DK2895188T3 - Korrekt foldet etanercept i høj renhed og fremragende udbytte - Google Patents
Korrekt foldet etanercept i høj renhed og fremragende udbytte Download PDFInfo
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- DK2895188T3 DK2895188T3 DK13838016.7T DK13838016T DK2895188T3 DK 2895188 T3 DK2895188 T3 DK 2895188T3 DK 13838016 T DK13838016 T DK 13838016T DK 2895188 T3 DK2895188 T3 DK 2895188T3
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- etanercept
- resin
- protein
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- capto
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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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- 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
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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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- 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
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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]
-
- 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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- 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)
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- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Dermatology (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Claims (14)
- KORREKT FOLDET ETANERCEPT I HØJ RENHED OG FREMRAGENDE UDBYTTE1. Mixed-mode kromatografifremgangsmåde til separering af et korrekt foldet etanercept fra en ukorrekt foldet etanercept omfattende trinnene med: (a) binding af en første etanerceptholdig proteinblanding omfattende både korrekt foldede og ukorrekt foldede konformationer af etanercept til en mixed-mode kromatografiresin med både ionbytterdele og hydrofobe dele; (b) eluering af det korrekt foldede etanercept fra mixed-mode resinen ved at bringe mixed-mode resinen i kontakt med en saltopløsning, så der opnås en anden etanerceptholdig proteinblanding omfattende en højere andel af korrekt foldet etanercept end den første etanerceptblanding.
- 2. Fremgangsmåde ifølge krav 1, hvori mixed-mode kromatografiresinen er en Capto™ MMC mixed-mode kromatografiresin eller Capto™ Adhere mixed-mode kromatografiresin.
- 3. Fremgangsmåde ifølge krav 1, hvori det ukorrekt foldede etanercept udgør mindre end omkring 10 vægt-% af eluatet opnået i trin (b); det korrekt foldede etanercept udgør mere end omkring 90 vægt-% af eluatet opnået i trin (b); og en kombineret mængde af korrekt foldet og ukorrekt foldet etanercept udgør mindst omkring 95 vægt-% af eluatet opnået i trin (b).
- 4. Fremgangsmåde ifølge krav 3, hvori mixed-mode resinen er Capto™ Adhere, og trinnene (a) og (b) udføres ved et pH på omkring 4,5 til omkring 8,5; og saltopløsningen valgfrit endvidere omfatter arginin.
- 5. Fremgangsmåde ifølge krav 3, hvori saltopløsningen appliceres i trin (b) gennem en gradient, hvorved saltkoncentrationen gradvis øges.
- 6. Fremgangsmåde ifølge krav 1, hvori, under trin (b), pH i saltopløsningen, der kommer i kontakt med resinen i trin (b) gradvis ændres.
- 7. Fremgangsmåde ifølge krav 1, hvori mængden af korrekt foldet protein er mindst omkring 70 vægt-% af mængden af protein, der er tilstede i den proteinblanding, der introduceres til resinen i trin (a).
- 8. Fremgangsmåde ifølge krav 1, hvori en proteinblanding omfattende mindst 90 vægt-% korrekt foldet etanercept opnås uden at udføre, eller uden behov for at udføre nogen kromatografiske separations- eller oprensningstrin for at separere korrekt foldet fra ukorrekt foldet etanercept ud over følgende: (1) et eller flere oprensningstrin, hvor sådan(ne) trin alene benyttes til at fjerne ikke-etanercept-baserede urenheder; (2) mixed-mode kromatografitrinnene (a) og (b) fremført i krav 1; og (3) SEC, HIC eller andre analytiske kromatografitrin udført alene med analyseformål.
- 9. Fremgangsmåde ifølge krav 1, hvori fremgangsmåden praktiseres to eller flere gange på følgende måde: udførelse af en første mixed-mode separation (separation nr. 1) ved udførelse af trin (a) og (b); efterfulgt af udførelse af en anden mixed-mode separation (separation nr. 2) ved udførelse af trin (a) og (b) igen; hvori eluatet opnået i trin (b) af separation nr. 1 anvendes som opløsningen indeholdende en proteinblanding i trin (a) af separation nr. 2.
- 10. Fremgangsmåde ifølge krav 9, hvori separation nr. 1 og separation nr. 2 udføres på en måde udvalgt fra følgende kombinationer: Separation nr. 1 anvender CAPTO MMC som mixed-mode kromatografiresin, og Separation nr. 2 anvender CAPTO ADHERE som mixed-mode kromatografiresin; Separation nr. 1 anvender CAPTO ADHERE som mixed-mode kromatografiresin, og separation nr. 2 anvender CAPTO MMC som mixed-mode kromatografiresin; Separation nr. 1 anvender CAPTO MMC som mixed-mode kromatografiresin, og Separation nr. 2 anvender CAPTO MMC som mixed-mode kromatografiresin, eller Separation nr. 1 anvender CAPTO ADHERE som mixed-mode kromatografiresin, og Separation nr. 2 anvender CAPTO ADHERE som mixed-mode kromatografiresin.
