HRP20180182T1 - Pravilno presavijeni etanercept visoke čistoće i izvanrednog prinosa - Google Patents
Pravilno presavijeni etanercept visoke čistoće i izvanrednog prinosa Download PDFInfo
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- HRP20180182T1 HRP20180182T1 HRP20180182TT HRP20180182T HRP20180182T1 HR P20180182 T1 HRP20180182 T1 HR P20180182T1 HR P20180182T T HRP20180182T T HR P20180182TT HR P20180182 T HRP20180182 T HR P20180182T HR P20180182 T1 HRP20180182 T1 HR P20180182T1
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- etanercept
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- 108010008165 Etanercept Proteins 0.000 title claims 36
- 229960000403 etanercept Drugs 0.000 title claims 35
- 239000011347 resin Substances 0.000 claims 28
- 229920005989 resin Polymers 0.000 claims 28
- 239000000203 mixture Substances 0.000 claims 25
- 108090000623 proteins and genes Proteins 0.000 claims 23
- 102000004169 proteins and genes Human genes 0.000 claims 23
- 238000000034 method Methods 0.000 claims 17
- 238000000926 separation method Methods 0.000 claims 16
- 239000013019 capto adhere Substances 0.000 claims 5
- 239000012930 cell culture fluid Substances 0.000 claims 5
- 239000012266 salt solution Substances 0.000 claims 4
- 230000002209 hydrophobic effect Effects 0.000 claims 3
- 238000005342 ion exchange Methods 0.000 claims 3
- 238000000746 purification Methods 0.000 claims 3
- 239000000243 solution Substances 0.000 claims 3
- 238000011210 chromatographic step Methods 0.000 claims 2
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 2
- 239000012535 impurity Substances 0.000 claims 2
- 230000003993 interaction Effects 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 1
- 238000004458 analytical method Methods 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 238000013375 chromatographic separation Methods 0.000 claims 1
- 238000011097 chromatography purification Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
Classifications
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- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
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- Animal Behavior & Ethology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Toxicology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Analytical Chemistry (AREA)
- Rheumatology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (14)
1. Mješoviti kromatografski postupak za odvajanje ispravno presavijenog etanercepta od nepravilno presavijenog etanercepta, koji sadrži korake:
(a) vezanje prve mješavine proteina koja sadrži etanercept i to pravilno presavijenu i nepravilno presavijenu konformaciju etanercepta za mješovitu kromatografsku smolu koja ima obje ionske izmjene, i hidrofobne radikale;
(b) eluiranje ispravno presavijenog etanercepta iz smjese smole dovođenjem u kontakt mješavine smole s otopinom soli da se dobije druga mješavina proteina koja sadrži etanercept, a koja sadrži veći udio pravilno presavijenog etanercepta od prve mješavine etanercepta.
2. Postupak sukladno zahtjevu 1, naznačen time da je smjesa miješane kromatografske smole CaptoTM MMC mješovita kromatografska smola ili CaptoTM Adhere mješovita kromatografska smola.
3. Postupak sukladno zahtjevu 1, pri čemu nepravilno savijeni etanercept čini manje od oko 10 tež. % eluata dobivenog u koraku (b); pravilno savijeni etanercept čini više od oko 90 tež. % eluata dobivenog u koraku (b); i kombinirana količina pravilno savijenog i nepravilno savijenog etanercepta čini najmanje oko 95 tež. % eluata dobivenog u koraku (b).
4. Postupak sukladno zahtjevu 3, pri čemu je mešovita smola CaptoTM Adhere i koraci (a) i (b) se izvode na pH od oko 4.5 do oko 8.5; navedena otopina soli opcionalno nadalje sadrži arginin.
5. Postupak sukladno zahtjevu 3, pri čemu se otopina soli primenjuje u koraku (b) kroz gradijent, pri čemu se koncentracija soli postupno povećava.
6. Postupak sukladno zahtjevu 1, pri čemu se tijekom koraka (b) pH otopine soli koja se dodiruje sa smolom u koraku (b) postupno mijenja.
7. Postupak sukladno zahtjevu 1, pri čemu je količina pravilno savijenog proteina najmanje oko 70 tež. % količine proteina prisutnih u mješavini proteina uvedenim u smolu u koraku (a).
8. Postupak sukladno zahtjevu 1, pri čemu se mješavina proteina koja sadrži najmanje 90 tež. % pravilno savijenog etanercepta dobiva bez provođenja, ili bez potrebe za provođenjem bilo kakvih koraka kromatografskog odvajanja ili pročišćavanja da bi se odvajali pravilno presavijeni od nepravilno presavijenog etanercepta, osim sledećih:
(1) jedan ili više koraka pročišćavanja, gdje se takav korak, odn. koraci upotrebljavaju isključivo za uklanjanje nečistoća koje nisu bazirane na etanerceptu;
(2) kromatografske korake (a) i (b) mješovitog načina iz zahtjeva 1; i
(3) SEC, HIC ili druge analitičke kromatografske korake izvedene isključivo u svrhu analize.
