HRP20171095T4 - Postupci pročišćavanja polipeptida - Google Patents
Postupci pročišćavanja polipeptida Download PDFInfo
- Publication number
- HRP20171095T4 HRP20171095T4 HRP20171095TT HRP20171095T HRP20171095T4 HR P20171095 T4 HRP20171095 T4 HR P20171095T4 HR P20171095T T HRP20171095T T HR P20171095TT HR P20171095 T HRP20171095 T HR P20171095T HR P20171095 T4 HRP20171095 T4 HR P20171095T4
- Authority
- HR
- Croatia
- Prior art keywords
- buffer
- antibody
- cation exchange
- exchange material
- mixed sample
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 27
- 229920001184 polypeptide Polymers 0.000 title claims 4
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 4
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 4
- 239000000463 material Substances 0.000 claims 12
- 238000005341 cation exchange Methods 0.000 claims 9
- 239000006167 equilibration buffer Substances 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 239000000523 sample Substances 0.000 claims 6
- 239000000872 buffer Substances 0.000 claims 5
- 239000011534 wash buffer Substances 0.000 claims 5
- 239000012634 fragment Substances 0.000 claims 4
- 150000001768 cations Chemical class 0.000 claims 3
- 239000000356 contaminant Substances 0.000 claims 3
- 102000004169 proteins and genes Human genes 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- -1 sulfopropyl Chemical group 0.000 claims 3
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 125000000524 functional group Chemical group 0.000 claims 2
- 241000699802 Cricetulus griseus Species 0.000 claims 1
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 claims 1
- 229930182566 Gentamicin Natural products 0.000 claims 1
- 102000001706 Immunoglobulin Fab Fragments Human genes 0.000 claims 1
- 108010054477 Immunoglobulin Fab Fragments Proteins 0.000 claims 1
- 238000005349 anion exchange Methods 0.000 claims 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 1
- 125000002843 carboxylic acid group Chemical group 0.000 claims 1
- 239000012534 cell culture medium component Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229960002518 gentamicin Drugs 0.000 claims 1
- 230000002209 hydrophobic effect Effects 0.000 claims 1
- 230000003993 interaction Effects 0.000 claims 1
- 239000012160 loading buffer Substances 0.000 claims 1
- 210000001672 ovary Anatomy 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 238000011084 recovery Methods 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 125000000542 sulfonic acid group Chemical group 0.000 claims 1
- 230000003612 virological effect Effects 0.000 claims 1
Classifications
-
- 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
- C07K1/18—Ion-exchange chromatography
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
- B01D15/3847—Multimodal interactions
-
- 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
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode 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
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
- G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Analytical Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (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)
Claims (23)
1. Postupak pročišćavanja protutijela, koje je monoklonsko protutijelo, iz sastava koji sadrži protutijelo i najmanje jedan kontaminant, naznačen time da metoda sadržava ili (i) ili (ii):
(i) uzastopne korake (a) unosa sastava na materijal kationskog izmjenjivača pri gustoći unosa većoj od otprilike 150 g/l materijala kationskog izmjenjivača; i (b) unosa sastava oporavljenog s materijala kationskog izmjenjivača na materijal mješovitog uzorka; ili
(ii) uzastopne korake (a) unosa sastava na materijal mješovitog uzorka; i (b) unos sastava oporavljenog s materijala mješovitog uzorka na materijal kationskog izmjenjivača pri gustoći unosa većoj od otprilike 150 g/l materijala kationskog izmjenjivača,
pri čemu se materijal kationskog izmjenjivača sastoji od čestica smole.
2. Postupak prema patentnom zahtjevu 1, naznačen time što protutijelo ima pi između otprilike 6 i otprilike 10.
3. Postupak prema patentnom zahtjevu 2, naznačen time što protutijelo ima pi između otprilike 7 i otprilike 9.
4. Postupak prema patentnom zahtjevu 1, naznačen time što je monoklonsko protutijelo kimerno protutijelo, humanizirano protutijelo ili humano protutijelo.
5. Postupak prema patentnom zahtjevu 1, naznačen time što je monoklonsko protutijelo monoklonsko protutijelo IgG.
6. Postupak prema patentnom zahtjevu 1, naznačen time što je protutijelo vezni fragment antigena.
7. Postupak prema patentnom zahtjevu 6, naznačen time što je vezni fragment antigena odabran iz skupine koja se sastoji od fragmenta Fab, fragmenta Fab`, fragmenta F(ab`)2, scFv, Fv i dijatijela.
8. Postupak prema jednom od patentnih zahtjeva 1 do 7, naznačen time što je barem jedan kontaminant jedan ili više proteina jajnika ženke kineskog hrčka (CHOP), isprani protein A, DNK, agregirani protein, komponenta medija stanične kulture, gentamicin i virusni kontaminant.
9. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što su uzastopni koraci u (i) i/ili (ii) neprekidni.
