HRP20210830T1 - Kontinuirani proces smanjenja heterogenosti terapijskog proteina - Google Patents
Kontinuirani proces smanjenja heterogenosti terapijskog proteina Download PDFInfo
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- HRP20210830T1 HRP20210830T1 HRP20210830TT HRP20210830T HRP20210830T1 HR P20210830 T1 HRP20210830 T1 HR P20210830T1 HR P20210830T T HRP20210830T T HR P20210830TT HR P20210830 T HRP20210830 T HR P20210830T HR P20210830 T1 HRP20210830 T1 HR P20210830T1
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- therapeutic protein
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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
- C07K1/12—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by hydrolysis, i.e. solvolysis in general
-
- 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
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Enzymes And Modification Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (13)
1. Kontinuirani postupak za smanjenje heterogenosti terapijskog proteina, postupak koji obuhvaća smanjenje jedne ili više osnovnih izoforma terapijskog proteina u jednom višestrukom kromatografskom sustavu, pri čemu pojedinačni višestruki kromatografski sustav koji sadrži najmanje dvije ili više međusobno povezanih ili prebacivanje kromatografskih stupaca i/ili kromatografskih membrana, pri čemu svaki izvodi različite operativne jedinice, u kojem pojedinačni višestruki kromatografski sustav sadrži stupac koji sadrži karboksipeptidazu B imobiliziranu na sefarozi.
2. Kontinuirani postupak za smanjenje heterogenosti terapijskog proteina, koji obuhvaća korake:
(a) pružanje višestrukog kromatografskog sustava koji sadrži prvi stupac, drugi stupac, treći stupac i četvrti stupac;
(b) dovođenje žetve stanične kulture koja sadrži terapijski protein u prvi stupac, čime se smanjuje heterogenost terapijskog proteina; pri čemu prvi stupac sadrži karboksipeptidazu B imobiliziranu na sefarozi,
(c) dovođenje protoka iz prvog stupca u drugi stupac, čime se hvata terapijski protein u protoku prvog stupca;
(d) dovođenje eluata koji sadrži terapijski protein iz drugog stupca u treći stupac radi pročišćavanja terapijskog proteina; i
(e) dovođenje protoka koji sadrži terapijski protein iz trećeg stupca u četvrti stupac radi poliranja terapijskog proteina.
3. Postupak prema zahtjevu 2, nadalje obuhvaća prikupljanje eluata koji sadrži terapijski protein iz drugog stupca i držanje eluata koji sadrži terapijski protein na niskom pH za virusnu inaktivaciju.
4. Postupak prema zahtjevu 2, nadalje obuhvaća podvrgavanje eluata koji sadrži terapijski protein iz drugog stupca podešavanju pH i vodljivosti prije dodavanja u treći stupac.
5. Postupak prema zahtjevu 2, nadalje obuhvaća podvrgavanje protoka koji sadrži terapijski protein iz trećeg stupca podešavanju pH i vodljivosti prije dodavanja u četvrti stupac.
6. Postupak prema zahtjevu 2, naznačen time, što su prvi, drugi, treći i četvrti stupac povezani sekvencijalnim redoslijedom u nizu ili paralelno.
7. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da prvi stupac smanjuje heterogenost terapijskog proteina smanjenjem udjela osnovnih izoformi terapijskog proteina.
8. Postupak prema zahtjevu 2, naznačen time, da je drugi stupac afinitetni kromatografski stupac.
9. Postupak prema zahtjevu 2, naznačen time, da se svaki od trećeg stupca i četvrtog stupca bira iz skupine koja se sastoji od anionskog izmjenjivačkog kromatografskog stupca, kationskog izmjenjivačkog kromatografskog stupca, hidrofobnog interakcijskog kromatografskog stupca i multimodalnog kromatografskog stupca.
10. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da se terapijski protein bira između antitijela, fragmenta antitijela, monoklonskog antitijela, enzima, konstruiranog proteina, imunogenog proteina, proteinskog fragmenta, imunoglobulina ili bilo koje druge njihove kombinacije.
11. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da se terapijski protein bira iz skupine koju čine: panitumumab, omalizumab, abagovomab, abciksimab, aktoksumab, adalimumab, adekatumumab, afelimomab, afutuzumab, alacizumab, alacizumab, alemtuzumab, alirokumab, altumomab, amatuksimab, amatuksimab, anatumomab, anrukinzumab, apolizumab, arcitumomab, atinumab, tocilizumab, bazilizimab, bektumomab, belimumab, bevacizumab, besilesomab, bezlotoksumab, biciromab, blinatumomab, canakinumab, certolizumab, cetuksimab, ciksutumumab, daclizumab, denosumab, eculizumab, edrekolomab, efalizumab, efungumab, epratuzumab, ertumaksomab, etaracizumab, figitumumab, golimumab, ibritumomab tiuksetan, igovomab, imgatuzumab, infliksimab, inolimomab, inotuzumab, labetuzumab, lebrikizumab, moksetumomab, natalizumab, nivolumab, obinutuzumab, oregovomab, palivizumab, panitumumab,, pertuzumab, ramucirumab, ranibizumab, rituksimab, sekukinumab, tocilizumab, tositumomab, tralokinumab, tukotuzumab, trastuzumab, ustekinumab, vedolizumab, veltuzumab, zalutumumab, zatuksimab, enzimi, proteini, imunogeni ili antigeni proteini ili proteinski fragmenti, alglukozidaza alfa, laronidaza, abatacept, galsulfaza, lutropin alfa, antihemofilni faktor, agalsidaza beta, interferon beta-la, darbepoetin alfa, tenekteplaza, etanercept, faktor koagulacije IX, hormon koji stimulira folikule, interferon beta-la, imigluceraza, dornaza alfa, epoetin alfa, inzulin ili analozi inzulina, mekasermin, faktor VIII, faktor VIIa, anti-trombin III, protein C, humani albumin, eritropoetin, faktor stimuliranja granulokutne kolonije, faktor stimuliranja kolonije granulocitnih makrofaga, interleukin-11, laronidaza, idursufaza, galsulfaza, inhibitor α-1-proteinaze, laktaza, adenozin deaminaza, aktivator plazminogena tkiva, tirotropin alfa, β-galaktozidaza kiselina, β-galaktozidaza, neuraminidaza, heksosaminidaza A, i heksosaminidaza B.