9. Postupak sukladno zahtjevu 1, pri čemu se postupak provodi dva ili više puta na slijedeći način:
obavljajući prvo razdvajanje mješovitog način (odvajanje #1) izvođenjem koraka (a) i (b); praćenim izvođenjem drugog razdvajanja mješovitom modu (odvajanje #2): ponovnim postupcima (a) i (b);
pri čemu se eluat dobiven u koraku (b) odvajanje #1 koristi kao otopina koji sadrži mješavinu proteina u koraku (a) odvajanja #2.
10. Postupak sukladno zahtjevu 9, pri čemu se odvajanje #1 i odvajanje #2 izvode na način koji odabran između slijedećih kombinacija:
Odvajanje # 1 koristi CAPTO MMC kao mješoviti način kromatografske smole i
Odvajanje # 2 koristi CAPTO ADHERE kao način kromatografske smole;
Odvajanje # 1 koristi CAPTO ADHERE kao način kromatografske smole i Odvajanje # 2 koristi CAPTO MMC kao način kromatografske smole;
Odvajanje # 1 koristi CAPTO MMC kao način kromatografske smole i
Odvajanje # 2 koristi CAPTO MMC kao način kromatografske smole; ili
Odvajanje # 1 koristi CAPTO ADHERE kao način kromatografske smole i
Odvajanje # 2 koristi CAPTO ADHERE kao način kromatografske smole.
11. Postupak za proizvodnju mješavine proteina koja sadrži etanercept i ima visoku čistoću s obzirom na količinu pravilno presavijenog prema nepravilno presavijenom etanerceptu prisutnu u njoj, navedeni postupak obuhvaća korake:
(1) ekspresirajući etanercept u ekspresijskom sustavu sisavaca čime se dobiva tekućina stanične kulture koja sadrži mješavinu proteina koja sadrži etanercept, a koja sadrži i pravilno presavijeni, i nepravilno presavijeni etanercept;
(2) podvrgavanja tekućine sakupljenih staničnih kultura dobivenog u koraku 1 postupku pročišćavanja, pri čemu se dobiva smjesa proteina koja sadrži etanercept s reduciranom količinom ili u biti slobodnom od neželjnih nečistoća prisutnih u tekućini sakupljenih staničnih kultura proizvedenom u koraku (1);
(3) dovođenja u kontakt mješavine proteina dobivene u koraku (2) koja sadrži etanercept jednom ili više puta s mješovitom kromatografskom smolom koja ima obje ionske izmjene i dijelove hidrofobne interakcije kako bi se proteini koji su sadržani u smjesi vezali za smolu; i
4) dovođenja u dodir sa smolom koja ima vezan protein na koraka 3 s otopinom da eluira pravilno presavijenog etanercepta iz mješovite smole radi dobivanja eluata koji sadrži mješavinu proteina koji ima veći udio pravilno presavijenog etanercepta u odnosu na nepravilno presavijeni etanercept od mješavine koja sadrži etanercept uvedene u smolu u koraku 3;
pri čemu:
(i) količina proteina prisutnog u mješavini proteina koja sadrži etanercept dobiven pročišćavanjem iz koraka 2 je najmanje oko 80 tež. % količine mješavine proteina na osnovi etanercepta prisutnog u tekućini prikupljenih kultura stanica dobivenom u koraku 1.
(ii) kombininrana količina pravilno i nepravilno presavijenog proteina etanercepta prisutnog umješavini proteina eluiranog u koraku 4 je najmanje oko 60 tež. % njegove količine prisutne u mješavini proteina dobivenoj u koraku 2;
(iii) količina pravilno presavijenog etanercepta prisutnog u eluatu iz koraka 4 je najmanje oko 30 tež. % količine mješavine proteina koja sadrži etanercept prisutne u tekućini prikupljenih kultura stanica dobivenom u koraku 1; i
(iv) spomenuti pravilno presavijeni etanercept čini najmanje oko 90 tež. % eluata dobivenog u koraku 4.
12. Postupak sukladno zahtjevu 11, pri čemu je mješavina smole odabrane iz grupe koja se sastoji od CAPTO MMC i CAPTO ADHERE.
13. Postupak sukladno zahtjevu 12, koji sadrži slijedeće dodatne korake:
Korak (5): dovođenje u kontakt smjese proteina dobivene u eluatu iz koraka 4 s mješovitom kromatografskom smolom koja ima obje ionske izmjene, i dijelove hidrofobne interakcije da bi se proteini sadržani u sjmesi vezali za smolu, a zatim;
korak (6) dovođenja u kontakt smole s otopinom da bi se eluirao pravilno presavijeni etanercept iz nje da bi se dobio eluat koji sadrži smjesu proteina koja ima veći udio pravilno presavijenog u odnosu na nepravilno presavijeni etanercept;
pri čemu je mješovita smola koja se upotrebljava u navedenim dodatnim koracima 5 i 6 ista ili različita od mješovite smole upotrebljene u koracima 3 i 4.