10. Postupak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što je metoda (i).
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što je metoda (ii).
12. Postupak prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time što je gustoća unosa između otprilike 150 g/l i otprilike 2000 g/l materijala kationskog izmjenjivača.
13. Postupak prema patentnom zahtjevu 12, naznačen time što je gustoća unosa između otprilike 500 g/l i otprilike 1000 g/l materijala kationskog izmjenjivača.
14. Postupak prema bilo kojem od patentnih zahtjeva 1 do 13, naznačen time što se materijal kationskog izmjenjivača sastoji od funkcionalne skupine karboksilne kiseline ili funkcionalne skupine sulfonske kiseline.
15. Postupak prema patentnom zahtjevu 14, naznačen time što je funkcionalna skupina sulfopropil, sulfoetil, sulfoizobutil ili karboksil.
16. Postupak prema bilo kojem od patentnih zahtjeva 1 do 15, naznačen time što se mješoviti materijal sastoji od funkcionalnih skupina sposobnih za izmjenu aniona i hidrofobne interakcije.
17. Postupak prema bilo kojem od patentnih zahtjeva 1 do 16, naznačen time što obuhvaća uporabu pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos s materijalom kationskog izmjenjivača i/ili materijalom mješovitog uzorka te je provodnost pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos između otprilike 2 mS/cm do otprilike 25 mS/cm.
18. Postupak prema patentnom zahtjevu 17, naznačen time što je provodnost pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos između otprilike 3 mS/cm i 8 mS/cm.
19. Postupak prema bilo kojem od patentnih zahtjeva 1 do 18, naznačena time što se sastoji od uporabe pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos s materijalom kationskog izmjenjivača i/ili materijalom mješovitog uzorka te je pH pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos između otprilike 4,5 mS/cm i otprilike 6,5 mS/cm.
20. Postupak prema bilo kojem od patentnih zahtjeva 17 do 19, naznačen time što su pufer za uravnoteživanje, pufer za pranje i/ili pufer za unos s kationskim izmjenjivačem i/ili materijalom mješovitog uzorka jednaki.
21. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća podvrgavanje sastava koji uključuje polipeptide jednom ili više koraka pročišćavanja bilo prije ili nakon koraka (a) i (b).
22. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da nadalje obuhvaća oporavak pročišćenog polipeptida.
23. Postupak prema patentnom zahtjevu 22, naznačen time, da se nadalje obuhvaća kombiniranje pročišćenog polipeptida s farmaceutski prihvatljivim nosačem.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US34814310P | 2010-05-25 | 2010-05-25 | |
| EP11787363.8A EP2575847B2 (en) | 2010-05-25 | 2011-05-25 | Methods of purifying polypeptides |
| PCT/US2011/037977 WO2011150110A1 (en) | 2010-05-25 | 2011-05-25 | Methods of purifying polypeptides |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20171095T1 HRP20171095T1 (hr) | 2017-10-06 |
| HRP20171095T4 true HRP20171095T4 (hr) | 2022-07-22 |
Family
ID=45004368
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171095TT HRP20171095T4 (hr) | 2010-05-25 | 2011-05-25 | Postupci pročišćavanja polipeptida |
Country Status (21)
| Country | Link |
|---|---|
| US (4) | US20130079272A1 (hr) |
| EP (2) | EP2575847B2 (hr) |
| JP (3) | JP5934190B2 (hr) |
| KR (1) | KR101976853B1 (hr) |
| CN (2) | CN107365346A (hr) |
| AU (1) | AU2011258254B2 (hr) |
| BR (1) | BR112012029904A2 (hr) |
| CA (2) | CA2799915C (hr) |
| ES (1) | ES2637613T5 (hr) |
| HK (1) | HK1246328A1 (hr) |
| HR (1) | HRP20171095T4 (hr) |
| IL (2) | IL223029A0 (hr) |
| MX (2) | MX344248B (hr) |
| MY (1) | MY161534A (hr) |
| NZ (1) | NZ603648A (hr) |
| PL (1) | PL2575847T5 (hr) |
| RU (1) | RU2594163C2 (hr) |
| SG (2) | SG10201710439UA (hr) |
| SI (1) | SI2575847T2 (hr) |
| WO (1) | WO2011150110A1 (hr) |
