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
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 (3) | US20120231506A1 (hr) |
| EP (3) | EP3133083B1 (hr) |
| JP (1) | JP5458183B2 (hr) |
| KR (3) | KR101508044B1 (hr) |
| CN (3) | CN103980346A (hr) |
| AU (1) | AU2010302662B2 (hr) |
| BR (1) | BR112012004054B1 (hr) |
| CA (1) | CA2773674C (hr) |
| CY (1) | CY1118577T1 (hr) |
| DK (1) | DK2483305T3 (hr) |
| ES (2) | ES2604103T3 (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) | SI2483305T1 (hr) |
| WO (1) | WO2011039274A1 (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019183334A1 (en) | 2018-03-21 | 2019-09-26 | 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 |
| WO1989006692A1 (en) | 1988-01-12 | 1989-07-27 | Genentech, Inc. | Method of treating tumor cells by inhibiting growth factor receptor function |
| DE3818860A1 (de) | 1988-06-03 | 1989-12-07 | Seitz Filter Werke | Filterelement |
| DE122004000008I1 (de) | 1991-06-14 | 2005-06-09 | Genentech Inc | Humanisierter Heregulin Antikörper. |
| DE4204444C1 (hr) | 1992-02-14 | 1993-05-19 | Krankenhausentsorgungs Gmbh, 1000 Berlin, De | |
| WO1997004801A1 (en) | 1995-07-27 | 1997-02-13 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| DE69739673D1 (de) | 1996-11-27 | 2009-12-31 | Genentech Inc | Affinitätsreinigung von Polypeptid-Proteinen auf einer Protein A Matrix |
| IL139035A0 (en) | 1998-05-06 | 2001-11-25 | Genentech Inc | Protein purification by ion exchange chromatography |
| US6984494B2 (en) * | 2000-08-15 | 2006-01-10 | Genentech, Inc. | Analytical method |
| JP4460302B2 (ja) | 2002-02-05 | 2010-05-12 | ジェネンテック インコーポレイテッド | タンパク質精製法 |
| CN1671741A (zh) * | 2002-06-21 | 2005-09-21 | 拜奥根Idec公司 | 浓缩抗体的缓冲剂制剂及其使用方法 |
| AU2003271095B2 (en) * | 2002-10-04 | 2009-06-11 | Kirin Beer Kabushiki Kaisha | Human artificial chromosome (HAC) vector |
| WO2004087761A1 (ja) | 2003-03-31 | 2004-10-14 | Kirin Beer Kabushiki Kaisha | 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 |
| EP1773383B1 (en) * | 2004-05-27 | 2012-09-12 | Jon A. Weidanz | Antibodies as t cell receptor mimics, methods of production and uses thereof |
| EP1786273B1 (en) * | 2004-08-20 | 2018-11-14 | ProMetic BioSciences Ltd. | Sequential protein isolation and purification schemes by affinity chromatography |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| CA2586130A1 (en) * | 2004-11-22 | 2006-05-26 | Oxygenix Co., Ltd. | Reagent containing oxygen isotope-labeled hemoglobin for examining vital tissue and method of producing the same |
| TWI306862B (en) | 2005-01-03 | 2009-03-01 | Hoffmann La Roche | Antibodies against il-13 receptor alpha 1 and uses thereof |
| WO2006096488A2 (en) * | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | Composition comprising human igg2 antibody and chelating agent |
| JPWO2007018316A1 (ja) | 2005-08-09 | 2009-02-19 | 武田薬品工業株式会社 | 癌の予防・治療剤 |
| US9109015B2 (en) * | 2006-11-01 | 2015-08-18 | Biogen Ma Inc | Method of isolating biomacromolecules using low pH and divalent cations |
| AR067536A1 (es) | 2007-07-17 | 2009-10-14 | Hoffmann La Roche | Metodo para obtener una eritropoyetina mono-pegilada en una forma sustancialmente homogenea |
| EP2170949B1 (en) * | 2007-07-17 | 2012-12-26 | F. Hoffmann - La Roche AG | Variable tangential flow filtration |
| WO2009058769A1 (en) | 2007-10-30 | 2009-05-07 | Schering Corporation | Purification of antibodies containing hydrophobic variants |
| MX2011004558A (es) | 2008-10-29 | 2011-06-01 | Wyeth Llc | Procedimientos para la purificacion de moleculas de union a antigeno de un unico dominio. |
| SI2914612T1 (sl) * | 2012-10-30 | 2019-03-29 | F. Hoffmann-La Roche Ag | Čiščenje polipeptidov z uporabo dvostopenjske tangencialne ultrafiltracije |
-
2010
- 2010-09-29 CN CN201410246761.5A patent/CN103980346A/zh active Pending
- 2010-09-29 BR BR112012004054-5A patent/BR112012004054B1/pt active IP Right Grant
- 2010-09-29 ES ES10757795.9T patent/ES2604103T3/es active Active
- 2010-09-29 MX MX2012003727A patent/MX342442B/es active IP Right Grant
- 2010-09-29 WO PCT/EP2010/064487 patent/WO2011039274A1/en active Application Filing
- 2010-09-29 HU HUE10757795A patent/HUE030186T2/en unknown
- 2010-09-29 AU AU2010302662A patent/AU2010302662B2/en active Active
- 2010-09-29 PL PL10757795T patent/PL2483305T3/pl unknown
- 2010-09-29 CA CA2773674A patent/CA2773674C/en active Active
- 2010-09-29 KR KR1020127008385A patent/KR101508044B1/ko active IP Right Grant
- 2010-09-29 PT PT107577959T patent/PT2483305T/pt unknown
- 2010-09-29 CN CN2010800444816A patent/CN102574913A/zh active Pending
- 2010-09-29 KR KR1020167023445A patent/KR101718301B1/ko active IP Right Grant
- 2010-09-29 US US13/394,766 patent/US20120231506A1/en not_active Abandoned
- 2010-09-29 LT LTEP10757795.9T patent/LT2483305T/lt unknown
- 2010-09-29 EP EP16188558.7A patent/EP3133083B1/en active Active
- 2010-09-29 DK DK10757795.9T patent/DK2483305T3/en active
- 2010-09-29 SI SI201031343A patent/SI2483305T1/sl unknown
- 2010-09-29 SI SI201032002T patent/SI3133083T1/sl unknown
- 2010-09-29 EP EP10757795.9A patent/EP2483305B1/en active Active
- 2010-09-29 EP EP20156152.9A patent/EP3715369A1/en active Pending
- 2010-09-29 PL PL16188558T patent/PL3133083T3/pl unknown
- 2010-09-29 ES ES16188558T patent/ES2787403T3/es active Active
- 2010-09-29 CN CN201510004012.6A patent/CN104610447A/zh active Pending
- 2010-09-29 JP JP2012531416A patent/JP5458183B2/ja active Active
- 2010-09-29 KR KR1020147016901A patent/KR101653471B1/ko active IP Right Grant
-
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
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