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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- 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
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- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- 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
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- A61P17/00—Drugs for dermatological disorders
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- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- 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]
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- 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
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- 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
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- 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
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- 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
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- 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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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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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 | |
| PCT/US2013/058994 WO2014043103A1 (en) | 2012-09-11 | 2013-09-10 | Correctly folded etanercept in high purity and excellent yield |
| EP13838016.7A EP2895188B1 (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 | 2013-09-10 | Pravilno presavijeni etanercept visoke čistoće i izvanrednog prinosa |
Country Status (33)
| 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) |
| SM (1) | SMT201800163T1 (hr) |
| TW (2) | TWI716649B (hr) |
| WO (1) | WO2014043103A1 (hr) |
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| CA3026518A1 (en) * | 2016-06-17 | 2017-12-21 | Genentech, Inc. | Purification of multispecific antibodies |
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| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| BR112019019613A2 (pt) * | 2017-03-24 | 2020-04-14 | Council Scient Ind Res | processo para a purificação de fragmentos de anticorpos recombinantes |
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