BRPI0514694B8 - processo de produção de etanercept em cultura de células de produção em larga escala - Google Patents

processo de produção de etanercept em cultura de células de produção em larga escala

Info

Publication number
BRPI0514694B8
BRPI0514694B8 BRPI0514694A BRPI0514694A BRPI0514694B8 BR PI0514694 B8 BRPI0514694 B8 BR PI0514694B8 BR PI0514694 A BRPI0514694 A BR PI0514694A BR PI0514694 A BRPI0514694 A BR PI0514694A BR PI0514694 B8 BRPI0514694 B8 BR PI0514694B8
Authority
BR
Brazil
Prior art keywords
cumulative
glutamine
amino acid
molar ratio
production
Prior art date
Application number
BRPI0514694A
Other languages
English (en)
Inventor
Lasko Daniel
Drapeau Denis
R Mercer James
Wang Wenge
Luan Yen-Tuang
Original Assignee
Pfizer Ireland Pharmaceuticals
Wyeth Res Ireland Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35500648&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0514694(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Ireland Pharmaceuticals, Wyeth Res Ireland Limited filed Critical Pfizer Ireland Pharmaceuticals
Publication of BRPI0514694A publication Critical patent/BRPI0514694A/pt
Publication of BRPI0514694B1 publication Critical patent/BRPI0514694B1/pt
Publication of BRPI0514694B8 publication Critical patent/BRPI0514694B8/pt

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • C12P21/02—Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62—DNA sequences coding for fusion proteins
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • 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
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/30—Organic components
    • C12N2500/32—Amino acids
    • 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
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/90—Serum-free medium, which may still contain naturally-sourced components
    • 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
    • C12N2500/00—Specific components of cell culture medium
    • C12N2500/90—Serum-free medium, which may still contain naturally-sourced components
    • C12N2500/95—Protein-free medium and culture conditions

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

produção de proteína de fusão tnfr-ig. a presente invenção refere-se a um sistema aperfeiçoado para produção em grande escala de proteínas e/ou tnfr-igs em culturas de células, particularmente em meios caracterizados por um ou mais de: i) uma concentração cumulativa de aminoácido maior que cerca de 70 mm; ii) uma razão molar cumulativa de glutamina para asparagina de menos que cerca de 2; iii) uma razão molar cumulativa de glutamina para aminoácido total de menos que cerca de 0,2; iv) uma razão molar cumulativa de íon inorgânico para aminoácido total de cerca de 0,4 para 1; ou v) uma concentração cumulativa combinada de asparagina e glutamina entre cerca de 16 e 36 mm, é provido. o uso de um tal sistema permite produção de altos níveis de proteína e menos acumulação de certos fatores indesejáveis como amônio e/ou lactato. adicionalmente, processos de cultura incluindo um desvio de temperatura, tipicamente incluindo uma diminuição em temperatura quando a cultura atingiu cerca de 20-80% de sua densidade máxima de células, são providos. alternativamente ou adicionalmente, a presente invenção provê processos de modo que, após atingirem um pico, níveis de lactato e/ou amônio na cultura diminuem com tempo.
BRPI0514694A 2004-08-27 2005-08-26 processo de produção de etanercept em cultura de células de produção em larga escala BRPI0514694B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60537904P 2004-08-27 2004-08-27
US60/605,379 2004-08-27
PCT/US2005/030439 WO2006026447A2 (en) 2004-08-27 2005-08-26 PRODUCTION OF TNFR-Ig FUSION PROTEIN

Publications (3)

Publication Number Publication Date
BRPI0514694A BRPI0514694A (pt) 2008-06-17
BRPI0514694B1 BRPI0514694B1 (pt) 2019-04-24
BRPI0514694B8 true BRPI0514694B8 (pt) 2021-05-25

Family

ID=35500648

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0514694A BRPI0514694B8 (pt) 2004-08-27 2005-08-26 processo de produção de etanercept em cultura de células de produção em larga escala

Country Status (38)

Country Link
US (1) US7300773B2 (pt)
EP (2) EP1992697B1 (pt)
JP (3) JP2008511330A (pt)
KR (1) KR100988451B1 (pt)
CN (2) CN101061231B (pt)
AR (2) AR050537A1 (pt)
AT (2) ATE461285T1 (pt)
AU (1) AU2005280036B2 (pt)
BR (1) BRPI0514694B8 (pt)
CA (1) CA2578138C (pt)
CL (1) CL2017000577A1 (pt)
CR (2) CR8998A (pt)
CY (2) CY1109721T1 (pt)
DE (2) DE602005020076D1 (pt)
DK (2) DK1992697T3 (pt)
EC (1) ECSP077354A (pt)
EG (1) EG26922A (pt)
ES (2) ES2335518T3 (pt)
GT (2) GT200500233A (pt)
HK (2) HK1121497A1 (pt)
HN (1) HN2005000485A (pt)
HR (2) HRP20100011T1 (pt)
IL (1) IL181588A (pt)
MX (1) MX2007002381A (pt)
MY (1) MY137803A (pt)
NO (1) NO344785B1 (pt)
NZ (1) NZ579208A (pt)
PE (2) PE20060815A1 (pt)
PL (2) PL1781802T3 (pt)
PT (2) PT1781802E (pt)
RS (2) RS51072B (pt)
RU (1) RU2458988C2 (pt)
SI (2) SI1992697T1 (pt)
SV (1) SV2006002211A (pt)
TW (1) TWI364458B (pt)
UA (1) UA89383C2 (pt)
WO (1) WO2006026447A2 (pt)
ZA (1) ZA200701672B (pt)

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