CN109641971B - 抗体融合蛋白的制造方法 - Google Patents

抗体融合蛋白的制造方法 Download PDF

Info

Publication number
CN109641971B
CN109641971B CN201780051299.5A CN201780051299A CN109641971B CN 109641971 B CN109641971 B CN 109641971B CN 201780051299 A CN201780051299 A CN 201780051299A CN 109641971 B CN109641971 B CN 109641971B
Authority
CN
China
Prior art keywords
ser
gly
thr
leu
val
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.)
Active
Application number
CN201780051299.5A
Other languages
English (en)
Chinese (zh)
Other versions
CN109641971A (zh
Inventor
越村友理
园田启之
M·马特夫
柿本真司
福井刚
秦野勇吉
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.)
JCR Pharmaceuticals Co Ltd
Original Assignee
JCR Pharmaceuticals 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 JCR Pharmaceuticals Co Ltd filed Critical JCR Pharmaceuticals Co Ltd
Publication of CN109641971A publication Critical patent/CN109641971A/zh
Application granted granted Critical
Publication of CN109641971B publication Critical patent/CN109641971B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • 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)
    • 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)
    • C12N9/24—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
    • 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
    • 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
    • C12N5/10—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)

Landscapes

  • 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (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)
CN201780051299.5A 2016-08-25 2017-08-25 抗体融合蛋白的制造方法 Active CN109641971B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2016-164901 2016-08-25
JP2016164901 2016-08-25
PCT/JP2017/030470 WO2018038243A1 (ja) 2016-08-25 2017-08-25 抗体融合蛋白質の製造方法

Publications (2)

Publication Number Publication Date
CN109641971A CN109641971A (zh) 2019-04-16
CN109641971B true CN109641971B (zh) 2023-04-04

Family

ID=61246169

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201780051299.5A Active CN109641971B (zh) 2016-08-25 2017-08-25 抗体融合蛋白的制造方法

Country Status (11)

Country Link
US (1) US11512135B2 (enExample)
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)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6914193B2 (ja) 2015-06-24 2021-08-04 Ｊｃｒファーマ株式会社 Ｂｄｎｆを含む融合蛋白質
TWI769982B (zh) 2015-06-24 2022-07-11 日商Ｊｃｒ製藥股份有限公司 通過血腦障壁之抗人類運鐵蛋白受體抗體
NZ752703A (en) 2016-12-26 2022-09-30 Japan Chem Res Novel anti-human transferrin receptor antibody capable of penetrating blood-brain barrier
EP3561058B1 (en) 2016-12-26 2025-07-23 JCR Pharmaceuticals Co., Ltd. Fusion protein including bdnf
WO2019049967A1 (ja) 2017-09-07 2019-03-14 Ｊｃｒファーマ株式会社 水性医薬組成物
CA3076369A1 (en) 2017-10-02 2019-04-11 Denali Therapeutics Inc. Fusion proteins comprising enzyme replacement therapy enzymes
US20210038739A1 (en) * 2018-02-05 2021-02-11 Jcr Pharmaceuticals Co., Ltd. Method for Delivering Drug to Muscle
EP3560945A1 (en) * 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
JP6951051B2 (ja) * 2018-05-24 2021-10-20 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
MA71661A (fr) 2020-10-14 2025-05-30 Denali Therapeutics Inc. Protéines de fusion comprenant des enzymes sulfoglucosamine sulfohydrolase et méthodes associées
WO2022135457A1 (zh) * 2020-12-23 2022-06-30 广东菲鹏制药股份有限公司 一种抗pd-l1抗体及其应用
CN116997364A (zh) * 2021-02-11 2023-11-03 戴纳立制药公司 抗转铁蛋白受体融合蛋白及其使用方法
JP2022138142A (ja) 2021-03-09 2022-09-22 Ｊｃｒファーマ株式会社 抗体－リソソーム酵素融合蛋白質の製造方法
WO2023127879A1 (ja) * 2021-12-28 2023-07-06 Ｊｃｒファーマ株式会社 安全な遺伝子治療のための抗トランスフェリン受容体抗体と生理活性を有する蛋白質との融合蛋白質
JPWO2024010067A1 (enExample) * 2022-07-08 2024-01-11
WO2025137213A1 (en) 2023-12-20 2025-06-26 Denali Therapeutics Inc. Fusion proteins comprising acid alpha-glucosidase enzymes and methods thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1871252A (zh) * 2003-09-05 2006-11-29 Gtc生物治疗学公司 在转基因哺乳动物奶中生产融合蛋白的方法
CN101120087A (zh) * 2004-12-21 2008-02-06 森托科尔公司 抗-il-12抗体、表位、组合物、方法和用途
CN101622274A (zh) * 2006-12-12 2010-01-06 比奥雷克西斯药物公司 转铁蛋白融合蛋白库

