JP2021517805A - Ｈｕ１４．１８Ｋ３２２Ａモノクローナル抗体を産生するためのプロセス - Google Patents

Ｈｕ１４．１８Ｋ３２２Ａモノクローナル抗体を産生するためのプロセス Download PDF

Info

Publication number
JP2021517805A
JP2021517805A JP2020543750A JP2020543750A JP2021517805A JP 2021517805 A JP2021517805 A JP 2021517805A JP 2020543750 A JP2020543750 A JP 2020543750A JP 2020543750 A JP2020543750 A JP 2020543750A JP 2021517805 A JP2021517805 A JP 2021517805A
Authority
JP
Japan
Prior art keywords
antibody
monoclonal antibody
cells
fucosylated
cell culture
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
JP2020543750A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2019161167A5 (https=
JP2021517805A5 (https=
Inventor
マアー，ミカエル，エム．
レッディバリ，ムラリダー
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
StJude Children's Research Hospital inc
Original Assignee
StJude Children's Research Hospital inc
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 StJude Children's Research Hospital inc filed Critical StJude Children's Research Hospital inc
Publication of JP2021517805A publication Critical patent/JP2021517805A/ja
Publication of JPWO2019161167A5 publication Critical patent/JPWO2019161167A5/ja
Publication of JP2021517805A5 publication Critical patent/JP2021517805A5/ja
Ceased legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076—Immunoglobulins [IG], 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
    • C07K16/3084—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IG], 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
    • 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
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • 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
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • 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
    • C12P21/005—Glycopeptides, glycoproteins
    • 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
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C12N2500/34—Sugars

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Cell Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Oncology (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2020543750A 2018-02-15 2019-02-15 Ｈｕ１４．１８Ｋ３２２Ａモノクローナル抗体を産生するためのプロセス Ceased JP2021517805A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862630971P 2018-02-15 2018-02-15
US62/630,971 2018-02-15
PCT/US2019/018169 WO2019161167A1 (en) 2018-02-15 2019-02-15 Process for producing hu14.18k322a monoclonal antibody

Publications (3)

Publication Number Publication Date
JP2021517805A true JP2021517805A (ja) 2021-07-29
JPWO2019161167A5 JPWO2019161167A5 (https=) 2022-02-24
JP2021517805A5 JP2021517805A5 (https=) 2022-02-24

Family

ID=67620073

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020543750A Ceased JP2021517805A (ja) 2018-02-15 2019-02-15 Ｈｕ１４．１８Ｋ３２２Ａモノクローナル抗体を産生するためのプロセス

Country Status (9)

Country Link
US (1) US20210002384A1 (https=)
EP (1) EP3752535A4 (https=)
JP (1) JP2021517805A (https=)
KR (1) KR20200123156A (https=)
CN (1) CN112105647A (https=)
AU (1) AU2019220667A1 (https=)
CA (1) CA3091344A1 (https=)
IL (2) IL315353A (https=)
WO (1) WO2019161167A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7494722B2 (ja) * 2020-12-16 2024-06-04 株式会社島津製作所 糖鎖質量分析データ解析装置、及び糖鎖質量分析データ解析用プログラム
WO2023235762A2 (en) * 2022-06-01 2023-12-07 Tg Therapeutics, Inc. Commercial-scale recombinant protein production in rat hybridoma cells
WO2024040194A1 (en) 2022-08-17 2024-02-22 Capstan Therapeutics, Inc. Conditioning for in vivo immune cell engineering
CN115894604B (zh) * 2022-12-16 2024-01-23 康日百奥生物科技(苏州)有限公司 重组蛋白澄清纯化方法
US12311033B2 (en) 2023-05-31 2025-05-27 Capstan Therapeutics, Inc. Lipid nanoparticle formulations and compositions
WO2025076113A1 (en) 2023-10-05 2025-04-10 Capstan Therapeutics, Inc. Ionizable cationic lipids with conserved spacing and lipid nanoparticles
WO2025076127A1 (en) 2023-10-05 2025-04-10 Capstan Therapeutics, Inc. Constrained ionizable cationic lipids and lipid nanoparticles
WO2025217454A2 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Ionizable cationic lipids and lipid nanoparticles
WO2025217452A1 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Constrained ionizable cationic lipids and lipid nanoparticles

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
CLINICAL CANCER RESEARCH, vol. 23, no. 21, JPN6023003226, 2017, pages 6441 - 6449, ISSN: 0005347844 *
CYTOTECHNOLOGY, vol. 64, JPN6023003229, 2012, pages 249 - 265, ISSN: 0005347847 *
DRUGS FUTURE, vol. 35, no. 8, JPN6023003222, 2010, pages 1 - 15, ISSN: 0005347843 *
JOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY, vol. Volume 2011, Article ID 379123, JPN6023003227, 2011, pages 1 - 7, ISSN: 0005347845 *
JOURNAL OF CLINICAL ONCOLOGY, vol. 32, no. 14, JPN6023003221, 2014, pages 1445 - 1452, ISSN: 0005347842 *
PAIN, vol. 149, no. 1, JPN6023003228, 2010, pages 1 - 17, ISSN: 0005347846 *
日薬理誌, vol. 147, JPN6023003230, 2016, pages 235 - 240, ISSN: 0005347848 *

Also Published As

Publication number Publication date
EP3752535A1 (en) 2020-12-23
KR20200123156A (ko) 2020-10-28
CN112105647A (zh) 2020-12-18
IL315353A (en) 2024-11-01
EP3752535A4 (en) 2021-12-01
US20210002384A1 (en) 2021-01-07
WO2019161167A1 (en) 2019-08-22
AU2019220667A1 (en) 2020-09-17
IL276211A (en) 2020-09-30
IL276211B1 (en) 2024-10-01
IL276211B2 (en) 2025-02-01
CA3091344A1 (en) 2019-08-22

Similar Documents

Publication Publication Date Title
JP2021517805A (ja) Ｈｕ１４．１８Ｋ３２２Ａモノクローナル抗体を産生するためのプロセス
US20240327890A1 (en) Modulation of cell growth and glycosylation in recombinant glycoprotein production
EP2904092B1 (en) Compostions and methods for producing glycoproteins
CN113272440B (zh) 改变细胞培养物中产生的重组糖蛋白的糖基化谱的方法
AU2021258023B2 (en) Methods for modulating protein galactosylation profiles of recombinant proteins using peracetyl galactose
EP3337894A1 (en) Manufacturing of alkaline phosphatases
JP2026032016A (ja) 哺乳動物細胞培養プロセス
JP2021506323A (ja) ポリエーテルイオノフォアを使用するタンパク質マンノシル化プロファイルの調節方法
JP2025072512A (ja) スルフヒドリル化合物およびその誘導体を用いた酵素および経路調節
CA3118604C (en) Method for modifying the glycosylation profile of a recombinant glycoprotein produced in cell culture
今野由信 Process Development for Efficient Production of Antibodies with High Antibody-Dependent Cellular Cytotoxicity Activity from a YB2/0 Cell Line
HK1231927B (zh) 重组糖蛋白生产中的细胞生长和糖基化的调节

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220215

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220215

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230130

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230426

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230728

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20231003

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240202

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20240205

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20240326

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240617

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240913

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20241119

A045 Written measure of dismissal of application [lapsed due to lack of payment]

Free format text: JAPANESE INTERMEDIATE CODE: A045

Effective date: 20250324