WO2003046162A3 - Process for the production of polypeptides in mammalian cell cultures - Google Patents

Process for the production of polypeptides in mammalian cell cultures Download PDF

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Publication number
WO2003046162A3
WO2003046162A3 PCT/EP2002/013431 EP0213431W WO03046162A3 WO 2003046162 A3 WO2003046162 A3 WO 2003046162A3 EP 0213431 W EP0213431 W EP 0213431W WO 03046162 A3 WO03046162 A3 WO 03046162A3
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WO
WIPO (PCT)
Prior art keywords
polypeptide
interest
host cell
transformed host
culture medium
Prior art date
Application number
PCT/EP2002/013431
Other languages
French (fr)
Other versions
WO2003046162A2 (en
Inventor
Hermann Katinger
Renate Kunert
Dethardt Mueller
Florian Unterluggauer
Original Assignee
Polymun Scient Immunbio Forsch
Hermann Katinger
Renate Kunert
Dethardt Mueller
Florian Unterluggauer
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.)
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Publication date
Application filed by Polymun Scient Immunbio Forsch, Hermann Katinger, Renate Kunert, Dethardt Mueller, Florian Unterluggauer filed Critical Polymun Scient Immunbio Forsch
Priority to AU2002356749A priority Critical patent/AU2002356749A1/en
Publication of WO2003046162A2 publication Critical patent/WO2003046162A2/en
Publication of WO2003046162A3 publication Critical patent/WO2003046162A3/en

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/87Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/90Stable introduction of foreign DNA into chromosome
    • C12N15/902Stable introduction of foreign DNA into chromosome using homologous recombination
    • C12N15/907Stable introduction of foreign DNA into chromosome using homologous recombination in mammalian cells
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/505Erythropoietin [EPO]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/87Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/90Stable introduction of foreign DNA into chromosome
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • C12P21/02Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2500/00Specific components of cell culture medium
    • C12N2500/30Organic components
    • C12N2500/34Sugars
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2500/00Specific components of cell culture medium
    • C12N2500/70Undefined extracts
    • C12N2500/76Undefined extracts from plants
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2500/00Specific components of cell culture medium
    • C12N2500/90Serum-free medium, which may still contain naturally-sourced components
    • C12N2500/95Protein-free medium and culture conditions
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2510/00Genetically modified cells
    • C12N2510/02Cells for production
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2840/00Vectors comprising a special translation-regulating system
    • C12N2840/20Vectors comprising a special translation-regulating system translation of more than one cistron
    • C12N2840/203Vectors comprising a special translation-regulating system translation of more than one cistron having an IRES

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Chemistry (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

The invention provides a method for producing a polypeptide of interest which method comprises: providing a transformed host cell which comprises a nucleotide sequence which encodes a polypeptide of interest and which directs expression of the polypeptide of interest in the transformed host cell, or a hybridoma which comprises a nucleotide sequence encoding a polypeptide of interest; providing a culture medium suitable for mammalian cell culture; and culturing the hybridoma or transformed host cell in the culture medium under conditions that allow for expression of the polypeptide of interest, wherein the culture medium (i) comprises water, a buffer, an energy source, amino acids, a lipid source or precursor, a source of iron, non-ferrous metal ions, inorganic salts, vitamins and cofactors; and (ii) is free from each of a plant-derived or animal-derived peptone, a functional protein, and a full-length polypeptide. The invention further relates to a transformed host cell and to suitable low-cost media applicable in the method of the present invention.
PCT/EP2002/013431 2001-11-28 2002-11-28 Process for the production of polypeptides in mammalian cell cultures WO2003046162A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002356749A AU2002356749A1 (en) 2001-11-28 2002-11-28 Process for the production of polypeptides in mammalian cell cultures

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US33386801P 2001-11-28 2001-11-28
US33386701P 2001-11-28 2001-11-28
US60/333,867 2001-11-28
US60/333,868 2001-11-28

Publications (2)

Publication Number Publication Date
WO2003046162A2 WO2003046162A2 (en) 2003-06-05
WO2003046162A3 true WO2003046162A3 (en) 2003-10-16

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PCT/EP2002/013431 WO2003046162A2 (en) 2001-11-28 2002-11-28 Process for the production of polypeptides in mammalian cell cultures