12. Postupak prema zahtjevu 2, nadalje obuhvaća formuliranje poliranog terapijskog proteina u farmaceutski pripravak.
13. Postupak prema zahtjevu 2, naznačen time, da se višestruki kromatografski sustav radi u kontinuiranom načinu.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201621035458 | 2016-10-17 | ||
| PCT/IB2017/056395 WO2018073717A1 (en) | 2016-10-17 | 2017-10-16 | Continuous process for reducing heterogeneity of therapeutic protein |
| EP17804655.3A EP3500586B1 (en) | 2016-10-17 | 2017-10-16 | Continuous process for reducing heterogeneity of therapeutic protein |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210830T1 true HRP20210830T1 (hr) | 2021-08-20 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210830TT HRP20210830T1 (hr) | 2016-10-17 | 2021-05-24 | Kontinuirani proces smanjenja heterogenosti terapijskog proteina |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US11618768B2 (hr) |
| EP (1) | EP3500586B1 (hr) |
| JP (1) | JP6976343B2 (hr) |
| KR (1) | KR102543033B1 (hr) |
| CN (1) | CN109843904A (hr) |
| AU (1) | AU2017345387B2 (hr) |
| DK (1) | DK3500586T3 (hr) |
| EA (1) | EA201990593A1 (hr) |
| ES (1) | ES2876416T3 (hr) |
| HR (1) | HRP20210830T1 (hr) |
| HU (1) | HUE054420T2 (hr) |
| PL (1) | PL3500586T3 (hr) |
| PT (1) | PT3500586T (hr) |
| WO (1) | WO2018073717A1 (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11884698B2 (en) * | 2018-07-02 | 2024-01-30 | Regeneron Pharmaceuticals, Inc. | Systems and methods for preparing a polypeptide from a mixture |
| US20220323937A1 (en) * | 2019-09-24 | 2022-10-13 | Regeneron Pharmaceuticals, Inc. | Systems and methods for chromatography use and regeneration |
| WO2021139720A1 (zh) * | 2020-01-08 | 2021-07-15 | 信达生物制药(苏州)有限公司 | 阿达木单抗纯化方法及其稳定组合物 |
| WO2022066595A1 (en) * | 2020-09-22 | 2022-03-31 | Bristol-Myers Squibb Company | Methods for producing therapeutic proteins |
| CN115475258A (zh) * | 2022-09-06 | 2022-12-16 | 江苏丰华生物制药有限公司 | 一种注射用替奈普酶纯化工艺 |
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| CA1332367C (en) * | 1988-09-28 | 1994-10-11 | Richard Mark Bartholomew | Method for the reduction of heterogeneity of monoclonal antibodies |
| US5126250A (en) | 1988-09-28 | 1992-06-30 | Eli Lilly And Company | Method for the reduction of heterogeneity of monoclonal antibodies |
| BRPI0823004B8 (pt) * | 2008-08-07 | 2021-05-25 | Biocon Ltd | processo para preparação de compostos de insulina |
| EP2450375A1 (en) | 2010-11-09 | 2012-05-09 | Sandoz Gmbh | Cell culture medium and process for protein expression, said medium and process comprising a PAM inhibitor |
| KR101591671B1 (ko) | 2011-04-29 | 2016-02-04 | 바이오콘 리서치 리미티드 | 항체의 이질성을 감소시키는 방법 및 그 항체의 제조방법 |
| US20140371427A1 (en) * | 2011-12-07 | 2014-12-18 | Amgen Inc. | IgG2 DISULFIDE ISOFORM SEPARATION |
| US9181572B2 (en) * | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| US20150267237A1 (en) * | 2012-04-24 | 2015-09-24 | Genentech, Inc. | Cell culture compositions and methods for polypeptide production |
| WO2014137903A2 (en) * | 2013-03-08 | 2014-09-12 | Genzyme Corporation | Integrated continuous manufacturing of therapeutic protein drug substances |
| CN105483193B (zh) * | 2015-11-24 | 2019-03-29 | 上海联合赛尔生物工程有限公司 | 从含酶切位点的融合蛋白中纯化蛋白的方法及试剂盒 |
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| AU2017345387B2 (en) | 2024-09-19 |
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| US11618768B2 (en) | 2023-04-04 |
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| EP3500586B1 (en) | 2021-02-24 |
| JP2019533724A (ja) | 2019-11-21 |
| WO2018073717A1 (en) | 2018-04-26 |
| KR102543033B1 (ko) | 2023-06-12 |
| PT3500586T (pt) | 2021-06-17 |
| JP6976343B2 (ja) | 2021-12-08 |
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