HRP20231432T1 - Pročišćavanje proteina - Google Patents
Pročišćavanje proteina Download PDFInfo
- Publication number
- HRP20231432T1 HRP20231432T1 HRP20231432TT HRP20231432T HRP20231432T1 HR P20231432 T1 HRP20231432 T1 HR P20231432T1 HR P20231432T T HRP20231432T T HR P20231432TT HR P20231432 T HRP20231432 T HR P20231432T HR P20231432 T1 HRP20231432 T1 HR P20231432T1
- Authority
- HR
- Croatia
- Prior art keywords
- chromatography
- protein
- chromatographic matrix
- interest
- mixture
- Prior art date
Links
- 238000001742 protein purification Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 16
- 102000004169 proteins and genes Human genes 0.000 claims 16
- 108090000623 proteins and genes Proteins 0.000 claims 16
- 239000000203 mixture Substances 0.000 claims 13
- 238000004587 chromatography analysis Methods 0.000 claims 11
- 239000012504 chromatography matrix Substances 0.000 claims 11
- 230000003068 static effect Effects 0.000 claims 3
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 1
- 238000001042 affinity chromatography Methods 0.000 claims 1
- 238000013019 agitation 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
- 238000001816 cooling Methods 0.000 claims 1
- 238000010790 dilution Methods 0.000 claims 1
- 239000012895 dilution Substances 0.000 claims 1
- 238000003821 enantio-separation Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 1
- 238000004255 ion exchange chromatography Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000010979 pH adjustment Methods 0.000 claims 1
- 239000002904 solvent Substances 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
-
- 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
-
- 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
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (13)
1. Postupak pročišćavanja proteina od značaja iz smjese koja obuhvaća korake
a) u ciklusu operativne kromatografije, punjenje smjese koja sadrži protein od značaja iz prve posude na kromatografsku matricu koja radi tako da se protein veže za kromatografsku matricu dok se ne dostigne 40 do 100% statičkog kapaciteta vezanja za kromatografsku matricu;
b) sakupljanje protočne smjese koji sadrži protein od značaja koji nije vezan u drugu posudu, i
c) u daljem ciklusu operativne kromatografije, ponovno punjenje protočne smjese iz druge posude na istu kromatografsku matricu koja radi tako da se protein od značaja veže za kromatografsku matricu dok se ne dostigne 40 do 100% statičkog kapaciteta vezanja za kromatografsku matricu.
2. Postupak pročišćavanja proteina od značaja iz smjese koja obuhvaća korake:
a) u ciklusu operativne kromatografije, punjenje prve zapremine smjese koja sadrži protein od značaja iz prve posude na kromatografsku matricu koja radi tako da je prekoračen dinamički kapacitet vezanja za kromatografsku matricu;
b) sakupljanje protočne smjese koji sadrži protein od značaja koji nije vezan u drugu posudu, i
c) u daljem ciklusu operativne kromatografije, ponovno punjenje protočne smjese iz druge posude i punjenje druge zapremine proteina od značaja iz prve posude na istu kromatografsku matricu, koja radi tako da je prekoračen dinamički kapacitet vezanja za kromatografsku matricu.
3. Postupak prema patentnom zahtjevu 2, pri čemu se u koraku (a) punjenje proteina od značaja zaustavlja kada se dostigne najmanje 40% maksimalnog statičkog kapaciteta vezanja.
4. Postupak prema patentnom zahtjevu 1, 2 ili 3, pri čemu je dalji ciklus operativne kromatografije ciklus kromatografije koji neposredno slijedi.
5. Postupak prema patentnom zahtjevu 1, 2, 3 ili 4, pri čemu se prikupljanje protočne smjese započinje pri unaprijed određenoj prvoj koncentraciji proteina od značaja u protočnoj smjesi i zaustavlja se na unaprijed određenoj drugoj koncentraciji proteina od značaja u protočnoj smjesi.
6. Postupak prema bilo kojem od patentnih zahtjeva 1 do 5, pri čemu se unaprijed određeni dio protočne smjese sakuplja u drugoj posudi.
7. Postupak prema bilo kojem od patentnih zahtjeva 1 do 6, pri čemu se protočna smjesa obrađuje prije ponovnog punjenja na kromatografsku matricu, obrada je izabrana između miješanja ili agitacije, razblaživanja, podešavanja koncentracije, podešavanja pH, podešavanja provodljivosti, zamjene pufera ili otapala, hlađenja ili zagrijavanja ili bilo koje njihove kombinacije.
8. Postupak prema bilo kojem od patentnih zahtjeva 1 do 7, pri čemu je kromatografija izabrana između afinitetne kromatografije, jonoizmjenjivačke kromatografije, kromatografije hidrofobne interakcije, kromatografije mješovitog režima, kiralne kromatografije ili dielektrične kromatografije.
