HRP20141109T1 - Postupak za pripravu obogaä†enog sastava igg iz plazme - Google Patents

Postupak za pripravu obogaä†enog sastava igg iz plazme Download PDF

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HRP20141109T1
HRP20141109T1 HRP20141109AT HRP20141109T HRP20141109T1 HR P20141109 T1 HRP20141109 T1 HR P20141109T1 HR P20141109A T HRP20141109A T HR P20141109AT HR P20141109 T HRP20141109 T HR P20141109T HR P20141109 T1 HRP20141109 T1 HR P20141109T1
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value
precipitation
solution
precipitate
buffer
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HRP20141109AT
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Leopold Bruckschwaiger
Sonja Svatos
Julia NÜRNBERGER
Wolfgang Teschner
Harald Arno Butterweck
Hans-Peter Schwarz
Thomas Gundinger
Bernhard Koelbl
Reinhard Grausenburger
Azra Pljevljakovic
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Baxter International Inc.
Baxter Healthcare S.A.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42727304&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20141109(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter International Inc., Baxter Healthcare S.A. filed Critical Baxter International Inc.
Publication of HRP20141109T1 publication Critical patent/HRP20141109T1/hr

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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • B01D15/08—Selective adsorption, e.g. chromatography
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    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
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    • B01D15/08—Selective adsorption, e.g. chromatography
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    • B01D15/361—Ion-exchange
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    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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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
    • C07K1/30—Extraction; Separation; Purification by precipitation
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • 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
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
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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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis

Claims (36)

