T1 (hr) | 2009-10-01 | 2016-12-12 | Završno filtriranje imunoglobulina 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 |
|---|---|---|---|---|
| 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 |
-
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
-
2012
- 2012-01-19 IL IL217626A patent/IL217626A/en active IP Right Grant
-
2015
- 2015-01-21 HK HK15100670.0A patent/HK1200178A1/xx unknown
- 2015-10-28 HK HK15110663.8A patent/HK1210183A1/xx unknown
-
2016
- 2016-11-25 CY CY20161101229T patent/CY1118577T1/el unknown
- 2016-12-12 HR HRP20161693TT patent/HRP20161693T1/hr unknown
-
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
-
2019
- 2019-10-22 US US16/660,635 patent/US11891430B2/en active Active
-
2020
- 2020-04-14 HR HRP20200588TT patent/HRP20200588T1/hr unknown
-
2023
- 2023-12-20 US US18/389,809 patent/US20240132574A1/en active Pending
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