14. Postupak sukladno zahtjevu 1, koji isključuje upotrebu jednostruke hidrofobne interakcije kromatografije kao sredstvo odvajanja pravilno presavijenog etanercepta od nepravilno presavijenog etanercepta, izuzev kada se izvodi isključivo za svrhe analize.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261699552P | 2012-09-11 | 2012-09-11 | |
| EP13838016.7A EP2895188B1 (en) | 2012-09-11 | 2013-09-10 | Correctly folded etanercept in high purity and excellent yield |
| PCT/US2013/058994 WO2014043103A1 (en) | 2012-09-11 | 2013-09-10 | Correctly folded etanercept in high purity and excellent yield |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180182T1 true HRP20180182T1 (hr) | 2018-04-20 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180182TT HRP20180182T1 (hr) | 2012-09-11 | 2018-01-31 | Pravilno presavijeni etanercept visoke čistoće i izvanrednog prinosa |
Country Status (32)
| Country | Link |
|---|---|
| US (6) | US20140072560A1 (hr) |
| EP (1) | EP2895188B1 (hr) |
| JP (3) | JP2015533797A (hr) |
| KR (2) | KR102133699B1 (hr) |
| CN (2) | CN110051823A (hr) |
| AR (1) | AR092532A1 (hr) |
| AU (2) | AU2013315750B9 (hr) |
| BR (1) | BR112015005161A2 (hr) |
| CA (1) | CA2882551A1 (hr) |
| CL (1) | CL2015000572A1 (hr) |
| CO (1) | CO7400876A2 (hr) |
| CY (1) | CY1120062T1 (hr) |
| DK (1) | DK2895188T3 (hr) |
| DO (1) | DOP2015000055A (hr) |
| EA (1) | EA031324B1 (hr) |
| EC (1) | ECSP15014138A (hr) |
| ES (1) | ES2657377T3 (hr) |
| HR (1) | HRP20180182T1 (hr) |
| HU (1) | HUE036524T2 (hr) |
| IL (2) | IL237311B (hr) |
| IN (1) | IN2015KN00452A (hr) |
| LT (1) | LT2895188T (hr) |
| MX (2) | MX360044B (hr) |
| NO (1) | NO2972131T3 (hr) |
| PE (2) | PE20150996A1 (hr) |
| PL (1) | PL2895188T3 (hr) |
| PT (1) | PT2895188T (hr) |
| RS (1) | RS57013B1 (hr) |
| SG (1) | SG11201501460RA (hr) |
| SI (1) | SI2895188T1 (hr) |
| TW (2) | TWI716649B (hr) |
| WO (1) | WO2014043103A1 (hr) |
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| MX2014004725A (es) | 2011-10-18 | 2015-02-05 | Coherus Biosciences Inc | Formulaciones de etanercept estabilizadas con aminoacidos. |
| US10493151B2 (en) | 2011-10-18 | 2019-12-03 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with sodium chloride |
| CN110051823A (zh) * | 2012-09-11 | 2019-07-26 | 科荣生生物科学公司 | 高纯度和优异产量的正确折叠的依那西普 |
| MX2016016318A (es) * | 2014-06-13 | 2017-06-12 | Lupin Atlantis Holdings Sa | Proceso para la purificacion de la proteina de fusion. |
| EP2975050B1 (en) * | 2014-07-18 | 2019-05-29 | Sandoz Ag | Quantification of misfolded TNFR2:Fc |
| BR112017014224A2 (pt) | 2014-12-31 | 2018-03-06 | Lg Chem, Ltd. | método para a preparação de proteína de fusão fc-tnfr que contém teor alvo de impurezas |
| KR20170138426A (ko) | 2015-03-13 | 2017-12-15 | 삼성바이오에피스 주식회사 | 항-tnf-알파 폴리펩티드 조성물 및 그 용도 |
| KR20180083409A (ko) * | 2015-11-18 | 2018-07-20 | 메르크 파텐트 게엠베하 | 이온 교환 크로마토그래피에서의 개선된 단백질 분리 |
| CN108350027A (zh) * | 2015-11-18 | 2018-07-31 | 默克专利股份公司 | 用于改进的蛋白质分离的相反的pH-盐梯度 |
| TWI798179B (zh) * | 2016-06-17 | 2023-04-11 | 美商建南德克公司 | 多特異性抗體之純化 |
| CN109982685B (zh) * | 2016-10-21 | 2022-03-11 | 美国安进公司 | 药物配制品及其制备方法 |
| MX2019011343A (es) * | 2017-03-24 | 2019-11-18 | Council Scient Ind Res | Un procedimiento para la purificacion de fragmentos de anticuerpos recombinantes. |
| US11253569B2 (en) | 2018-05-03 | 2022-02-22 | Seattle Children's Hospital | Methods of treating Kawasaki Disease |
| CN112876567A (zh) * | 2019-11-29 | 2021-06-01 | 广东菲鹏制药股份有限公司 | Fc融合蛋白及其纯化方法 |
| WO2022195505A1 (en) * | 2021-03-16 | 2022-09-22 | Kashiv Biosciences, Llc | Novel formulation of fusion protein |
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