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DK1501369T3 - Ikke-affinitetsoprensning af proteiner - Google Patents

Ikke-affinitetsoprensning af proteiner Download PDF

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Publication number
DK1501369T3
DK1501369T3 DK03756162.8T DK03756162T DK1501369T3 DK 1501369 T3 DK1501369 T3 DK 1501369T3 DK 03756162 T DK03756162 T DK 03756162T DK 1501369 T3 DK1501369 T3 DK 1501369T3
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DK
Denmark
Prior art keywords
protein
antibody
antibodies
proteins
ser
Prior art date
Application number
DK03756162.8T
Other languages
English (en)
Inventor
Robert Lee Fahner
Benedicte Lebreton
Deborah Follman
Robert Van Reis
Original Assignee
Genentech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=29711917&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1501369(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Application granted granted Critical
Publication of DK1501369T3 publication Critical patent/DK1501369T3/da

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K1/18—Ion-exchange chromatography
    • 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
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
    • 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
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2845—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Peptides Or Proteins (AREA)

Claims (22)

1. Fremgangsmåde til oprensning af et målprotein fra en blanding, der indeholder et værtscelleprotein, omfattende at udsætte blandingen for: (a) et første ikke-affinitetsoprensningstrin og (b) et andet ikke-affinitetsoprensningstrin efterfulgt af (c) HPTFF (high-performance tangential flow filtration) og (d) isolering af proteinet til en renhed, der indeholder mindre end 100 ppm (parts per million) af værtscelleproteinet, hvor det første ikke-affinitetsoprensningstrin er kationudvekslingskromatogra-fi, og det andet ikke-affinitetsoprensningstrin er anionudvekslingskromatogra-fi, og hvor fremgangsmåden ikke omfatter noget affinitetsoprensningstrin.
2. Fremgangsmåde ifølge krav 1, hvor kationudvekslingskromatografitrinnet udføres på en kationudvekslingsligand, der er valgt fra gruppen bestående af carboxymethyl, sulphopropyl (SP) og sulphonyl.
3. Fremgangsmåde ifølge krav 1, hvor kationudvekslingskromatografitrinnet udføres på en kationudvekslingsresin, der er valgt fra gruppen bestående af carboxy-methyl-cellulose, sulphopropyl immobiliseret på agarose og sulphonyl immobiliseret på agarose.
4. Fremgangsmåde ifølge krav 1, hvor anionudvekslingskromatografitrinnet udføres på en anionudvekslingsligand, der er valgt fra gruppen bestående af DEAE og kvaternære ammoniumioner.
5. Fremgangsmåde ifølge krav 1, hvor anionudvekslingskromatografitrinnet udføres på en anionudvekslingsresin, der er valgt fra gruppen bestående af DEAE-cellulose, QAE SEPHADEX™ og Q SEPHAROSE™.
6. Fremgangsmåde ifølge krav 1, hvor HPTFF udføres ved anvendelse af en ladet membran.
7. Fremgangsmåde ifølge krav 1, hvor værtscelleproteinet er CHOP (Chinese Hamster Ovary Protein).
8. Fremgangsmåde ifølge krav 1, hvor målproteinet er et antistof.
9. Fremgangsmåde ifølge krav 8, hvor antistoffet er et monoklonalt antistof.
10. Fremgangsmåde ifølge krav 8, hvor antistoffet er et polyklonalt antistof.
11. Fremgangsmåde ifølge krav 8, hvor antistoffet er et humaniseret antistof.
12. Fremgangsmåde ifølge krav 8, hvor antistoffet er et humant antistof.
13. Fremgangsmåde ifølge krav 8, hvor antistoffet er et antistoffragment.
14. Fremgangsmåde ifølge krav 13, hvor antistoffragmentet vælges fra gruppen bestående af Fab-, Fab'-, F(ab')2- og Fv-fragmenter, enkeltkædede antistofmolekyler, diabodies, lineære antistoffer, bispecifikke antistoffer og mul-tispecifikke antistoffer, der er dannet ud fra antistoffragmenter.
15. Fremgangsmåde ifølge krav 8, hvor antistoffet specifikt binder til et antigen, der er valgt fra gruppen bestående af CD3, CD4, CD8, CD19, CD20, CD34, CD40, EGF-receptor, FIER2, FIER3, FIER4-receptor, LFA-1, Mad, p150,95, VLA-4, ICAM-1, VCAM, av/33-integrin, CD11a, CD18, CDIIb, VEGF, IgE, flk2/flt3-receptor, OB (obesity)-receptor, mp/-receptor, CTLA-4 og polypeptid C.