9. Postupak prema bilo kojem od patentnih zahtjeva 1 do 8, pri čemu postupak obuhvaća tri kromatografska koraka.
10. Postupak prema patentnom zahtjevu 9, pri čemu postupak obuhvaća kromatografiju Proteina A praćenu kromatografijom izmjene kationa koja je praćena kromatografijom izmjene aniona.
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, pri čemu se jedna, dvije, tri ili sve kromatografske matrice su u koloni za kromatografiju.
12. Postupak prema bilo kojem od patentnih zahtjeva 1 do 11, pri čemu je protein od značaja antitijelo ili fragment antitijela.
13. Postupak za proizvodnju proteina od značaja obuhvaća postupak pročišćavanja proteina prema bilo kojem od patentnih zahtjeva 1 do 12.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1602938.1A GB201602938D0 (en) | 2016-02-19 | 2016-02-19 | Protein purification |
| EP20179961.6A EP3730511B1 (en) | 2016-02-19 | 2017-02-17 | Protein purification |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231432T1 true HRP20231432T1 (hr) | 2024-03-01 |
Family
ID=55752913
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201415TT HRP20201415T1 (hr) | 2016-02-19 | 2017-02-17 | Pročišćavanje proteina |
| HRP20231432TT HRP20231432T1 (hr) | 2016-02-19 | 2017-02-17 | Pročišćavanje proteina |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201415TT HRP20201415T1 (hr) | 2016-02-19 | 2017-02-17 | Pročišćavanje proteina |
Country Status (27)
| Country | Link |
|---|---|
| US (2) | US20190202859A1 (hr) |
| EP (2) | EP3416974B1 (hr) |
| JP (1) | JP6911040B2 (hr) |
| KR (1) | KR102728998B1 (hr) |
| CN (1) | CN108779143B (hr) |
| AU (1) | AU2017220675B2 (hr) |
| CA (1) | CA3014488A1 (hr) |
| CL (1) | CL2018002373A1 (hr) |
| CO (1) | CO2018009057A2 (hr) |
| CY (1) | CY1123802T1 (hr) |
| DK (2) | DK3416974T3 (hr) |
| EA (1) | EA038538B1 (hr) |
| ES (2) | ES2960723T3 (hr) |
| FI (1) | FI3730511T3 (hr) |
| GB (1) | GB201602938D0 (hr) |
| HR (2) | HRP20201415T1 (hr) |
| HU (2) | HUE064240T2 (hr) |
| IL (1) | IL261040B (hr) |
| LT (2) | LT3416974T (hr) |
| MX (1) | MX2018009829A (hr) |
| MY (1) | MY186560A (hr) |
| PL (2) | PL3730511T3 (hr) |
| PT (2) | PT3416974T (hr) |
| RU (1) | RU2018133009A (hr) |
| SG (1) | SG11201806852PA (hr) |
| SI (2) | SI3730511T1 (hr) |
| WO (1) | WO2017140881A1 (hr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW201628649A (zh) | 2014-10-09 | 2016-08-16 | 再生元醫藥公司 | 減少醫藥調配物中微可見顆粒之方法 |
| BR112019000872A2 (pt) | 2016-08-16 | 2019-04-30 | Regeneron Pharmaceuticals, Inc. | métodos para quantificar anticorpos individuais de uma mistura |
| AU2017350807B2 (en) | 2016-10-25 | 2022-07-07 | Regeneron Pharmaceuticals, Inc. | Methods and systems for chromatography data analysis |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| GB201711481D0 (en) * | 2017-07-17 | 2017-08-30 | Ucb Biopharma Sprl | Protein purification |
| IL272954B2 (en) | 2017-09-19 | 2024-06-01 | Regeneron Pharma | Methods to reduce the generation of particles and preparations created by them |
| GB201805142D0 (en) * | 2018-03-29 | 2018-05-16 | Ge Healthcare Bioprocess R&D Ab | Separation method |
| TW202448568A (zh) * | 2018-07-02 | 2024-12-16 | 美商里珍納龍藥品有限公司 | 自混合物製備多肽之系統及方法 |
| JP7063759B2 (ja) * | 2018-07-25 | 2022-05-09 | 株式会社日立プラントサービス | 精製装置 |
| CN110348089B (zh) * | 2019-06-28 | 2021-05-04 | 浙江大学 | 基于层析模型实现多柱连续流层析设计及分析的方法 |
| WO2024056626A1 (en) * | 2022-09-13 | 2024-03-21 | Sanofi Aventis Deutschland Gmbh | Continuous gradient elution chromatographic fractionation |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6055162B2 (ja) * | 1977-05-26 | 1985-12-04 | 参松工業株式会社 | カラムクロマト分離法 |
