SI2590998T1 - Metoda za pripravo rekombinantnega von Willerbrandovega faktorja z visoko molekulsko maso v celični kulturi - Google Patents

Metoda za pripravo rekombinantnega von Willerbrandovega faktorja z visoko molekulsko maso v celični kulturi Download PDF

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SI2590998T1
SI2590998T1 SI201131409T SI201131409T SI2590998T1 SI 2590998 T1 SI2590998 T1 SI 2590998T1 SI 201131409 T SI201131409 T SI 201131409T SI 201131409 T SI201131409 T SI 201131409T SI 2590998 T1 SI2590998 T1 SI 2590998T1
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rvwf
cells
cell culture
supernatant
copper
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Leopold Grillberger
Manfred Reiter
Wolfgang Mundt
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Baxalta GmbH
Baxalta Incorporated
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Application filed by Baxalta GmbH, Baxalta Incorporated filed Critical Baxalta GmbH
Publication of SI2590998T1 publication Critical patent/SI2590998T1/sl

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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
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    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61P33/00—Antiparasitic agents
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    • A61P33/06—Antimalarials
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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    • 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
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C—CHEMISTRY; METALLURGY
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    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
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    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6489—Metalloendopeptidases (3.4.24)
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    • C12P21/00—Preparation of peptides or proteins
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    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)

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Claims (17)

  1. Metoda za pripravo rekombinantnega von VVillerbrandovega faktorja z visoko molekulsko maso v celični kulturi PATENTNI ZAHTEVKI
    1. Metoda za pripravo rekombinantnega sestavka Von VVillebrandovega faktorja (rVWF), metoda obsega korake: (a) zagotovitev medija bazalne celične kulture; (b) dopolnjevanje medija bazalne celične kulture z bakrom, da se zagotovi končna koncentracija bakra med 2,4 pg/L in 20 pg/L bakra; (c) zagotavljanje ene ali več celic, ki obsega nukleinsko kislino, ki kodira protein rVWF; (d) kultiviranje ene ali več celic v medijih celične kulture, dopolnjenem z bakrom, tako da se izrazi rVWF in izloči iz celic v supernatant kulture, kjer se vsebnost NH4+ supernatanta celične kulture vzdržuje pri koncentraciji pod 4 mM; in (e) rekuperiranje vsaj dela supernatanta kulture, kjer ima rekuperiran supernatant aktivnost rVWF specifičnega ristocetin kofaktorja najmanj 30 mU/pg rVWF.
  2. 2. Metoda po zahtevku 1, nadalje obsega korak dopolnjevanja medija bazalne celične kulture s hidrolizatom pred kultiviranjem ene ali več celic.
  3. 3. Metoda po zahtevku 2, kjer je hidrolizat rastlinski hidrolizat ali sojin hidrolizat.
  4. 4. Metoda po katerem koli od 1 do 3, kjer je medij bazalne celične kulture medij kulture brez živalskih proteinov, medij kulture brez proteinov ali kemično definiran medij kulture.
  5. 5. Metoda po katerem koli od 1 to 4, kjer je končna koncentracija bakra medija bazalne celične kulture dopolnjenega z bakrom vsaj 4 pg/L bakra.
  6. 6. Metoda po katerem koli od 1 do 5, kjer je ena ali več celic celic sesalca, prednostno CHO celic.
  7. 7. Metoda po katerem koli od 1 do 6, kjer kultiviranje ene ali več celic obsega šaržno kultivacijo celic ali obsega kontinuimo gojenje celic.
  8. 8. Metoda po zahtevku 7, kjer se kontinuima kultivacija celic izvaja v kemostatičnem načinu ali v perfuzijskem načinu.
  9. 9. Metoda po katerem koli od zahtevkov 1 do 8, kjer je ena ali več celic kultivirana v vsaj 100 L medija dopolnjene bazalne celične kulture.
  10. 10. Metoda po katerem koli od zahtevkov 1 do 9, kjer se gostoto celic vzdržuje pri manj kot 2,5 x 106 celic na ml_ med korakom gojitve ene ali več celic, manj kot 2,0 x 106 celic na mL med korakom gojenja ene ali več celic ali manj kot 1,5x10® celic na mL med korakovom gojenja ene ali več celic.
  11. 11. Metoda po katerem koli od zahtevkov 1 do 10, kjer korak rekuperiranja vsaj enega dela kulture supernatanta obsega filtracijo ali centrifugiranje, da odstranimo celice iz dela supernatanta kulture.
  12. 12. Metoda po katerem koli od zahtevkov 1 do 11, kjer ima rekuperiran supernatant rVWF specifično ristocetin kofaktorsko aktivnost najmanj 40 mU/pg rVWF.
  13. 13. Metoda po zahtevku 12, kjer ima rekuperirani supernatant rVWF specifično ristocetin kofaktorsko aktivnost pri najmanj 50 mll/pg rVWF, najmanj 60 mll/pg rVWF, vsaj 70 mll/pg rVWF ali najmanj 80 mll/pg rVWF.
  14. 14. Metoda po katerem koli od zahtevkov 1-13, kjer je vsaj 10%, 20% ali 30% rVWF v supematantu prisotenega v visoko molekulami masi VWF multimera z več kot 10 dimeri.
  15. 15. Metoda po katerem koli od zahtevkov 1-14, kjer supernatant vsebuje VWF multimere z visoko molekulsko maso od 14 do 22 dimerov.
  16. 16. Metoda po katerem koli od zahtevkov 1 do 15, kjer je rVWF so-izražen z rekombinantnim faktorjem Vlil (rFVIII).
  17. 17. Metoda po katerem koli od zahtevkov 1-16, kjer metoda nadalje obsega korak obogatitve rVWF.
SI201131409T 2010-07-08 2011-07-08 Metoda za pripravo rekombinantnega von Willerbrandovega faktorja z visoko molekulsko maso v celični kulturi SI2590998T1 (sl)