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AU (1) AU2002356749A1 (en)
WO (1) WO2003046162A2 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
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US9290568B2 (en) 2012-09-02 2016-03-22 Abbvie, Inc. Methods to control protein heterogeneity
US9359434B2 (en) 2012-04-20 2016-06-07 Abbvie, Inc. Cell culture methods to reduce acidic species
US9365645B1 (en) 2011-04-27 2016-06-14 Abbvie, Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US9499616B2 (en) 2013-10-18 2016-11-22 Abbvie Inc. Modulated lysine variant species compositions and methods for producing and using the same
US9499614B2 (en) 2013-03-14 2016-11-22 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
US9522953B2 (en) 2013-10-18 2016-12-20 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
US9550826B2 (en) 2013-11-15 2017-01-24 Abbvie Inc. Glycoengineered binding protein compositions
US9598667B2 (en) 2013-10-04 2017-03-21 Abbvie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins

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US7157276B2 (en) 2003-06-20 2007-01-02 Biogen Idec Inc. Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
EP2204190A1 (en) * 2003-07-15 2010-07-07 Chugai Seiyaku Kabushiki Kaisha IgM production by transformed cells and methods for quantifying said IgM production
JP4762717B2 (en) 2003-10-09 2011-08-31 中外製薬株式会社 IgM high concentration stabilization solution
JP4671864B2 (en) 2003-10-09 2011-04-20 中外製薬株式会社 Method for stabilizing protein solutions
US7598083B2 (en) 2004-10-29 2009-10-06 Centocor, Inc. Chemically defined media compositions
AR053416A1 (en) 2005-11-10 2007-05-09 Protech Pharma S A COMBINATION OF GLICOISOFORMS FOR THE TREATMENT OR PREVENTION OF SEPTICEMIA, TRANSGENIC CELLULAR LINE PRODUCING ERYTHROPOYETINE GLICOFORMES, PHARMACEUTICAL COMPOSITION THAT INCLUDES SUCH COMBINATION, PROCEDURES TO OBTAIN THE CELLULAR PROCEDURE
NZ597334A (en) 2006-09-13 2014-02-28 Abbott Lab Cell culture improvements
TW200907062A (en) 2007-03-28 2009-02-16 Medarex Inc Methods of gene amplification and expression
WO2010071800A1 (en) * 2008-12-19 2010-06-24 Schering Corporation Feed supplement for mammalian cell culture and methods of use
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
CN104822826B (en) 2012-10-15 2019-04-30 百时美施贵宝公司 The mammalian cell culture process generated for albumen
JP6464100B2 (en) * 2013-03-08 2019-02-06 ニュークローン・バイオロジクス・ピーティーワイ・リミテッド Cell expression system
WO2014143205A1 (en) 2013-03-12 2014-09-18 Abbvie Inc. Human antibodies that bind human tnf-alpha and methods of preparing the same
US9017687B1 (en) 2013-10-18 2015-04-28 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same using displacement chromatography
EP2968544A4 (en) * 2013-03-15 2016-10-12 Hoffmann La Roche Cell culture media and methods of antibody production
WO2015023505A1 (en) * 2013-08-12 2015-02-19 Merck Sharp & Dohme Corp. Methods and compositions for co-expression of polypeptides of interest and il6
WO2016007764A1 (en) * 2014-07-09 2016-01-14 Abbvie Inc. Methods for modulating the glycosylation profile of recombinant proteins using non-commonly used sugars
EP3354737B1 (en) * 2017-01-25 2020-08-19 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Cell-free protein synthesis system

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9365645B1 (en) 2011-04-27 2016-06-14 Abbvie, Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US9505834B2 (en) 2011-04-27 2016-11-29 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
US9359434B2 (en) 2012-04-20 2016-06-07 Abbvie, Inc. Cell culture methods to reduce acidic species
US9290568B2 (en) 2012-09-02 2016-03-22 Abbvie, Inc. Methods to control protein heterogeneity
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
US9499614B2 (en) 2013-03-14 2016-11-22 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
US9598667B2 (en) 2013-10-04 2017-03-21 Abbvie Inc. Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins
US9499616B2 (en) 2013-10-18 2016-11-22 Abbvie Inc. Modulated lysine variant species compositions and methods for producing and using the same
US9522953B2 (en) 2013-10-18 2016-12-20 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
US9550826B2 (en) 2013-11-15 2017-01-24 Abbvie Inc. Glycoengineered binding protein compositions

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WO2003046162A2 (en) 2003-06-05
AU2002356749A1 (en) 2003-06-10

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