JP6993814B2 - 抗体融合蛋白質の製造方法 - Google Patents

抗体融合蛋白質の製造方法 Download PDF

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JP6993814B2
JP6993814B2 JP2017161826A JP2017161826A JP6993814B2 JP 6993814 B2 JP6993814 B2 JP 6993814B2 JP 2017161826 A JP2017161826 A JP 2017161826A JP 2017161826 A JP2017161826 A JP 2017161826A JP 6993814 B2 JP6993814 B2 JP 6993814B2
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amino acid
acid sequence
antibody
seq
human
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JP2018033454A5 (enExample
JP2018033454A (ja
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友理 越村
啓之 薗田
ミロスラブ マテヴ
真司 柿本
剛 福井
勇吉 秦野
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JCR Pharmaceuticals Co Ltd
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    • 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
    • C07K16/2881—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD71
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
    • 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
    • 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
    • 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
    • C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • C12N5/069—Vascular Endothelial 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2462—Lysozyme (3.2.1.17)
    • 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
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017—Lysozyme (3.2.1.17)

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
JP2017161826A 2016-08-25 2017-08-25 抗体融合蛋白質の製造方法 Active JP6993814B2 (ja)

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EP (1) EP3505538B1 (enExample)
JP (2) JP6993814B2 (enExample)
KR (1) KR102318480B1 (enExample)
CN (1) CN109641971B (enExample)
AU (1) AU2017316955B2 (enExample)
BR (1) BR112019003622A2 (enExample)
CA (1) CA3034589A1 (enExample)
MX (1) MX389073B (enExample)
SG (1) SG11201901495YA (enExample)
WO (1) WO2018038243A1 (enExample)

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CN107849555B (zh) 2015-06-24 2022-01-04 Jcr制药股份有限公司 通过血脑屏障的抗人转铁蛋白受体抗体
US11130815B2 (en) 2015-06-24 2021-09-28 Jcr Pharmaceuticals Co., Ltd. Fusion proteins containing a BDNF and an anti-human transferrin receptor antibody
CN110100000B (zh) 2016-12-26 2023-06-20 Jcr制药股份有限公司 含有bdnf的融合蛋白
WO2018124121A1 (ja) 2016-12-26 2018-07-05 Ｊｃｒファーマ株式会社 血液脳関門を通過する新規な抗ヒトトランスフェリン受容体抗体
JP7188944B2 (ja) * 2017-09-07 2022-12-13 Ｊｃｒファーマ株式会社 水性医薬組成物
US20200277584A1 (en) 2017-10-02 2020-09-03 Denali Therapeutics Inc. Fusion proteins comprising enzyme replacement therapy enzymes
CN111683972A (zh) * 2018-02-05 2020-09-18 Jcr制药股份有限公司 用于将药剂递送至肌肉的方法
EP3560945A1 (en) * 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
WO2019224660A1 (ja) * 2018-05-24 2019-11-28 ＨＯＹＡ Ｔｅｃｈｎｏｓｕｒｇｉｃａｌ株式会社 吸着剤の生産方法
KR102692543B1 (ko) * 2018-10-26 2024-08-07 재단법인 목암생명과학연구소 Ids를 포함하는 융합 단백질 및 이의 용도
CR20230178A (es) 2020-10-14 2023-07-26 Denali Therapeutics Inc Proteínas de fusión que comprenden enzimas sulfoglucosamina sulfohidrolasa y métodos de estas
JP2024500511A (ja) * 2020-12-23 2024-01-09 広東菲鵬制▲薬▼股▲ふん▼有限公司 抗ｐｄ－ｌ１抗体及びその使用
WO2022174114A1 (en) * 2021-02-11 2022-08-18 Denali Therapeutics Inc. Anti-transferrin receptor fusion proteins and methods of use thereof
AU2022234150A1 (en) 2021-03-09 2023-09-28 Jcr Pharmaceuticals Co., Ltd. Method for producing antibody-lysosomal enzyme fusion protein
TW202334428A (zh) * 2021-12-28 2023-09-01 日商Ｊｃｒ製藥股份有限公司 用於安全的基因治療之抗轉鐵蛋白受體抗體與具有生理活性的蛋白質之融合蛋白質
WO2024010067A1 (ja) * 2022-07-08 2024-01-11 Ｊｃｒファーマ株式会社 中枢神経系疾患の治療のための、核酸分子、ベクター、組換え細胞及び薬剤
WO2025137213A1 (en) 2023-12-20 2025-06-26 Denali Therapeutics Inc. Fusion proteins comprising acid alpha-glucosidase enzymes and methods thereof

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AU2017316955B2 (en) 2022-03-03
BR112019003622A2 (pt) 2019-05-21
JP7232889B2 (ja) 2023-03-03
US20190225700A1 (en) 2019-07-25
JP2022028959A (ja) 2022-02-16
EP3505538B1 (en) 2024-05-01
KR20190040040A (ko) 2019-04-16
AU2017316955A1 (en) 2019-03-21
CN109641971B (zh) 2023-04-04
US11512135B2 (en) 2022-11-29
SG11201901495YA (en) 2019-03-28
EP3505538A1 (en) 2019-07-03
EP3505538A4 (en) 2020-03-18
JP2018033454A (ja) 2018-03-08
WO2018038243A1 (ja) 2018-03-01
MX2019002252A (es) 2019-07-04
MX389073B (es) 2025-03-20
KR102318480B1 (ko) 2021-10-28
CA3034589A1 (en) 2018-03-01
CN109641971A (zh) 2019-04-16

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