HRP20171095T1 - Postupci pročišćavanja polipeptida - Google Patents
Postupci pročišćavanja polipeptida Download PDFInfo
- Publication number
- HRP20171095T1 HRP20171095T1 HRP20171095TT HRP20171095T HRP20171095T1 HR P20171095 T1 HRP20171095 T1 HR P20171095T1 HR P20171095T T HRP20171095T T HR P20171095TT HR P20171095 T HRP20171095 T HR P20171095T HR P20171095 T1 HRP20171095 T1 HR P20171095T1
- Authority
- HR
- Croatia
- Prior art keywords
- buffer
- antibody
- cation exchange
- exchange material
- composition
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 30
- 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
- 239000000872 buffer Substances 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 7
- 239000000523 sample Substances 0.000 claims 6
- 239000011534 wash buffer Substances 0.000 claims 6
- 239000006167 equilibration 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
- 102000017727 Immunoglobulin Variable Region Human genes 0.000 claims 1
- 108010067060 Immunoglobulin Variable Region 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
- 239000006143 cell culture medium Substances 0.000 claims 1
- 239000000539 dimer Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000011067 equilibration Methods 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
- 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
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- 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 (24)
1. Postupak pročišćavanja protutijela ili imunoadhezina od sastava koji se sastoji od protutijela ili imunoadhezina i najmanje jednog kontaminanta, naznačen time, da postupak obuhvaća ili (i) ili (ii):
(i) uzastopne korake (a) unosa sastava na materijal kationskog izmjenjivača pri gustoći unosa većoj od oko 150 g/L materijala kationskog izmjenjivača; i (b) unosa sastava oporavljenog od materijala kationskog izmjenjivača na materijal mješovitog uzorka; ili
(ii) uzastopne korake (a) unosa sastava na materijal mješovitog uzorka; i (b) unosa sastava oporavljenog od materijala mješovitog uzorka na materijal kationskog izmjenjivača pri gustoći unosa većoj od oko 150 g/L materijala kationskog izmjenjivača,
pri čemu se materijal kationskog izmjenjivača sastoji od čestica smole.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da protutijelo ili imunoadhezin ima pI od oko 6 do oko 10.
3. Postupak prema patentnom zahtjevu 2, naznačen time, da protutijelo ili imunoadhezin ima pI od oko 7 do oko 9.
4. Postupak prema patentnom zahtjevu 1, naznačen time, da protutijelo je monoklonsko protutijelo.
5. Postupak prema patentnom zahtjevu 4, naznačen time, da monoklonsko protutijelo je kimerno protutijelo, humanizirano protutijelo ili ljudsko protutijelo.
6. Postupak prema patentnom zahtjevu 4, naznačen time, da monoklonsko protutijelo je monoklonsko protutijelo IgG.
7. Postupak prema patentnom zahtjevu 1, naznačen time, da protutijelo je fragment koji veže antigen.
8. Postupak prema patentnom zahtjevu 7, naznačen time, da je fragment za vezanje antigena odabran iz skupine koja se sastoji od fragmenta Fab, fragmenta Fab', fragmenta F(ab')2, scFv, Fv i dimernog fragmenta protutijela scFv ili Fv.
9. Postupak prema jednom od patentnih zahtjeva 1 do 8, naznačen time, da je barem jedan kontaminant bilo koji od jednog ili više proteina jajnika ženke kineskog hrčka (CHOP), isprani protein A, DNK, agregirani protein, komponenta medija stanične kulture, gentamicin i virusni kontaminant.
10. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da su uzastopni koraci u (i) i/ili u (ii) neprekidni.
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da se radi o postupku (i).
12. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da se radi o postupku (ii).
13. Postupak prema bilo kojem od patentnih zahtjeva 1 do 12, naznačen time, da je gustoća unosa od oko 150 g/L do oko 2000 g/L materijala kationskog izmjenjivača.
14. Postupak prema patentnom zahtjevu 13, naznačen time, da je gustoća unosa od oko 500 g/L do oko 1000 g/L materijala kationskog izmjenjivača.
15. Postupak prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time, da se materijal kationskog izmjenjivača sastoji od funkcionalne skupine karboksilne kiseline ili funkcionalne skupine sulfonske kiseline.
16. Postupak prema patentnom zahtjevu 15, naznačen time, da funkcionalna skupina je sulfopropil, sulfoetil, sulfoizobutil ili karboksil.
17. Postupak prema bilo kojem od patentnih zahtjeva 1 do 16, naznačen time, da se materijal mješovitog uzorka sastoji od funkcionalnih skupina sposobnih za izmjenu aniona i za hidrofobne interakcije.
18. Postupak prema bilo kojem od patentnih zahtjeva 1 do 17, naznačen time, da postupak obuhvaća uporabu pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos s materijalom kationskog izmjenjivača i/ili materijalom mješovitog uzorka, te vodljivost pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos, iznosi od oko 2 mS/cm do oko 25 mS/cm.
