SI2215117T2 - Čiščenje protitelesa s kationsko izmenjevalno kromatografijo - Google Patents

Čiščenje protitelesa s kationsko izmenjevalno kromatografijo Download PDF

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SI2215117T2
SI2215117T2 SI200831381T SI200831381T SI2215117T2 SI 2215117 T2 SI2215117 T2 SI 2215117T2 SI 200831381 T SI200831381 T SI 200831381T SI 200831381 T SI200831381 T SI 200831381T SI 2215117 T2 SI2215117 T2 SI 2215117T2
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antibody
buffer
exchange material
spiral
composition
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SI200831381T
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SI2215117T1 (sl
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Benedicte Andree Lebreton
Deborah Ann O'connor
Aurelia Safta
Mandakini Sharma
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Genentech, Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40262967&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI2215117(T2) "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.
Publication of SI2215117T1 publication Critical patent/SI2215117T1/sl
Publication of SI2215117T2 publication Critical patent/SI2215117T2/sl

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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
    • C07K1/18—Ion-exchange chromatography
    • 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
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • 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
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
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  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
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  • Engineering & Computer Science (AREA)
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  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
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  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Vascular Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)

Claims (9)

  1. Čiščenje protitelesa s kationsko izmenjevalno kromatografijo Patentni zahtevki
    1. Postopek za čiščenje protitelesa iz sestavka, ki obsega protitelo in vsaj en kontaminant, pri čemer postopek obsega zaporedne stopnje: (a) nalaganje sestavka na kationski izmenjevalni material, kjer je sestavek najprej pri pH od 4,0 do 6,0; (b) spiranje kationskega izmenjevalnega materiala s prvim spiralnim pufrom, kjer je pH prvega spiralnega pufra od 6,8 do 9,0; (c) spiranje kationskega izmenjevalnega materiala z drugim spiralnim pufrom pri pH od 5,0 do 6,0; in (d) eluiranje protitelesa iz kationskega izmenjevalnega materiala z elucijskim pufrom pri prevodnosti, ki je vsaj 2 mS/cm večja od tiste, ki jo ima drugi spiralni pufer, kjer je protitelo bevacizumab.
  2. 2. Postopek po zahtevku 1, kjer sta pH drugega spiralnega pufra in pH elucijskega pufra približno enaka.
  3. 3. Postopek po zahtevku 1, kjer je pH sestavka v (a) od 4,0 do 6,0, je pH prvega spiralnega pufra od 6,8 do 8,0, je pH drugega spiralnega pufra od 5,0 do 6,0 in je pH elucijskega pufra od 5,0 do 6,0.
  4. 4. Postopek po zahtevku 1, kjer je prevodnost elucijskega pufra od 10 mS/cm do 100 mS/cm.
  5. 5. Postopek po zahtevku 1, kjer elucijski pufer obsega od 100 mM do 300 mM NaCl.
  6. 6. Postopek po zahtevku 1, kjer kationski izmenjevalni material obsega pretočne delce zamreženega poli(stiren-divinilbenzena), obložene s polihidroksiliranim polimerom, funkcionaliziranim s sulfopropilnimi skupinami.
  7. 7. Postopek po zahtevku 1, kjer je kontaminant izbran iz skupine, ki jo sestavljajo proteini ovarija kitajskega hrčka (CHOP, "Chinese Hamster Ovary Proteins"), izlužen protein A, DNA, agregirano protitelo, komponenta celičnega gojitvenega medija, garamicin in virusni kontaminant.
  8. 8. Postopek za čiščenje protitelesa, ki veže humani vaskulami endotelijski rastni faktor (VEGF), iz sestavka, ki obsega protitelo in en ali več kontaminantov, izbranih iz skupine, ki jo sestavljajo komponenta celičnega gojitvenega medija, garamicin, proteini ovarija kitajskega hrčka (CHOP), DNA, virusni kontaminant in agregirano VEGF protitelo, pri čemer postopek obsega zaporedne stopnje: (a) nalaganje sestavka na kationski izmenjevalni material, kjer je sestavek pri pH od 4,0 do 6,0; (b) spiranje kationskega izmenjevalnega materiala s prvim spiralnim pufrom pri pH od 6,8 do 8,0; (c) spiranje kationskega izmenjevalnega materiala z drugim spiralnim pufrom pri pH od 5,0 do 6,0; in (d) eluiranje protitelesa iz kationskega izmenjevalnega materiala z uporabo elucijskega pufra s pH od 5,0 do 6,0 in prevodnostjo od 10 mS/cm do 100 mS/cm, kjer je protitelo bevacizumab.
  9. 9. Postopek po zahtevku 13, kjer elucijski pufer obsega od 100 mM do 300 mM NaCl.
SI200831381T 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo SI2215117T2 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US98382507P 2007-10-30 2007-10-30
PCT/US2008/081516 WO2009058812A1 (en) 2007-10-30 2008-10-29 Antibody purification by cation exchange chromatography
EP08844379.1A EP2215117B2 (en) 2007-10-30 2008-10-29 Antibody purification by cation exchange chromatography

Publications (2)

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SI2215117T1 SI2215117T1 (sl) 2015-03-31
SI2215117T2 true SI2215117T2 (sl) 2018-04-30

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SI200831634A SI2565206T1 (sl) 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo
SI200831945T SI2840090T1 (sl) 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo
SI200831381T SI2215117T2 (sl) 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo

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SI200831634A SI2565206T1 (sl) 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo
SI200831945T SI2840090T1 (sl) 2007-10-30 2008-10-29 Čiščenje protitelesa s kationsko izmenjevalno kromatografijo

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US (3) US20090148435A1 (sl)
EP (4) EP2215117B2 (sl)
JP (5) JP5237382B2 (sl)
KR (3) KR20140015166A (sl)
CN (3) CN101889025B (sl)
AR (2) AR069097A1 (sl)
AU (1) AU2008318865B2 (sl)
BR (1) BRPI0817182A2 (sl)
CA (1) CA2703279C (sl)
CL (1) CL2008003218A1 (sl)
CO (1) CO6280422A2 (sl)
CY (1) CY1116129T1 (sl)
DK (3) DK2840090T3 (sl)
ES (3) ES2666170T3 (sl)
HK (4) HK1182401A1 (sl)
HR (2) HRP20150282T4 (sl)
HU (3) HUE027668T2 (sl)
IL (4) IL205310A0 (sl)
ME (1) ME02101B (sl)
MX (1) MX2010004740A (sl)
NZ (1) NZ584839A (sl)
PE (1) PE20091434A1 (sl)
PH (1) PH12013501128A1 (sl)
PL (3) PL2215117T5 (sl)
PT (1) PT2215117E (sl)
RS (1) RS53850B2 (sl)
RU (1) RU2498991C2 (sl)
SG (2) SG10201401690XA (sl)
SI (3) SI2565206T1 (sl)
TW (2) TWI554517B (sl)
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ZA (2) ZA201002850B (sl)

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