SI2895188T1 - Pravilno zvit etanercept z visoko čistočo in odličnim izkoristkom - Google Patents
Pravilno zvit etanercept z visoko čistočo in odličnim izkoristkom Download PDFInfo
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- SI2895188T1 SI2895188T1 SI201330936T SI201330936T SI2895188T1 SI 2895188 T1 SI2895188 T1 SI 2895188T1 SI 201330936 T SI201330936 T SI 201330936T SI 201330936 T SI201330936 T SI 201330936T SI 2895188 T1 SI2895188 T1 SI 2895188T1
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- C—CHEMISTRY; METALLURGY
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- 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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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- 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
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- 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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- 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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- 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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Claims (14)
- Pravilno zvit etanercept z visoko čistoto in odličnim izkoristkom Patentni zahtevki1. Kromatografski postopek z mešanim načinom za ločevanje pravilno zvitega etanercepta od nepravilno zvitega etanercepta, ki obsega koraka: (a) vezavo prve beljakovinske zmesi, ki vsebuje etanercept in obsega pravilno zvite in nepravilno zvite konformacije etanercepta na smolo kromatografije z mešanim načinom, ki ima tako ionske izmenjevalne dele kot tudi hidrofobne dele; (b) eluiranje pravilno zvitega etanercepta iz smole mešanega načina z dajanjem smole mešanega načina v stik z raztopino soli, da dobimo drugo beljakovinsko zmes, ki vsebuje etanercept in obsega večji delež pravilno zvitega etanercepta kot prva zmes etanercepta.
- 2. Postopek po zahtevku 1, pri čemer je smola za kromatografijo mešanega načina Capto™ MMC ali Capto™ Adhere.
- 3. Postopek po zahtevku 1, pri čemer nepravilno zviti etanercept predstavlja manj kot okoli 10 mas. % eluata, dobljenega v koraku (b); pravilno zviti etanercept predstavlja več kot okoli 90 mas. % eluata, dobljenega v koraku (b); in kombinirana količina pravilno zvitega in nepravilno zvitega etanercepta predstavlja vsaj okoli 95 mas. % eluata, dobljenega v koraku (b).
- 4. Postopek po zahtevku 3, pri čemer je smola mešanega načina Capto™ Adhere in koraka (a) in (b) se izvedeta pri pH od okoli 4,5 do okoli 8,5; in raztopina soli po izbiri dalje obsega arginin.
- 5. Postopek po zahtevku 3, pri čemer se raztopina soli uporabi v koraku (b) z gradientom, s čimer se koncentracija soli postopno poveča.
- 6. Postopek po zahtevku 1, pri čemer se v koraku (b) pH raztopine soli, ki pride v stik s smolo v koraku b), postopno spremeni.
- 7. Postopek po zahtevku 1, pri čemer je količina pravilno zvite beljakovine vsaj okoli 70 mas. % količine beljakovine, ki je prisotna v beljakovinski zmesi, ki se uvede v smolo v koraku (a).
- 8. Postopek po zahtevku 1, pri čemer beljakovinsko zmes, ki obsega vsaj 90 mas. % pravilno zvitega etanercepta, dobimo brez izvajanja ali brez potrebe po izvajanju kakršnega koli koraka kromatografskega ločevanja ali čiščenja, da ločimo pravilno zviti etanercept od nepravilno zvitega, razen naslednjih: (1) enega ali več korakov čiščenja, kjer se takšen(-ni) korak(-i) uporabi(-jo) samo za odstranitev nečistot, ki niso na bazi etanercepta; (2) kromatografskih korakov (a) in (b) mešanega načina po zahtevku 1; in (3) SEC, HIC ali drugih analitičnih kromatografskih korakov, ki se opravijo samo za namene analize.