19. Postupak prema patentnom zahtjevu 18, naznačen time, da vodljivost pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos, iznosi od oko 3 mS/cm do oko 8 mS/cm.
20. Postupak prema bilo kojem od patentnih zahtjeva 1 do 19, naznačen time, da postupak obuhvaća uporabu pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos s materijalom kationskog izmjenjivača i/ili materijalom mješovitog uzorka, te pH-vrijednost pufera za uravnoteživanje, pufera za pranje i/ili pufera za unos, iznosi od oko 4,5 do oko 6,5.
21. Postupak prema bilo kojem od patentnih zahtjeva 18 do 20, naznačen time, da su pufer za uravnoteživanje, pufer za pranje i/ili pufer za unos s kationskim izmjenjivačem i/ili materijalom mješovitog uzorka, jednaki.
22. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća podvrgavanje sastava koji uključuje polipeptide, jednom ili većem broju dodatnih koraka pročišćavanja bilo prije ili nakon koraka (a) i (b).
23. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da nadalje obuhvaća obnavljanje pročišćenog polipeptida.
24. Postupak prema zahtjevu 23, naznačen time, da nadalje obuhvaća sastavljanje kombinacije pročišćenog polipeptida s farmaceutski prihvatljivim nosačem.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US34814310P | 2010-05-25 | 2010-05-25 | |
| PCT/US2011/037977 WO2011150110A1 (en) | 2010-05-25 | 2011-05-25 | Methods of purifying polypeptides |
| EP11787363.8A EP2575847B2 (en) | 2010-05-25 | 2011-05-25 | Methods of purifying polypeptides |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20171095T1 true HRP20171095T1 (hr) | 2017-10-06 |
| HRP20171095T4 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) | EP3299380A1 (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) | SG185737A1 (hr) |
| SI (1) | SI2575847T2 (hr) |
| WO (1) | WO2011150110A1 (hr) |
| ZA (1) | ZA201208673B (hr) |
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|---|---|---|---|---|
| PT2768857T (pt) * | 2011-10-19 | 2020-01-27 | Novimmune Sa | Métodos para purificar anticorpos |
| KR20200008022A (ko) | 2011-12-22 | 2020-01-22 | 제넨테크, 인크. | 이온 교환 막 크로마토그래피 |
| 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 |
| US20150093800A1 (en) | 2013-09-05 | 2015-04-02 | Genentech, Inc. | Method for chromatography reuse |
| NZ756750A (en) | 2013-09-13 | 2022-05-27 | Genentech Inc | Methods and compositions comprising purified recombinant polypeptides |
| PL3044323T3 (pl) | 2013-09-13 | 2022-06-27 | F.Hoffmann-La Roche Ag | Sposoby wykrywania i ilościowego oznaczania białka komórki gospodarza w liniach komórkowych |
| CN106170298B (zh) | 2013-10-16 | 2024-01-09 | 前瞻疗法公司 | 用于提高抗体稳定性的缓冲液制剂 |
| 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 |
| CA2971151C (en) * | 2014-01-09 | 2020-10-27 | Kentucky Bioprocessing, Inc. | Method of purifying monoclonal antibodies |
| SI3116891T1 (sl) | 2014-03-10 | 2020-07-31 | Richter Gedeon Nyrt. | Čiščenje imunoglobulina z uporabo predčistilnih stopenj |
| WO2015177751A1 (en) * | 2014-05-23 | 2015-11-26 | Instituto Massone S.A. | A process for obtaining hmg-up (human menopausal gonadotropin with ultra-purity grade) and a composition free of contaminants |
| US20170183376A1 (en) * | 2014-06-24 | 2017-06-29 | 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 |
| CN109563124A (zh) | 2016-06-17 | 2019-04-02 | 豪夫迈·罗氏有限公司 | 多特异性抗体的纯化 |
| JP7286536B2 (ja) | 2016-08-15 | 2023-06-05 | ジェネンテック， インコーポレイテッド | 非イオン性サーファクタント及びポリペプチドを含む組成物中の非イオン性サーファクタントを定量するためのクロマトグラフィー法 |
| 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 |
| WO2020132452A1 (en) | 2018-12-20 | 2020-06-25 | Shire Human Genetic Therapies, Inc. | Purification of iduronate-2-sulfatase immunoglobulin fusion protein |
| 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 |
| KR20210118815A (ko) | 2019-01-23 | 2021-10-01 | 다이이찌 산쿄 가부시키가이샤 | 활성탄 재료를 사용하는 공정을 포함하는 항체 정제 방법 |
| AR119264A1 (es) * | 2019-06-05 | 2021-12-09 | Genentech Inc | Método para reutilización de cromatografía |
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