ME02101B - Pročišćavanje antitijela hromatografijom izmjene katjona - Google Patents

Pročišćavanje antitijela hromatografijom izmjene katjona

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Publication number
ME02101B
ME02101B MEP-2015-34A MEP3415A ME02101B ME 02101 B ME02101 B ME 02101B ME P3415 A MEP3415 A ME P3415A ME 02101 B ME02101 B ME 02101B
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ME
Montenegro
Prior art keywords
cation exchange
antibody
exchange material
washing
buffer
Prior art date
Application number
MEP-2015-34A
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English (en)
Inventor
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=ME02101(B) "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 ME02101B publication Critical patent/ME02101B/me

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    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/08Vasodilators for multiple indications
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/14Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins 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)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (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 (15)

1. Postupak za pročišćavanje antitela iz sastava koji sadrži antitelo i najmanje jedan zagađivač, gde postupak obuhvata sledeće uzastopne korake:a)nanošenje sastava na materijal izmene katjona, gde je sastav na početku na pH od 4,0 do 6,0;b)ispiranje materijala izmene katjona prvim puferom za ispiranje, gde je pH prvog pufera za ispiranje od 6,8 do 9,0;c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; id)eluciju antitela iz materijala izmene katjona puferom za eluciju na provodnosti koja je najmanje 2 mS/cm veća od one kod drugog pufera za ispiranje.
2. Postupak prema patentnom zahtevu 1 gde su pH drugog pufera za ispiranje i pH pufera za eluciju približno isti.
3. Postupak prema patentnom zahtevu 1 gde se antitelo vezuje na humani CD20.
4. Postupak prema patentnom zahtevu 1 gde se antitelo vezuje na humani vaskularni endotelni faktor rasta (VEGF).
5. Postupak prema patentnom zahtevu 1 gde je pH sastava kod (a) od 4,0 do 6,0, pH prvog pufera za ispiranje je od 6,8 do 8,0, pH drugog pufera za ispiranje od 5,0 do 6.0, a pH pufera za eluciju je od 5,0 do 6,0.
6. Postupak prema patentnom zahtevu 1 gde je provodnost pufera za eluciju od 10 mS/cm do 100 mS/cm.
7. Postupak prema patentnom zahtevu 1 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
8. Postupak prema patentnom zahtevu 1, gde materijal izmene katjona sadrži unakrsno spojene poli(stiren-divinilbenzen) protočne čestice obložene polihidroksiliranim polimerom koji je funkcionalizovan sulfopropil grupama.
9. Postupak prema patentnom zahtevu 1 gde je zagađivač odabran iz grupe koja se sastoji od proteina jajnih ćelija kineskog hrčka (CHOP), izlučenog proteina A, DNK, nagomilanih antitela, komponente medijuma ćelijske kulture, garamicina i virusnih zagađenja.
10. Postupak za pročišćavanje antitela koje vezuje humani CD20 iz sastava koji sadrži antitelo i jedan ili više zagađivač odabranih iz skupine koja se sastoji od proteina jajnih ćelija kineskog hrčka (CHOP), ispranog proteina A, DNK, nagomilanoih CD20 antitela, gde postupak obuhvata sledeće uzastopne korake: a)nanošenje sastava na materijal izmene katjona, gde je sastav na pH od 4,0 do 6,0; b)ispiranje materijala izmene katjona prvom puferom za ispiranje na 6,8 do 9,0; c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; i d)eluciju antitela iz materijala izmene katjona puferom za eluciju sa ph od 5,0 do 6,0 i provodnosti od 10 mS/cm do 100 mS/cm.
11. Postupak prema patentnom zahtevu 10 gde je antitelo rituksimab.
12. Postupak prema patentnom zahtevu 10 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
13. Postupak za pročišćavanje antitela koje vezuje humani vaskularni endotelni faktor rasta (VEGF) iz sastava koji sadrži antitelo i jedan ili više zagađivača odabranih iz grupe koja se sastoji od komponente medijuma ćelijske kulture, garamicina, proteina jajnih ćelija kineskog hrčka (CHOPS) DNK, virusnih zagađivača i nagomilanih VEGF antitela, gde postupak obuhvata sledeće uzastopne korake: a)nanošenje sastava na materijal izmene katjona, gde je sastav na pH od 4,0 do 6,0; b)ispiranje materijala izmene katjona prvom puferom za ispiranje na 6,8 do 8,0; c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; i d)eluciju antitela iz materijala izmene katjona puferom za eluciju sa ph od 5,0 do 6,0 i provodnosti od 10 mS/cm do 100 mS/cm.
14. Postupak prema patentnom zahtevu 13 gde je antitelo bevacizumab.
15. Postupak prema patentnom zahtevu 13 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
MEP-2015-34A 2007-10-30 2008-10-29 Pročišćavanje antitijela hromatografijom izmjene katjona ME02101B (me)

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 (1)

Publication Number Publication Date
ME02101B true ME02101B (me) 2015-10-20

Family

ID=40262967

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2015-34A ME02101B (me) 2007-10-30 2008-10-29 Pročišćavanje antitijela hromatografijom izmjene katjona

Country Status (32)

Country Link
US (3) US20090148435A1 (me)
EP (4) EP2565206B1 (me)
JP (5) JP5237382B2 (me)
KR (3) KR101241486B1 (me)
CN (3) CN101889025B (me)
AR (2) AR069097A1 (me)
AU (1) AU2008318865B2 (me)
BR (1) BRPI0817182A2 (me)
CA (1) CA2703279C (me)
CL (1) CL2008003218A1 (me)
CO (1) CO6280422A2 (me)
CY (1) CY1116129T1 (me)
DK (3) DK2840090T3 (me)
ES (3) ES2666170T3 (me)
HK (1) HK1221234A1 (me)
HR (2) HRP20150282T4 (me)
HU (3) HUE024877T2 (me)
IL (4) IL205310A0 (me)
ME (1) ME02101B (me)
MX (1) MX2010004740A (me)
NZ (1) NZ584839A (me)
PE (1) PE20091434A1 (me)
PH (1) PH12013501128A1 (me)
PL (3) PL2215117T5 (me)
PT (1) PT2215117E (me)
RS (1) RS53850B2 (me)
RU (1) RU2498991C2 (me)
SG (2) SG10201401690XA (me)
SI (3) SI2565206T1 (me)
TW (2) TWI554517B (me)
WO (1) WO2009058812A1 (me)
ZA (2) ZA201002850B (me)

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RU2010121816A (ru) 2011-12-10
SI2840090T1 (en) 2018-05-31
US9896478B2 (en) 2018-02-20

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