| US9433922B2 (en) * | 2007-08-14 | 2016-09-06 | Emd Millipore Corporation | Media for membrane ion exchange chromatography based on polymeric primary amines, sorption device containing that media, and chromatography scheme and purification method using the same |
| US20090149638A1 (en) * | 2007-10-03 | 2009-06-11 | Ley Arthur C | Systems and methods for purifying proteins |
| CN101318991A (zh) | 2008-07-04 | 2008-12-10 | 陈志南 | 一种采用复合层析介质纯化Fc融合蛋白的方法 |
| GB201012603D0 (en) | 2010-07-27 | 2010-09-08 | Ucb Pharma Sa | Protein purification |
| JP5879357B2 (ja) * | 2010-10-27 | 2016-03-08 | ジーイー・ヘルスケア・バイオサイエンス・アクチボラグ | ガードカラムを備えるクロマトグラフィーシステム |
| JP6116565B2 (ja) * | 2011-08-25 | 2017-04-19 | エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | 陽イオンおよび陰イオン交換クロマトグラフィー法 |
| BR112014011304B1 (pt) | 2011-11-11 | 2022-03-03 | UCB Biopharma SRL | Anticorpos de ligação com albumina e fragmentos de ligação dos mesmos, proteína de fusão de anticorpo bi-específico, polinucleotídeo, célula hospedeira, processo de produção de anticorpo ou fragamento do mesmo, formulação farmacêutica e uso |
| KR20150129033A (ko) * | 2013-03-14 | 2015-11-18 | 애브비 인코포레이티드 | 저 산성 종 조성물 및 이의 제조 및 사용 방법 |
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2016
- 2016-02-19 GB GBGB1602938.1A patent/GB201602938D0/en not_active Ceased
-
2017
- 2017-02-17 AU AU2017220675A patent/AU2017220675B2/en active Active
- 2017-02-17 HR HRP20201415TT patent/HRP20201415T1/hr unknown
- 2017-02-17 RU RU2018133009A patent/RU2018133009A/ru not_active Application Discontinuation
- 2017-02-17 CN CN201780018403.0A patent/CN108779143B/zh active Active
- 2017-02-17 PT PT177062155T patent/PT3416974T/pt unknown
- 2017-02-17 ES ES20179961T patent/ES2960723T3/es active Active
- 2017-02-17 ES ES17706215T patent/ES2822918T3/es active Active
- 2017-02-17 LT LTEP17706215.5T patent/LT3416974T/lt unknown
- 2017-02-17 PL PL20179961.6T patent/PL3730511T3/pl unknown
- 2017-02-17 SG SG11201806852PA patent/SG11201806852PA/en unknown
- 2017-02-17 SI SI201731428T patent/SI3730511T1/sl unknown
- 2017-02-17 LT LTEP20179961.6T patent/LT3730511T/lt unknown
- 2017-02-17 SI SI201730429T patent/SI3416974T1/sl unknown
- 2017-02-17 CA CA3014488A patent/CA3014488A1/en active Pending
- 2017-02-17 MY MYPI2018702843A patent/MY186560A/en unknown
- 2017-02-17 DK DK17706215.5T patent/DK3416974T3/da active
- 2017-02-17 WO PCT/EP2017/053677 patent/WO2017140881A1/en active Application Filing
- 2017-02-17 JP JP2018543619A patent/JP6911040B2/ja active Active
- 2017-02-17 EA EA201891878A patent/EA038538B1/ru unknown
- 2017-02-17 HU HUE20179961A patent/HUE064240T2/hu unknown
- 2017-02-17 DK DK20179961.6T patent/DK3730511T3/da active
- 2017-02-17 EP EP17706215.5A patent/EP3416974B1/en active Active
- 2017-02-17 KR KR1020187027129A patent/KR102728998B1/ko active Active
- 2017-02-17 HR HRP20231432TT patent/HRP20231432T1/hr unknown
- 2017-02-17 HU HUE17706215A patent/HUE050774T2/hu unknown
- 2017-02-17 MX MX2018009829A patent/MX2018009829A/es unknown
- 2017-02-17 EP EP20179961.6A patent/EP3730511B1/en active Active
- 2017-02-17 US US15/999,655 patent/US20190202859A1/en not_active Abandoned
- 2017-02-17 FI FIEP20179961.6T patent/FI3730511T3/fi active
- 2017-02-17 PL PL17706215T patent/PL3416974T3/pl unknown
- 2017-02-17 PT PT201799616T patent/PT3730511T/pt unknown
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2018
- 2018-08-07 IL IL261040A patent/IL261040B/en unknown
- 2018-08-17 CL CL2018002373A patent/CL2018002373A1/es unknown
- 2018-08-28 CO CONC2018/0009057A patent/CO2018009057A2/es unknown
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2020
- 2020-10-22 CY CY20201101003T patent/CY1123802T1/el unknown
-
2021
- 2021-05-24 US US17/327,865 patent/US11905310B2/en active Active
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