16. Fremgangsmåde ifølge krav 8, hvor antistoffet vælges fra gruppen bestående af anti-FIER2; anti-CD20; anti-IL-8; anti-VEGF; anti-PSCA; anti-CD11a; anti-lgE; anti-Apo-2-receptor; anti-TNF-α; anti-TF (Tissue Factor); anti-CD3; anti-CD25; anti-CD34; anti-CD40; anti-tac; anti-CD4; anti-CD52; anti-Fc-receptor; anti-carcinoembryonantigen (CEA)-antistoffer; antistoffer rettet mod brystepitelceller; antistoffer, der binder til kolonkarcinomceller; anti-CD33; anti-CD22; anti-EpCAM; anti-Gpllb/llla; anti-RSV; anti-CMV; anti-HIV; anti-hepatitis; anti-av33; anti-humant nyrecellekarcinom; anti-human-17-1A; anti-human kolorektal tumor; anti-humant melanom; anti-humant pladecellekarci-nom; og anti-humant leukocytantigen (HLA)-antistoffer.
17. Fremgangsmåde ifølge krav 8, hvor antistoffet vælges fra gruppen bestående af anti-HER2-receptor, anti-VEGF, anti-lgE, anti-CD20, anti-CD11a og anti-CD40-antistoffer.
18. Fremgangsmåde ifølge krav 1, hvor målproteinet er et immunoadhesin.
19. Fremgangsmåde ifølge krav 1, hvor målproteinet er et antistof-lignende molekyle.
20. Fremgangsmåde ifølge krav 19, hvor det antistof-lignende molekyle er et protein, der er fusioneret eller konjugeret med en CH2/CH3-region.
21. Fremgangsmåde ifølge krav 20, hvor proteinet vælges fra gruppen bestående af renin; væksthormoner; væksthormonfrigivende faktor; parathyreo-ideahormon; skjoldbruskkirtelstimulerende hormon; lipoproteiner; alpha-1-antitrypsin; insulin-A-kæde; insulin-B-kæde; proinsulin; follikelstimulerende hormon; calcitonin; luteiniserende hormon; glucagon; faktor VIIIC; faktor IX; vævsfaktor; von Willebrand-faktor; protein C; aterienatriuretisk faktor; lunge-overfladeaktivt stof; urokinase; human urin- og vævstypeplasminogen aktivator (t-PA); bombesin; thrombin; hæmopoietisk vækstfaktor; tumornekrosefak-tor-alpha og -beta; enkephalinase; RANTES; humant makrofaginflammato-risk protein (MIP-1 -alpha); serumalbuminer; Muellerian-inhiberende substans; relaxin-A-kæde; relaxin-B-kæde; prorelaxin; musegonadotropin-associeret peptid; beta-lactamase; DNase; IgE; cytotoksisk T-lymfocyt-associeret antigener (CTLAs); inhibin; activin; VEGF (vascular endothelial growth factor); receptorer for hormoner eller vækstfaktorer; protein A eller D; rheumatoide faktorer; BDNF (bone-derived neurotrophic factor); neurotrop-hin-3,-4, -5 og -6 (NT-3, NT- 4, NT-5 og NT-6), nervevækstf akto rer; PDGF (platelet-derived growth factor); fibroblastvækstfaktorer; EGF (epidermal growth factor); TGF (transforming growth factors); insulin-lignende vækstfak-tor-l og -II (IGF-I og IGF-II); des(1-3)-IGF-l (hjerne-IGF-l), insulin-lignende vækstfaktorbindende proteiner (IGFBPs); CD-proteiner; erythropoietin; osteo-induktive faktorer; immunotoksiner; BMPs (bone morphogenetic proteins); interferon-alpha, -beta og -gamma; CSFs (colony stimulating factors); interleukin IL-1 til IL-10; superoxiddismutase; T-celle-receptorer; overflademem-branproteiner; nedbrydningsaccelerende faktor; virale antigener; transport proteiner; homing-receptorer; addressiner; regulerende proteiner; integriner; tumorassocierede antigener og fragmenter deraf.
22. Fremgangsmåde ifølge krav 1, endvidere omfattende trinnene med at inkorporere det isolerede protein i en farmaceutisk form.
DK03756162.8T 2002-04-26 2003-04-25 Ikke-affinitetsoprensning af proteiner DK1501369T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37595302P 2002-04-26 2002-04-26
PCT/US2003/013054 WO2003102132A2 (en) 2002-04-26 2003-04-25 Non-affinity purification of proteins

Publications (1)

Publication Number Publication Date
DK1501369T3 true DK1501369T3 (da) 2015-09-28

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Family Applications (1)

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Country Status (12)

Country Link
US (2) US7323553B2 (da)
EP (1) EP1501369B1 (da)
JP (1) JP4319979B2 (da)
KR (1) KR100788093B1 (da)
AU (1) AU2003265235A1 (da)
CA (1) CA2478925C (da)
DK (1) DK1501369T3 (da)
ES (1) ES2545067T3 (da)
HU (1) HUE025101T2 (da)
PT (1) PT1501369E (da)
SI (1) SI1501369T1 (da)
WO (1) WO2003102132A2 (da)

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