CN103889454B - 重组成对碱性氨基酸蛋白酶的制剂 - Google Patents

重组成对碱性氨基酸蛋白酶的制剂 Download PDF

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Publication number
CN103889454B
CN103889454B CN201280038218.5A CN201280038218A CN103889454B CN 103889454 B CN103889454 B CN 103889454B CN 201280038218 A CN201280038218 A CN 201280038218A CN 103889454 B CN103889454 B CN 103889454B
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Prior art keywords
amino acid
composition
acid protease
polysorbate
paired
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CN201280038218.5A
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Chinese (zh)
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CN103889454A (zh
Inventor
M·哈斯拉赫尔
A·齐特科维兹
C·怀特
K·弗兰克
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Takeda Pharmaceutical Co Ltd
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Baishen Co
Baxter Healthcare SA
Baxalta GmbH
Baxter International Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6454—Dibasic site splicing serine proteases, e.g. kexin (3.4.21.61); furin (3.4.21.75) and other proprotein convertases
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21075—Furin (3.4.21.75)

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201280038218.5A 2011-06-02 2012-06-04 重组成对碱性氨基酸蛋白酶的制剂 Active CN103889454B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161492712P 2011-06-02 2011-06-02
US61/492,712 2011-06-02
PCT/US2012/040790 WO2012167271A1 (en) 2011-06-02 2012-06-04 Formulations of recombinant furin

Publications (2)

Publication Number Publication Date
CN103889454A CN103889454A (zh) 2014-06-25
CN103889454B true CN103889454B (zh) 2017-04-05

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CN201280038218.5A Active CN103889454B (zh) 2011-06-02 2012-06-04 重组成对碱性氨基酸蛋白酶的制剂

Country Status (14)

Country Link
US (2) US8877473B2 (enExample)
EP (1) EP2714087B1 (enExample)
JP (2) JP5797837B2 (enExample)
KR (1) KR102050609B1 (enExample)
CN (1) CN103889454B (enExample)
AR (1) AR086672A1 (enExample)
AU (2) AU2012261813B2 (enExample)
BR (1) BR112013030880B1 (enExample)
CA (1) CA2837948C (enExample)
ES (1) ES2715289T3 (enExample)
RU (1) RU2610436C2 (enExample)
SG (2) SG195261A1 (enExample)
TW (1) TWI586802B (enExample)
WO (1) WO2012167271A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4443135A3 (en) * 2013-08-20 2024-12-18 Yokogawa Fluence Analytics, Inc. Characterization of polymer and colloid solutions
TWI743023B (zh) * 2014-05-21 2021-10-21 日商Ｋｍ生物醫藥股份有限公司 基質金屬蛋白酶 7(mmp-7)聚集體之單體化方法
TWI666319B (zh) 2014-08-12 2019-07-21 美商巴克斯歐塔公司 在分泌ｆｕｒｉｎ之哺乳動物表現系統中生產經完全加工且具功能性之因子Ｘ
CA3068121A1 (en) 2017-06-23 2018-12-27 Baxalta Incorporated Purification of factor viii subspecies

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL9000917A (nl) 1989-10-25 1991-05-16 Holland Biotechnology Farmaceutisch preparaat met endoproteolytische activiteit; werkwijze voor endoproteolytische processing van (precursor) eiwitten en voor de (micro) biologische bereiding van eiwitten.
ATE158816T1 (de) 1990-11-26 1997-10-15 Genetics Inst Expression von pace in wirtszellen und verfahren zu dessen verwendung
ZA965368B (en) * 1995-07-14 1997-01-14 Novo Nordisk As A pharmaceutical formulation
AT404838B (de) 1995-11-24 1999-03-25 Immuno Ag Herstellung von proteinen aus pro-proteinen durch fusionsproteine abgeleitet von furin oder furinanalogen
US5876992A (en) * 1996-07-03 1999-03-02 Molecular Biology Resources, Inc. Method and formulation for stabilization of enzymes
US6596526B1 (en) 2000-06-09 2003-07-22 Baxter Aktiengesellschaft Furin polypeptides with improved characteristics
US7033991B2 (en) * 2001-07-16 2006-04-25 Board Of Supervisors Of Louisiana State University And Agriculture And Mechanical College Inhibiting furin with polybasic peptides
ATE507822T1 (de) * 2003-12-19 2011-05-15 Novo Nordisk Healthcare Ag Stabilisierte zusammensetzungen von faktor-vii- polypeptiden
DE102006008613A1 (de) * 2006-02-24 2007-08-30 Dade Behring Marburg Gmbh Stabilisierte Zubereitungen von Serin-Endopeptidasen, deren Herstellung und Verwendung
US8343748B2 (en) * 2007-05-22 2013-01-01 Baxter International Inc. Preparative purification process for human furin
SG10201805749QA (en) 2007-12-31 2018-08-30 Baxalta Inc Substantially animal protein-free recombinant furin and methods for producing same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"弗林蛋白酶：一种广泛参与前体蛋白切割的内切蛋白酶";王涛等;《医学分子生物学杂志》;20061231;第3卷(第3期);第202-205页 *

Also Published As

Publication number Publication date
ES2715289T3 (es) 2019-06-03
BR112013030880A2 (pt) 2017-06-20
US20120329128A1 (en) 2012-12-27
AU2012261813B2 (en) 2017-04-20
RU2610436C2 (ru) 2017-02-10
TW201249989A (en) 2012-12-16
US8877473B2 (en) 2014-11-04
EP2714087B1 (en) 2018-10-31
JP2016006106A (ja) 2016-01-14
EP2714087A1 (en) 2014-04-09
AU2017202050A1 (en) 2017-04-20
US20150079068A1 (en) 2015-03-19
CA2837948C (en) 2018-08-21
US9662376B2 (en) 2017-05-30
JP5797837B2 (ja) 2015-10-21
AU2012261813A1 (en) 2013-12-19
SG10201604488TA (en) 2016-07-28
JP2014519506A (ja) 2014-08-14
JP6064007B2 (ja) 2017-01-18
RU2013157927A (ru) 2015-07-20
BR112013030880B1 (pt) 2022-04-12
CA2837948A1 (en) 2012-12-06
KR20140050625A (ko) 2014-04-29
SG195261A1 (en) 2013-12-30
AR086672A1 (es) 2014-01-15
CN103889454A (zh) 2014-06-25
KR102050609B1 (ko) 2019-11-29
TWI586802B (zh) 2017-06-11
WO2012167271A1 (en) 2012-12-06

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