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050100965A1 (en) 2003-11-12 2005-05-12 Tariq Ghayur IL-18 binding proteins
JP5065391B2 (ja) 2006-12-06 2012-10-31 日本ケミカルリサーチ株式会社 ヒトエリスロポエチンの製造方法
JP2009273427A (ja) 2008-05-16 2009-11-26 Jcr Pharmaceuticals Co Ltd 組換え体ヒトｆｓｈの製造方法
ES2699434T3 (es) 2008-10-31 2019-02-11 Wyeth Llc Purificación de proteínas ácidas utilizando cromatografía de hidroxiapatita cerámica
EP2485761B1 (en) * 2009-10-09 2019-02-27 Armagen, Inc. Methods and compositions for increasing iduronate 2-sulfatase activity in the cns
JP6018572B2 (ja) * 2011-01-25 2016-11-02 Ｊｃｒファーマ株式会社 組換えヒトイズロン酸−２−スルファターゼの製造方法
WO2012101671A1 (en) 2011-01-25 2012-08-02 Jcr Pharmaceuticals Co., Ltd. Method for production of human recombinant iduronate 2-sulfatase
BR112014013250A2 (pt) * 2011-12-01 2019-09-24 Angiochem Inc compostos com enzima alvo e usos dos mesmos
KR101380740B1 (ko) 2012-06-29 2014-04-11 쉐어 휴먼 제네텍 세러피스, 인코포레이티드 이듀로네이트-2-설파타제의 정제
WO2014016873A1 (en) 2012-07-26 2014-01-30 Jcr Pharmaceuticals Co., Ltd. Method for production of recombinant human alpha-galactosidase a
WO2015098989A1 (ja) 2013-12-25 2015-07-02 Ｊｃｒファーマ株式会社 血液脳関門を通過する新規抗トランスフェリン受容体抗体
JP6071018B2 (ja) 2014-10-31 2017-02-01 Ｊｃｒファーマ株式会社 組換えヒトＤＮａｓｅＩの製造方法
WO2016116966A1 (en) 2015-01-22 2016-07-28 Jcr Pharmaceuticals Co., Ltd. Method for purification of recombinant human alpha-galactosidase a from material containing contaminant host cell proteins

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1871252A (zh) * 2003-09-05 2006-11-29 Gtc生物治疗学公司 在转基因哺乳动物奶中生产融合蛋白的方法
CN101120087A (zh) * 2004-12-21 2008-02-06 森托科尔公司 抗-il-12抗体、表位、组合物、方法和用途
CN101622274A (zh) * 2006-12-12 2010-01-06 比奥雷克西斯药物公司 转铁蛋白融合蛋白库

Also Published As

Publication number Publication date
JP7232889B2 (ja) 2023-03-03
MX2019002252A (es) 2019-07-04
SG11201901495YA (en) 2019-03-28
US20190225700A1 (en) 2019-07-25
CA3034589A1 (en) 2018-03-01
BR112019003622A2 (pt) 2019-05-21
JP2018033454A (ja) 2018-03-08
EP3505538A1 (en) 2019-07-03
CN109641971A (zh) 2019-04-16
KR20190040040A (ko) 2019-04-16
JP6993814B2 (ja) 2022-01-14
AU2017316955B2 (en) 2022-03-03
EP3505538A4 (en) 2020-03-18
MX389073B (es) 2025-03-20
EP3505538B1 (en) 2024-05-01
KR102318480B1 (ko) 2021-10-28
US11512135B2 (en) 2022-11-29
WO2018038243A1 (ja) 2018-03-01
JP2022028959A (ja) 2022-02-16
AU2017316955A1 (en) 2019-03-21

Similar Documents

Publication Publication Date Title
CN109641971B (zh) 抗体融合蛋白的制造方法
CN110114078B (zh) 冷冻干燥制剂
KR102655498B1 (ko) 수성 의약 조성물
KR102807590B1 (ko) 혈액뇌관문을 통과하는 항인간 트랜스페린 수용체 항체
TWI833178B (zh) 通過血腦障壁之新穎抗人類運鐵蛋白受體抗體
KR20180020279A (ko) Bdnf를 포함하는 융합 단백질
CN116997352A (zh) 稳定的水性药物组合物或冷冻干燥药物组合物
WO2022191158A1 (ja) 抗体－リソソーム酵素融合蛋白質の製造方法
US20230323326A1 (en) Mutant of alpha-N-Acetylglucosaminidase
HK40000935A (en) Method for producing antibody fusion protein
HK40000935B (en) Method for producing antibody fusion protein
HK40007891A (en) Lyophilized preparation
HK40092923A (en) Mutant of alpha-n-acetylglucosaminidase
HK1245328B (zh) 通过血脑屏障的抗人转铁蛋白受体抗体

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40000935

Country of ref document: HK

GR01 Patent grant
GR01 Patent grant