BR112017017303A2 - método para obtenção de clones de células de alta produtividade, linhagem de células de mieloma, e, anticorpo recombinante humanizado. - Google Patents

método para obtenção de clones de células de alta produtividade, linhagem de células de mieloma, e, anticorpo recombinante humanizado.

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Publication number
BR112017017303A2
BR112017017303A2 BR112017017303-4A BR112017017303A BR112017017303A2 BR 112017017303 A2 BR112017017303 A2 BR 112017017303A2 BR 112017017303 A BR112017017303 A BR 112017017303A BR 112017017303 A2 BR112017017303 A2 BR 112017017303A2
Authority
BR
Brazil
Prior art keywords
protein
culture medium
cell clones
high yield
antibody molecule
Prior art date
Application number
BR112017017303-4A
Other languages
English (en)
Chinese (zh)
Other versions
BR112017017303B8 (pt
BR112017017303B1 (pt
Inventor
Chea Meylen
Palacios Julio
Arias Miguel
Calvo Loany
González Tamara
Pérez Rolando
Bai Zhi
Liu Yuemao
Xiao Kaiheng
Chen Xiao
He Zhenhua
Cai Yangliu
Yang Zhenhua
Bai Xianhong
Original Assignee
Biotech Pharmaceutical Co. Ltd
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.)
Filing date
Publication date
Application filed by Biotech Pharmaceutical Co. Ltd filed Critical Biotech Pharmaceutical Co. Ltd
Publication of BR112017017303A2 publication Critical patent/BR112017017303A2/pt
Publication of BR112017017303B1 publication Critical patent/BR112017017303B1/pt
Publication of BR112017017303B8 publication Critical patent/BR112017017303B8/pt

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/44Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3084Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated gangliosides
    • 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • C12N5/0602Vertebrate cells
    • C12N5/0693Tumour cells; Cancer cells
    • C12N5/0694Cells of blood, e.g. leukemia cells, myeloma cells
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • C12N2500/90Serum-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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

é fornecido um método para a obtenção de clones de células de expressão estável de alto rendimento a partir de linhagens de células de mieloma em um meio de cultura isento de proteína. o método é usado para a produção industrial de um anticorpo recombinante e inclui três estágios: (1) adaptação a um meio de cultura isento de proteína, cultura estática de células em uma baixa densidade e redução gradual de um suplemento rico em gordura para um meio de cultura químico; (2) adaptação a um meio de cultura isento de proteína; cultura de células em uma alta densidade e uso de um sistema de fermentação por perfusão em escala laboratorial; e (3) rastreamento de clones de células de expressão estável de alto rendimento das células após a fermentação terminar. o clone celular pode ser usado para produzir um anticorpo recombinante anti-neugcgm3 14f7 humanizado.
BR112017017303A 2015-02-14 2016-03-11 Método para obtenção de clones de células de alta produtividade BR112017017303B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201510080631.3A CN104651314B (zh) 2015-02-14 2015-02-14 获得高产稳定表达细胞克隆的方法及由此获得的抗体分子
CN201510080631.3 2015-02-14
PCT/CN2016/076135 WO2016127954A1 (zh) 2015-02-14 2016-03-11 获得高产稳定表达细胞克隆的方法及由此获得的抗体分子

Publications (3)

Publication Number Publication Date
BR112017017303A2 true BR112017017303A2 (pt) 2018-04-10
BR112017017303B1 BR112017017303B1 (pt) 2023-08-08
BR112017017303B8 BR112017017303B8 (pt) 2024-03-05

Family

ID=53242962

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017017303A BR112017017303B8 (pt) 2015-02-14 2016-03-11 Método para obtenção de clones de células de alta produtividade

Country Status (17)