| ZA (1) | ZA201208673B (hr) |
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| WO2013088259A2 (en) * | 2011-10-19 | 2013-06-20 | Novimmune S.A. | Methods of purifying antibodies |
| AU2012355356B2 (en) | 2011-12-22 | 2017-10-12 | Genentech, Inc. | Ion exchange membrane chromatography |
| CN102911250B (zh) * | 2012-09-29 | 2014-04-16 | 浙江海正药业股份有限公司 | 酸性重组蛋白药物的纯化方法 |
| CN103880947B (zh) * | 2012-12-21 | 2016-01-13 | 武汉禾元生物科技股份有限公司 | 一种分离纯化高纯度重组人血清白蛋白的层析方法 |
| WO2014118685A2 (en) * | 2013-01-29 | 2014-08-07 | Dr. Reddy's Laboratories Limited | Method of altering the acidic variant content of antibody |
| EP2971087B1 (en) | 2013-03-14 | 2017-11-01 | Qiagen Sciences, LLC | Assessing dna quality using real-time pcr and ct values |
| CN104236983A (zh) * | 2013-06-14 | 2014-12-24 | 中国科学院大连化学物理研究所 | 溶液样品中含长烷基链的离子液体的去除方法 |
| KR20160050062A (ko) | 2013-09-05 | 2016-05-10 | 제넨테크, 인크. | 크로마토그래피 재사용 방법 |
| CA2921999C (en) | 2013-09-13 | 2023-03-21 | Genentech, Inc. | Methods and compositions comprising an anti-il13 antibody and residual hamster phospholipase b-like 2 |
| WO2015038884A2 (en) | 2013-09-13 | 2015-03-19 | Genentech, Inc. | Compositions and methods for detecting and quantifying host cell protein in cell lines and recombinant polypeptide products |
| AU2014337263B2 (en) | 2013-10-16 | 2019-12-12 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| US8859252B1 (en) | 2014-01-02 | 2014-10-14 | Aerial Biopharma, Llc | Prostatic acid phosphatase, compositions comprising the same, and methods for producing and/or purifying the same |
| US10214747B2 (en) | 2014-01-09 | 2019-02-26 | Kentucky Bioprocessing, Inc. | Method of purifying monoclonal antibodies |
| KR101921552B1 (ko) | 2014-03-10 | 2018-11-23 | 리히터 게데온 닐트. | 사전 세정 단계를 이용하는 면역글로불린 정제 |
| US9920107B2 (en) | 2014-05-23 | 2018-03-20 | Instituto Massone S.A. | Process for obtaining HMG-UP (human menopausal gonadotropin with ultra-purity grade) and a composition free of contaminants |
| WO2015198320A1 (en) * | 2014-06-24 | 2015-12-30 | Insight Biopharmaceuticals Ltd. | Methods of purifying antibodies |
| GB201411802D0 (en) | 2014-07-02 | 2014-08-13 | Univ Bradford | Effervescent compositions |
| WO2016118707A1 (en) * | 2015-01-21 | 2016-07-28 | Oncobiologics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
| US11285210B2 (en) | 2016-02-03 | 2022-03-29 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| JP2019521986A (ja) | 2016-06-17 | 2019-08-08 | ジェネンテック， インコーポレイテッド | 多重特異性抗体の精製 |
| SG11201901228QA (en) | 2016-08-15 | 2019-03-28 | Genentech Inc | Chromatography method for quantifying a non-ionic surfactant in a composition comprising the non-ionic surfactant and a polypeptide |
| JP6564539B1 (ja) | 2018-09-14 | 2019-08-21 | 長瀬産業株式会社 | スルホン酸化合物によるペプチド精製方法 |
| JP7458404B2 (ja) | 2018-12-20 | 2024-03-29 | アーマジェン・インコーポレイテッド | イズロン酸－２－スルファターゼ免疫グロブリン融合タンパク質の精製 |
| CN109765307B (zh) * | 2018-12-24 | 2021-06-29 | 山东省科学院海洋仪器仪表研究所 | 一种水体中六氯环己烷的测量方法 |
| CN111366547A (zh) * | 2018-12-26 | 2020-07-03 | 贵州中烟工业有限责任公司 | 一种用连续流动法测定烟草或烟草制品中α-氨基氮的检测方法 |
| EP3916001A4 (en) | 2019-01-23 | 2022-10-19 | Daiichi Sankyo Company, Limited | ONE-STEP PROCEDURE FOR PURIFICATION OF ANTIBODIES USING ACTIVATED CARBON MATERIAL |
| TW202112799A (zh) * | 2019-06-05 | 2021-04-01 | 美商建南德克公司 | 過載層析管柱之再生方法 |
| US20220396598A1 (en) * | 2019-10-14 | 2022-12-15 | Pierce Biotechnology, Inc. | Peptide purification formulations and methods |
| US20230251269A1 (en) * | 2020-07-15 | 2023-08-10 | The Johns Hopkins University | Comprehensive analysis of anti-allergen antibodies using phage display |
| CN112852876B (zh) * | 2021-03-04 | 2022-11-29 | 西南大学 | 一种表达人表皮生长因子的家蚕丝腺重组表达载体及其制备方法和应用 |
| JP2024514306A (ja) | 2021-03-31 | 2024-04-01 | エフ． ホフマン－ラ ロシュ アーゲー | 混合モードクロマトグラフィーによる抗体の精製 |
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