- 11. Fremgangsmåde til produktion af en etanerceptholdig proteinblanding med høj renhed med hensyn til mængden af korrekt foldet versus ukorrekt foldet etanercept til stede deri, hvilken fremgangsmåde omfatter trinnene med: (1) at udtrykke etanercept i et pattedyrsekspressionssystem, så der opnås en høstcellekulturvæske indeholdende en etanerceptholdig proteinblanding omfattende både korrekt foldet og ukorrekt foldet etanercept; (2) udsættelse af høstcellekulturvæsken opnået i trin 1 for en oprensningsproces, hvorved der opnås en etanerceptholdig proteinblanding med en reduceret mængde af, eller så godt som fri for, uønskede urenheder til stede i høstcellekulturvæsken produceret i trin (1); (3) at bringe den etanerceptholdige proteinblanding opnået i trin (2) i kontakt en eller flere gange med en mixed-mode kromatografiresin med både ionbytterdele og hydrofobe interaktionsdele for at fastgøre de i blandingen indeholdte proteiner til resinen; og 4) at bringe resinen med protein bundet derpå fra trin 3 i kontakt med en opløsning, så der elueres korrekt foldet etanercept fra mixed-mode resinen, så der opnås et eluat omfattende en etanerceptholdig proteinblanding, der har en højere andel af korrekt foldet etanercept versus ukorrekt foldet etanercept end den etanerceptholdige proteinblanding, der blev introduceret til resinen i trin 3; hvori: (i) mængden af protein, der er til stede i den etanerceptholdige proteinblanding opnået fra oprensning i trin 2 er mindst omkring 80 vægt-% af mængden i den etanerceptbaserede proteinblanding, der er til stede i høstcellekulturvæsken opnået i trin 1. (ii) den kombinerede mængde af korrekt og ukorrekt foldet etanerceptprotein, der er til stede i proteinblandingen elueret i trin 4, er mindst omkring 60 vægt-% af mængden deraf, der er til stede i proteinblandingen opnået fra trin 2; (iii) mængden af korrekt foldet etanercept, der er til stede i eluatet fra trin 4, er mindst omkring 30 vægt-% af mængden af etanerceptholdig proteinblanding, der er til stede i høstcellekulturvæsken opnået i trin 1; og (iv) det korrekt foldede etanercept udgør mindst omkring 90 vægt-% af eluatet opnået i trin 4.
- 12. Fremgangsmåde ifølge krav 11, hvori mixed-mode resinen er udvalgt fra gruppen bestående af CAPTO MMC og CAPTO ADHERE.
- 13. Fremgangsmåde ifølge krav 12 omfattende følgende yderligere trin: Trin (5): at bringe proteinblandingen opnået i eluatet fra trin (4) i kontakt med en mixed-mode kromatografiresin med både ionbytterdele og hydrofobe interaktionsdele for at fastgøre de i blandingen indeholdte proteiner til resinen, og derefter; trin (6) at bringe resinen i kontakt med en opløsning, så der elueres korrekt foldet etanercept derfra, så der opnås et eluat omfattende en proteinblanding med en højere andel af korrekt versus ukorrekt foldet etanercept; hvori den mixed-mode resin, der anvendes i de yderligere trin 5 og 6, er den samme som eller forskellig fra den mixed-mode resin, der anvendes i trin 3 og 4.
- 14. Fremgangsmåde ifølge krav 1, som udelukker anvendelse af single-mode hydrofob interaktionskromatografi som middel til separering af korrekt foldet etanercept fra ukorrekt foldet etanercept, bortset fra når udført alene med analyseformål.
Applications Claiming Priority (2)
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 |
Publications (1)
Publication Number | Publication Date |
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DK2895188T3 true DK2895188T3 (da) | 2018-02-26 |
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DK13838016.7T DK2895188T3 (da) | 2012-09-11 | 2013-09-10 | Korrekt foldet etanercept i høj renhed og fremragende udbytte |
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US (6) | US20140072560A1 (da) |
EP (1) | EP2895188B1 (da) |
JP (3) | JP2015533797A (da) |
KR (2) | KR102133699B1 (da) |
CN (2) | CN110051823A (da) |
AR (1) | AR092532A1 (da) |
AU (2) | AU2013315750B9 (da) |
BR (1) | BR112015005161A2 (da) |
CA (1) | CA2882551A1 (da) |
CL (1) | CL2015000572A1 (da) |
CO (1) | CO7400876A2 (da) |
CY (1) | CY1120062T1 (da) |
DK (1) | DK2895188T3 (da) |
DO (1) | DOP2015000055A (da) |
EA (1) | EA031324B1 (da) |
EC (1) | ECSP15014138A (da) |
ES (1) | ES2657377T3 (da) |
HR (1) | HRP20180182T1 (da) |
HU (1) | HUE036524T2 (da) |
IL (2) | IL237311B (da) |
IN (1) | IN2015KN00452A (da) |
LT (1) | LT2895188T (da) |
MX (2) | MX360044B (da) |
NO (1) | NO2972131T3 (da) |
PE (2) | PE20200607A1 (da) |
PL (1) | PL2895188T3 (da) |
PT (1) | PT2895188T (da) |
RS (1) | RS57013B1 (da) |
SG (1) | SG11201501460RA (da) |
SI (1) | SI2895188T1 (da) |
TW (2) | TWI716649B (da) |
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