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Application Number Priority Date Filing Date Title
US36263510P 2010-07-08 2010-07-08
PCT/US2011/043455 WO2012006591A1 (en) 2010-07-08 2011-07-08 METHOD OF PRODUCING RECOMBINANT HIGH MOLECULAR WEIGHT vWF IN CELL CULTURE
EP11736502.3A EP2590998B1 (en) 2010-07-08 2011-07-08 METHOD OF PRODUCING RECOMBINANT HIGH MOLECULAR WEIGHT vWF IN CELL CULTURE

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SI201131603T SI2591094T1 (sl) 2010-07-08 2011-07-08 Metoda proizvodnje rekombinantnih ADAMTS13 v celični kulturi
SI201131818T SI3064508T2 (sl) 2010-07-08 2011-07-08 Metoda za pripravo rekombinantnih VWF z visoko molekularno maso v celični kulturi
SI201131409T SI2590998T1 (sl) 2010-07-08 2011-07-08 Metoda za pripravo rekombinantnega von Willerbrandovega faktorja z visoko molekulsko maso v celični kulturi

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SI201131603T SI2591094T1 (sl) 2010-07-08 2011-07-08 Metoda proizvodnje rekombinantnih ADAMTS13 v celični kulturi
SI201131818T SI3064508T2 (sl) 2010-07-08 2011-07-08 Metoda za pripravo rekombinantnih VWF z visoko molekularno maso v celični kulturi

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US (8) US9458222B2 (sl)
EP (6) EP2590998B1 (sl)
JP (3) JP6138683B2 (sl)
KR (4) KR102027991B1 (sl)
CN (4) CN103097409A (sl)
AU (6) AU2011274467B2 (sl)
BR (2) BR112013000512A2 (sl)
CA (2) CA2804275A1 (sl)
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PT (3) PT2590998T (sl)
SG (3) SG10201809632XA (sl)
SI (3) SI2591094T1 (sl)
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