1. Postupak za pripravu obogaćenog sastava IgG iz plazme, naznačen time, da taj postupak obuhvaća sljedeće korake: (a) taloženje kriosiromašne frakcije plazme, u prvom koraku taloženja, s oko 6% do oko 10% alkohola uz pH-vrijednost između oko 7,0 i oko 7,5, za dobivanje prvog taloga i prvoga dijela koji pliva na površini; (b) taloženje IgG iz prvog dijela koji pliva na površini, u drugom koraku taloženja, s oko 20% do oko 25% alkohola uz pH-vrijednost između oko 6,7 i oko 7,3, za tvorbu drugog taloga; (c) re-suspendiranje drugog taloga za tvorbu suspenzije; (d) taloženje IgG iz suspenzije stvorene u koraku (c), u trećem koraku taloženja, s oko 22% do oko 28% alkohola uz pH-vrijednost između oko 6,7 i oko 7,3 za tvorbu trećeg taloga; (e) re-suspendiranje trećeg taloga za tvorbu suspenzije; i (f) odvajanje otopive frakcije iz suspenzije stvorene u koraku (e), čime se pripravlja obogaćeni sastav IgG, pri čemu barem jedan od prvog koraka taloženja, drugog koraka taloženja ili trećeg koraka taloženja, obuhvaća dodatno raspršivanje alkohola.
2. Postupak prema zahtjevu 1, naznačen time, da svi koraci - prvi korak taloženja, drugi korak taloženja i treći korak taloženja, sadrže dodatno raspršivanje alkohola.
3. Postupak prema zahtjevu 1 ili 2, naznačen time, da pH-vrijednost u barem jednom od prvog koraka taloženja, drugog koraka taloženja i trećeg koraka taloženja, postiže se dodavanjem pH-modificirane otopine nakon dodavanja alkohola.
4. Postupak prema bilo kojem od zahtjeva1 do 3, naznačen time, da pH-vrijednost u svim koracima - prvom koraku taloženja, drugom koraku taloženja i trećem koraku taloženja, postiže se dodavanjem pH-modificirane otopine nakon dodavanja alkohola.
5. Postupak prema zahtjevu 3 ili 4, naznačen time, da dodavanje pH-modificirane otopine obuhvaća dodatno raspršivanje pH-modificirane otopine.
6. Postupak prema bilo kojem od zahtjeva 3 do 5, naznačen time, da se pH-vrijednost u koraku taloženja modificira prije i poslije dodavanja alkohola, za vrijeme i nakon dodavanja alkohola, ili prije, za vrijeme i nakon dodavanja alkohola.
7. Postupak prema bilo kojem od zahtjeva 1 do 6, naznačen time, da se pH-vrijednost u barem jednom od koraka taloženja održava za vrijeme cijelog trajanja taloženja, pomoću stalnog podešavanja pH-vrijednosti.
8. Postupak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da postupak nadalje obuhvaća korak kromatografskog pročišćavanja izmjenom iona.
9. Postupak prema zahtjevu 8, naznačen time, da postupak obuhvaća i korak kromatografskog pročišćavanja izmjenom aniona i korak kromatografskog pročišćavanja izmjenom kationa.
10. Postupak prema bilo kojem od zahtjeva 1 do 9, naznačen time, da postupak nadalje obuhvaća korak nanofiltriranja i/ili korak ultrafiltriranja/diafiltriranja.
11. Postupak prema bilo kojem od zahtjeva 1 do 10, naznačen time, da obogaćeni sastav IgG dobiven u koraku (f), obuhvaća najmanje 85%, poželjno najmanje 90% od sadržaja IgG pronađenog u kriosiromašnoj frakciji plazme koja se upotrebljava u koraku (a).
12. Postupak prema bilo kojem od zahtjeva 1 do 11, naznačen time, da je čistoća γ-globulina u konačnom sastavu IgG barem oko 95%, poželjno barem oko 98%, najbolje barem oko 99%.
13. Postupak prema zahtjevu 1, naznačen time, da postupak obuhvaća sljedeće korake: a) namještanje pH-vrijednosti kriosiromašne frakcije plazme na oko 7,0; b) namještanje koncentracije etanola u kriosiromašnoj frakciji plazme iz koraka (a) na oko 25% (v/v) uz temperaturu od oko -7°C do oko -9°C, čime se tvori smjesa; c) odvajanje tekućine i taloga iz smjese u koraku (b); d) re-suspendiranje taloga iz koraka (c) s puferom koji sadrži fosfat i acetat, pri čemu je pH-vrijednost pufera namještena s 300 mL do 700 mL glacijalne octene kiseline po 1000 mL pufera, čime se tvori suspenzija; e) miješanje konačno razdvojenog silicijevog dioksida (SiO2) sa suspenzijom iz koraka (d) u vremenu od najmanje oko 30 minuta; f) filtriranje suspenzije s filter-prešom, čime se tvori filtrat; g) ispiranje filter-preše s najmanje 3 prazna volumena filter-preše od pufera koji sadrži fosfat i acetat, pri čemu se pH-vrijednost pufera namješta s 50 mL do 200 mL glacijalne octene kiseline po 1000 mL pufera, čime se tvori otopina za pranje; h) kombiniranje filtrata iz koraka (f) s otopinom za pranje iz koraka (g), čime se tvori otopina, te se ta otopina tretira s deterdžentom; i) namještanje pH-vrijednosti otopine iz koraka (h) na oko 7,0 i dodavanje etanola za konačnu koncentraciju od oko 25%, čime se tvori talog; j) odvajanje tekućine i taloga od smjese iz koraka (i); k) otapanje taloga u vodenoj otopini koja sadrži otapalo ili deterdžent i održavanje otopine u vremenu od najmanje 60 minuta; l) prelaženje otopine nakon koraka (k) kroz izmjenu kationa na kromatografskom stupcu i kroz eluaciju proteina koji se apsorbiraju na stupcu u eluatu; m) prelaženje eluata iz koraka (l) kroz izmjenu aniona na kromatografskom stupcu u svrhu generiranja efluenta; n) prelaženje efluenta iz koraka (m) kroz nanofilter u svrhu generiranja nanofiltrata; o) prelaženje nanofiltrata iz koraka (n) kroz membranu za ultrafiltriranje u svrhu generiranja ultrafiltrata; i p) diafiltriranje ultrafiltrata iz koraka (o) preko diafiltracijskog pufera za generiranje diafiltrata koji ima koncentraciju pufera između oko 8% (w/v) i oko 12% (w/v), čime se dobiva sastav koncentriranog IgG.