- 9. Postopek po zahtevku 1, pri čemer se postopek izvede dvakrat ali večkrat na naslednji način: izvajanje prvega ločevanja mešanega načina (ločevanje št. 1) z izvajanjem korakov (a) in (b); čemur sledi izvajanje drugega ločevanja mešanega načina (ločevanje št. 2) z ponovnim izvajanjem korakov (a) in (b); pri čemer se eluat, dobljen v koraku (b) ločevanja št. 1 uporabi kot raztopina, ki vsebuje beljakovinsko zmes v koraku (a) ločevanja št. 2.
- 10. Postopek po zahtevku 9, pri čemer se ločevanje št. 1 in ločevanje št. 2 opravita na način, izbran izmed naslednjih kombinacij: pri ločevanju št. 1 se uporabi CAPTO MMC kot kromatografska smola mešanega načina in pri ločevanju št. 2 se uporabi CAPTO ADHERE kot kromatografska smola mešanega načina; pri ločevanju št. 1 se uporabi CAPTO ADHERE kot kromatografska smola mešanega načina in pri ločevanju št. 2 se uporabi CAPTO MMC kot kromatografska smola mešanega načina; pri ločevanju št. 1 se uporabi CAPTO MMC kot kromatografska smola mešanega načina in pri ločevanju št. 2 se uporabi CAPTO MMC kot kromatografska smola mešanega načina; ali pri ločevanju št. 1 se uporabi CAPTO ADHERE kot kromatografska smola mešanega načina in pri ločevanju št. 2 se uporabi CAPTO ADHERE kot kromatografska smola mešanega načina.
- 11. Postopek za izdelavo beljakovinske zmesi, ki vsebuje etanercept in ima visoko čistoto glede na količino pravilno zvitega proti nepravilno zvitemu etanerceptu, ki je v njej prisoten, pri čemer postopek obsega korake: (1) izražanje etanercepta v sesalskem ekspresijskem sistemu, da dobimo tekočino pobrane celične kulture, ki vsebuje beljakovinsko zmes, ki vsebuje etanercept, ki obsega tako pravilno zviti in nepravilno zviti etanercept; (2) izpostavljanje tekočine pobrane celične kulture, dobljene v koraku 1, očiščevalnemu procesu, s čimer dobimo beljakovinsko zmes, ki vsebuje etanercept z zmanjšano količino neželenih nečistot ali v bistvu brez nečistot, prisotnih v tekočini pobrane celične kulture, pridobljene v koraku (1); (3) dajanje beljakovinske zmesi, ki vsebuje etanercept, dobljene v koraku (2) enkrat ali večkrat v stik s kromatografsko smolo mešanega načina, ki ima tako ionsko izmenjevalne dele kot tudi hidrofobne interakcijske dele, da se beljakovine, vsebovane v zmesi, pritrdijo na smolo; in (4) dajanje smole, ki ima na sebi vezano beljakovino iz koraka 3, v stik z raztopino za eluiranje pravilno zvitega etanercepta iz smole mešanega načina, da dobimo eluat, ki obsega beljakovinsko zmes, ki vsebuje etanercept, ki ima večji delež pravilno zvitega etanercepta glede na nepravilno zviti etanercept kot zmes, ki vsebuje etanercept, uvedena v smolo v koraku 3; pri čemer: (i) količina beljakovine, prisotne v beljakovinski zmesi, ki vsebuje etanercept in je bila pridobljena iz očiščevanja iz koraka 2, je vsaj okoli 80 mas. % beljakovinske zmesi na bazi etanercepta, ki je prisotna v tekočini pobrane celične kulture, dobljeni v koraku 1. (ii) kombinirana količina pravilno in nepravilno zvite etanerceptne beljakovine, prisotne v beljakovinski zmesi, ki je bila eluirana v koraku 4, je vsaj okoli 60 mas. % količine le-te v beljakovinski zmesi, dobljeni v koraku 2; (iii) količina pravilno zvitega etanercepta, prisotnega v eluatu iz koraka 4, je vsaj okoli 30 mas. % količine beljakovinske zmesi, ki vsebuje etanercept, ki je prisotna v tekočini pobrane celične kulture, dobljeni v koraku 1; in (iv) pravilno zviti etanercept predstavlja vsaj okoli 90 mas. % eluata, dobljenega v koraku 4.
