HRP20191905T1 - Sprečavanje redukcije disulfidne veze za vrijeme rekombinantne proizvodnje polipeptida - Google Patents
Sprečavanje redukcije disulfidne veze za vrijeme rekombinantne proizvodnje polipeptida Download PDFInfo
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- HRP20191905T1 HRP20191905T1 HRP20191905TT HRP20191905T HRP20191905T1 HR P20191905 T1 HRP20191905 T1 HR P20191905T1 HR P20191905T T HRP20191905T T HR P20191905TT HR P20191905 T HRP20191905 T HR P20191905T HR P20191905 T1 HRP20191905 T1 HR P20191905T1
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- 229920001184 polypeptide Polymers 0.000 title 1
- 230000002265 prevention Effects 0.000 title 1
- 102000004196 processed proteins & peptides Human genes 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 title 1
- 238000000034 method Methods 0.000 claims 14
- 239000012930 cell culture fluid Substances 0.000 claims 9
- 238000007664 blowing Methods 0.000 claims 7
- 102100022005 B-lymphocyte antigen CD20 Human genes 0.000 claims 3
- 101000897405 Homo sapiens B-lymphocyte antigen CD20 Proteins 0.000 claims 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 2
- 238000000855 fermentation Methods 0.000 claims 2
- 230000004151 fermentation Effects 0.000 claims 2
- 229910052760 oxygen Inorganic materials 0.000 claims 2
- 239000001301 oxygen Substances 0.000 claims 2
- 229920006395 saturated elastomer Polymers 0.000 claims 2
- 241000699802 Cricetulus griseus Species 0.000 claims 1
- 229950005751 ocrelizumab Drugs 0.000 claims 1
- 210000001672 ovary Anatomy 0.000 claims 1
- 229960004641 rituximab Drugs 0.000 claims 1
- 229940126622 therapeutic monoclonal antibody Drugs 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
- C12N1/38—Chemical stimulation of growth or activity by addition of chemical compounds which are not essential growth factors; Stimulation of growth by removal of a chemical compound
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
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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
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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
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
-
- 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
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, 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
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/0018—Culture media for cell or tissue culture
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
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- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Analytical Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- General Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Tropical Medicine & Parasitology (AREA)
- Virology (AREA)
- Oncology (AREA)
- Cell Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (12)
1. Postupak za sprečavanje redukcije disulfidne veze u protutijelu koji se eksprimira u rekombinantnoj stanici domaćina, naznačen time, da se provodi za vrijeme prerade koja slijedi nakon izvođenja fermentacije, te nakon izvođenja fermentacije, obuhvaća propuhivanje zrakom fluida stanične kulture iz rekombinantne stanice domaćina, prije njegovog dobivanja ili nakon dobivanja prilikom njegovog sakupljanja,
pri čemu rekombinantna stanica domaćina je rekombinantna stanica domaćina jajnika kineskog hrčka (CHO) i pritom, protutijelo koje je eksprimirano u rekombinantnoj stanici domaćina je terapeutsko monoklonsko protutijelo koje se veže na CD20.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da postupak obuhvaća propuhivanje zrakom fluida stanične kulture prije njegovog dobivanja.
3. Postupak prema patentnom zahtjevu 1, naznačen time, da postupak obuhvaća propuhivanje zrakom sakupljenog fluida stanične kulture nakon njegovog dobivanja.
4. Postupak prema patentnom zahtjevu 3, naznačen time, da se propuhivanje zrakom nastavlja sve dok sakupljeni fluid stanične kulture ne bude zasićen zrakom najmanje 30%.
5. Postupak prema patentnom zahtjevu 3 ili zahtjevu 4, naznačen time, da se propuhivanje zrakom nastavlja sve dok sakupljeni fluid stanične kulture ne bude zasićen zrakom između 100% i 30%.
6. Postupak prema patentnom zahtjevu 3, naznačen time, da se propuhivanje zrakom nastavlja sve dok količina otopljenog kisika (dO2) u sakupljenom fluidu stanične kulture ne bude najmanje 10%.
7. Postupak prema patentnom zahtjevu 3, naznačen time, da se propuhivanje zrakom nastavlja sve dok količina otopljenog kisika (dO2) u sakupljenom fluidu stanične kulture ne bude najmanje 30%.
8. Postupak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da protutijelo koje se veže na CD20 je rituksimab.
9. Postupak prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da protutijelo koje se veže na CD20 je okrelizumab.
10. Postupak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da se protutijelo koje se eksprimira u rekombinantnoj stanici domaćina, proizvodi u količini većoj od 5000 L.
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da dodatno sadrži korak dobivanja protutijela iz sakupljenog fluida stanične kulture.
12. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da dodatno sadrži korak pročišćavanja protutijela iz sakupljenog fluida stanične kulture.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US94867707P | 2007-07-09 | 2007-07-09 | |
EP17196350.7A EP3327026B1 (en) | 2007-07-09 | 2008-07-08 | Prevention of disulfide bond reduction during recombinant production of polypeptides |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20191905T1 true HRP20191905T1 (hr) | 2020-01-24 |
Family
ID=39791340
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230461TT HRP20230461T3 (hr) | 2007-07-09 | 2008-07-08 | Prevencija redukcije disulfidne veze tijekom rekombinantne proizvodnje polipeptida |
HRP20180673TT HRP20180673T1 (hr) | 2007-07-09 | 2018-04-26 | Sprečavanje redukcije disulfidne veze za vrijeme rekombinantne proizvodnje polipeptida |
HRP20191905TT HRP20191905T1 (hr) | 2007-07-09 | 2019-10-21 | Sprečavanje redukcije disulfidne veze za vrijeme rekombinantne proizvodnje polipeptida |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230461TT HRP20230461T3 (hr) | 2007-07-09 | 2008-07-08 | Prevencija redukcije disulfidne veze tijekom rekombinantne proizvodnje polipeptida |
HRP20180673TT HRP20180673T1 (hr) | 2007-07-09 | 2018-04-26 | Sprečavanje redukcije disulfidne veze za vrijeme rekombinantne proizvodnje polipeptida |
Country Status (24)
Country | Link |
---|---|
US (14) | US20090053786A1 (hr) |
EP (8) | EP4245766A3 (hr) |
JP (5) | JP5687057B2 (hr) |
KR (6) | KR101643514B1 (hr) |
CN (3) | CN101932591B (hr) |
AU (2) | AU2008275229B2 (hr) |
BR (1) | BRPI0812603B1 (hr) |
CA (2) | CA2691692C (hr) |
DE (1) | DE17196350T1 (hr) |
DK (2) | DK3597659T3 (hr) |
ES (4) | ES2659829T3 (hr) |
FI (1) | FI3597659T3 (hr) |
HR (3) | HRP20230461T3 (hr) |
HU (4) | HUE061746T2 (hr) |
IL (6) | IL202934B (hr) |
LT (2) | LT3327026T (hr) |
MX (2) | MX2010000196A (hr) |
PL (4) | PL3327026T3 (hr) |
PT (2) | PT3327026T (hr) |
SG (3) | SG10201406411XA (hr) |
SI (4) | SI3327026T1 (hr) |
TR (1) | TR201802088T4 (hr) |
TW (4) | TWI702225B (hr) |
WO (1) | WO2009009523A2 (hr) |
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