Country Link
US (1) US10457747B2 (pt)
JP (1) JP2018506306A (pt)
KR (1) KR20180029948A (pt)
CN (1) CN104651314B (pt)
AU (1) AU2016218641C1 (pt)
BR (1) BR112017017303B8 (pt)
CA (1) CA2974027C (pt)
CO (1) CO2017008087A2 (pt)
CU (1) CU20170106A7 (pt)
EA (1) EA201791828A1 (pt)
IL (1) IL253932A0 (pt)
MX (1) MX2017010421A (pt)
MY (1) MY192147A (pt)
NZ (1) NZ735485A (pt)
SG (1) SG11201706595TA (pt)
TN (1) TN2017000302A1 (pt)
WO (1) WO2016127954A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104651314B (zh) * 2015-02-14 2018-06-19 百泰生物药业有限公司 获得高产稳定表达细胞克隆的方法及由此获得的抗体分子
EP3257935A4 (en) * 2016-03-11 2018-08-08 Biotech Pharmaceutical Co. Ltd. Method for obtaining high-yield, stable-expression cell clones and antibody molecules obtained thereby
CN113480652B (zh) * 2021-07-30 2023-04-07 成都景泽生物制药有限公司 一种重组cho细胞发酵培养生产重组egfr抗体活性分子的方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CU22731A1 (es) * 1998-02-05 2002-02-28 Centro Inmunologia Molecular Anticuerpo monoclonal que reconoce el oligosacárido ácido siálico n´glicolilado-galactosa-glucosa (ngcneu-gal-glu) en tumores malignos y composiciones farmacéuticas que los contienen
GB0208041D0 (en) * 2002-04-08 2002-05-22 Lonza Biologics Plc Method of culturing animal cells
CU23097A1 (es) * 2002-10-23 2005-11-18 Centro Inmunologia Molecular Método para la obtención de líneas celulares en medio libre de proteína y líneas celulares obtenidas por este método
CU23403A1 (es) * 2003-04-23 2009-08-04 Centro Inmunologia Molecular Anticuerpos recombinantes y fragmentos que reconocen el gangliósido n-glicolil gm3 y su uso para diagnóstico y tratamiento de tumores
EP1689878A4 (en) * 2003-11-03 2007-02-14 Centocor Inc METHOD FOR MAINTAINING LOW SHEAR IN A BIOTECHNOLOGICAL SYSTEM
CU24120B1 (es) * 2012-03-01 2015-08-27 Ct De Inmunología Molecular Anticuerpos recombinantes con especificidad dual por los gangliósidos n-acetil gm3 y n-glicolil gm3
CN104152415B (zh) * 2014-08-13 2015-09-30 百泰生物药业有限公司 获得高产稳定表达重组抗体的骨髓瘤细胞株的方法及应用
CN104651314B (zh) * 2015-02-14 2018-06-19 百泰生物药业有限公司 获得高产稳定表达细胞克隆的方法及由此获得的抗体分子

Also Published As

Publication number Publication date
CU20170106A7 (es) 2018-06-05
MX2017010421A (es) 2018-04-26
AU2016218641B2 (en) 2019-10-31
CA2974027A1 (en) 2016-08-18
IL253932A0 (en) 2017-10-31
AU2016218641C1 (en) 2020-02-27
JP2018506306A (ja) 2018-03-08
KR20180029948A (ko) 2018-03-21
MY192147A (en) 2022-08-01
TN2017000302A1 (en) 2019-01-16
NZ735485A (en) 2019-08-30
BR112017017303B8 (pt) 2024-03-05
SG11201706595TA (en) 2017-09-28
US20180016353A1 (en) 2018-01-18
AU2016218641A1 (en) 2017-10-05
US10457747B2 (en) 2019-10-29
BR112017017303B1 (pt) 2023-08-08
CA2974027C (en) 2021-02-16
CO2017008087A2 (es) 2017-10-10
WO2016127954A1 (zh) 2016-08-18
CN104651314A (zh) 2015-05-27
EA201791828A1 (ru) 2017-12-29
CN104651314B (zh) 2018-06-19

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/03/2016, OBSERVADAS AS CONDICOES LEGAIS

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: REFERENTE A RPI 2744 DE 08/08/2023, QUANTO AO ITEM (54) TITULO.