- 12. Postopek po zahtevku 11, pri čemer je smola mešanega načina izbrana iz skupine, ki sestoji iz CAPTO MMC in CAPTO ADHERE.
- 13. Postopek po zahtevku 12, ki obsega naslednja dodatna koraka: Korak (5): dajanje beljakovinske zmesi, dobljene v eluatu v koraku (4) v stik s kromatografsko smolo mešanega načina, ki ima tako ionsko izmenjevalne dele kot tudi hidrofobne interakcijske dele, da se beljakovine, vsebovane v zmesi, pritrdijo na smolo, in potem: korak (6) dajanje smole v stik z raztopino za eluiranje pravilno zvitega etanercepta iz nje, da dobimo eluat, ki obsega beljakovinsko zmes, ki ima večji delež pravilno zvitega etanercepta glede na nepravilno zviti etanercept; pri čemer je smola mešanega načina, ki je uporabljena v korakih 5 in 6, enaka ali drugačna od smole mešanega načina, ki je uporabljena v korakih 3 in 4.
- 14. Postopek po zahtevku 1, ki izključuje uporabo hidrofobne interakcijske kromatografije enega samega načina kot sredstvo za ločevanje pravilno zvitega etanercepta od nepravilno zvitega etanercepta, razen kadar se izvaja samo za namene 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 |
|---|---|
| SI2895188T1 true SI2895188T1 (sl) | 2018-05-31 |
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| Application Number | Title | Priority Date | Filing Date |
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| SI201330936T SI2895188T1 (sl) | 2012-09-11 | 2013-09-10 | Pravilno zvit etanercept z visoko čistočo in odličnim izkoristkom |
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| US (6) | US20140072560A1 (sl) |
| EP (1) | EP2895188B1 (sl) |
| JP (3) | JP2015533797A (sl) |
| KR (2) | KR102250937B1 (sl) |
| CN (2) | CN110051823A (sl) |
| AR (1) | AR092532A1 (sl) |
| AU (2) | AU2013315750B9 (sl) |
| BR (1) | BR112015005161A2 (sl) |
| CA (1) | CA2882551A1 (sl) |
| CL (1) | CL2015000572A1 (sl) |
| CO (1) | CO7400876A2 (sl) |
| CY (1) | CY1120062T1 (sl) |
| DK (1) | DK2895188T3 (sl) |
| DO (1) | DOP2015000055A (sl) |
| EA (1) | EA031324B1 (sl) |
| EC (1) | ECSP15014138A (sl) |
| ES (1) | ES2657377T3 (sl) |
| HR (1) | HRP20180182T1 (sl) |
| HU (1) | HUE036524T2 (sl) |
| IL (2) | IL237311B (sl) |
| IN (1) | IN2015KN00452A (sl) |
| LT (1) | LT2895188T (sl) |
| MX (2) | MX360044B (sl) |
| NO (1) | NO2972131T3 (sl) |
| PE (2) | PE20200607A1 (sl) |
| PL (1) | PL2895188T3 (sl) |
| PT (1) | PT2895188T (sl) |
| RS (1) | RS57013B1 (sl) |
| SG (1) | SG11201501460RA (sl) |
| SI (1) | SI2895188T1 (sl) |
| TW (2) | TWI609877B (sl) |
| WO (1) | WO2014043103A1 (sl) |
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| CN114917185B (zh) | 2016-10-21 | 2023-11-14 | 美国安进公司 | 药物配制品及其制备方法 |
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| 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 |
| US20240156907A1 (en) * | 2021-03-16 | 2024-05-16 | Kashiv Biosciences, Llc | Novel formulation of fusion protein |
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