14. Postupak prema zahtjevu 13, naznačen time, da se koncentracija podešava u barem jednom od koraka (b) i (i) uvođenjem etanola u frakciju pomoću raspršivanja.
15. Postupak prema zahtjevu 13 ili 14, naznačen time, da se pH-vrijednost namješta na prikladnu pH-vrijednost nakon dodavanja etanola u barem jednom od koraka (b) i (i).
16. Postupak prema zahtjevu 15, naznačen time, da se pH-vrijednost održava za vrijeme trajanja cijele reakcije taloženja pomoću namještanja pH-vrijednosti u barem jednom od koraka (b) i (i).
17. Postupak prema bilo kojem od zahtjeva 13 do 16, naznačen time, da se pH-vrijednost namješta u barem jednom od koraka pomoću raspršivanja otopine kojom se može podesiti pH-vrijednost.
18. Postupak prema zahtjevu 17, naznačen time, da se pH-vrijednost namješta raspršivanjem glacijalne octene kiseline.
19. Postupak prema bilo kojem od zahtjeva 13 do 18, naznačen time, da postupak nadalje obuhvaća filtriranje diafiltrata kroz filter od 0,22 µm ili manje.
20. Postupak prema bilo kojem od zahtjeva 13 do 19, naznačen time, da plazma je ljudska plazma.
21. Postupak prema bilo kojem od zahtjeva 13 do 20, naznačen time, da se kriosiromašna frakcija plazme pripravlja putem postupka koji obuhvaća sljedeće korake: a) hlađenje kombinirane sakupljene donirane plazme na temperaturu od oko 2°C do oko 10°C; b) odvajanje tekućine i taloga od plazme iz koraka (a) pomoću centrifugiranja; c) dodavanje etanola miješanjem u tekući dio koji pliva na površini stvoren u koraku (b) do konačne koncentracije od oko 5% (v/v) do oko 10% (v/v) etanola, čime se tvori mješavina; d) hlađenje mješavine stvorene u koraku (c) na oko -4°C do oko 0°C; e) odvajanje tekućine i taloga iz mješavine u koraku (d) pomoću centrifugiranja; i izoliranje dijela koji pliva na površini, čime se pripravlja kriosiromašna frakcija plazme.
22. Postupak prema bilo kojem od zahtjeva 13 do 21, naznačen time, da je temperatura smjese iz koraka (b) oko -7°C.
23. Postupak prema bilo kojem od zahtjeva 13 do 22, naznačen time, da se talog stvoren u koraku (c) re-suspendira s oko 12 L do oko 18 L pufera po kg od taloga, poželjno s oko 15 L pufera po kg od taloga.
24. Postupak prema bilo kojem od zahtjeva 13 do 23, naznačen time, da se dodaje silicijev dioksid u koraku (e) u količini između oko 0,02 grama po gramu taloga stvorenog u koraku (c) i oko 0,06 grama po gramu taloga stvorenog u koraku (c).
25. Postupak prema bilo kojem od zahtjeva 13 do 24, naznačen time, da se u smjesu dodaje filter prije koraka filtriranja (f).
26. Postupak prema zahtjevu 25, naznačen time, da pomoćni filter je dijatomejska zemlja.
27. Postupak prema bilo kojem od zahtjeva 13 do 26, naznačen time, da je čistoća γ-globulina u filtratu stvorenom u koraku (f), najmanje oko 85%.
28. Postupak prema bilo kojem od zahtjeva 13 do 27, naznačen time, da filtrat koji je stvoren u koraku (f), sadrži manje od oko 10 mg fibrinogena po gramu ukupnih proteina.
29. Postupak prema bilo kojem od zahtjeva 13 do 28, naznačen time, da filtrat koji je stvoren u koraku (f), sadrži manje od oko 500 IU od PKA-djelotvornosti po gramu ukupnih proteina.
30. Postupak prema bilo kojem od zahtjeva 13 do 29, naznačen time, da deterdžent koji se upotrebljava u koraku (h), sadrži manje oko 0,1% (w/v) do oko 0,3% (w/v) polisorbata-80.
31. Postupak prema bilo kojem od zahtjeva 13 do 30, naznačen time, da vodena otopina koja se upotrebljava u koraku (k), sadrži Triton-X 100, polisorbat-80 i TNBP.
32. Postupak prema bilo kojem od zahtjeva 13 do 31, naznačen time, da se otopina u koraku (k) održava na temperaturi između oko 18°C i oko 25°C.
33. Postupak prema bilo kojem od zahtjeva 13 do 32, naznačen time, da nanofilter u koraku (n) ima veličinu glavnine pora od oko 15 nm do oko 72 nm, poželjno od oko 19 nm do oko 35 nm, najbolje od oko 35 nm.
34. Postupak prema bilo kojem od zahtjeva 13 do 33, naznačen time, da ultrafiltracijska membrana u koraku (o) ima nominalnu molekularnu masu isključka (nominal molecular weight cut off – NMWCO) od oko 100 kDa ili manje.
35. Postupak prema bilo kojem od zahtjeva 13 do 34, naznačen time, da je koncentracija proteina u sastavu od oko 10% (w/v).
36. Postupak prema bilo kojem od zahtjeva 13 do 35, naznačen time, da otopina stvorena u koraku (h) sadrži barem oko 85% poželjno barem oko 90% IgG prisutnog u kriosiromašnoj frakciji plazme iz koraka (a).
HRP20141109AT 2010-05-26 2014-11-14 Postupak za pripravu obogaä†enog sastava igg iz plazme HRP20141109T1 (hr)

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