BR112013030880B1 - Composição aquosa estabilizada de furina recombinante - Google Patents

Composição aquosa estabilizada de furina recombinante Download PDF

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Publication number
BR112013030880B1
BR112013030880B1 BR112013030880-0A BR112013030880A BR112013030880B1 BR 112013030880 B1 BR112013030880 B1 BR 112013030880B1 BR 112013030880 A BR112013030880 A BR 112013030880A BR 112013030880 B1 BR112013030880 B1 BR 112013030880B1
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BR
Brazil
Prior art keywords
composition
rfurin
furin
sugar
ppm
Prior art date
Application number
BR112013030880-0A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112013030880A2 (pt
Inventor
Meinhard Hasslacher
Andrzej Citkowicz
Catherine White
Ken Franke
Original Assignee
Takeda Pharmaceutical Company Limited
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 Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of BR112013030880A2 publication Critical patent/BR112013030880A2/pt
Publication of BR112013030880B1 publication Critical patent/BR112013030880B1/pt

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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
    • 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)
    • 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

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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)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (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)
BR112013030880-0A 2011-06-02 2012-06-04 Composição aquosa estabilizada de furina recombinante BR112013030880B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161492712P 2011-06-02 2011-06-02
US61/492712 2011-06-02
PCT/US2012/040790 WO2012167271A1 (en) 2011-06-02 2012-06-04 Formulations of recombinant furin

Publications (2)

Publication Number Publication Date
BR112013030880A2 BR112013030880A2 (pt) 2017-06-20
BR112013030880B1 true BR112013030880B1 (pt) 2022-04-12

Family

ID=46705014

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013030880-0A BR112013030880B1 (pt) 2011-06-02 2012-06-04 Composição aquosa estabilizada de furina recombinante

Country Status (14)

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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9664608B2 (en) * 2013-08-20 2017-05-30 Advanced Polymer Monitoring Technologies, 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
AR102048A1 (es) 2014-08-12 2017-02-01 Baxalta Inc Producción del factor x completamente procesado y funcional en un sistema de expresión de mamífero de secreción de furina
EP3642225A1 (en) 2017-06-23 2020-04-29 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.
JP4236698B2 (ja) 1990-11-26 2009-03-11 ジェネティックス インスティチュート，リミテッド ライアビリティ カンパニー 宿主細胞でのｐａｃｅの発現およびその使用法
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
RU2373953C2 (ru) * 2003-12-19 2009-11-27 Ново Нордиск Хелс Кеа Аг Стабилизированная композиция, содержащая полипептид фактора vii
DE102006008613A1 (de) * 2006-02-24 2007-08-30 Dade Behring Marburg Gmbh Stabilisierte Zubereitungen von Serin-Endopeptidasen, deren Herstellung und Verwendung
KR101660533B1 (ko) 2007-05-22 2016-10-10 박스알타 인코퍼레이티드 인간 푸린의 분취 정제 방법
ES2735173T3 (es) * 2007-12-31 2019-12-16 Baxalta GmbH Furina recombinante sustancialmente libre de proteína animal y métodos para producir la misma

Also Published As

Publication number Publication date
EP2714087B1 (en) 2018-10-31
TW201249989A (en) 2012-12-16
JP6064007B2 (ja) 2017-01-18
US20150079068A1 (en) 2015-03-19
RU2610436C2 (ru) 2017-02-10
JP2014519506A (ja) 2014-08-14
US20120329128A1 (en) 2012-12-27
AU2012261813B2 (en) 2017-04-20
CA2837948A1 (en) 2012-12-06
CN103889454A (zh) 2014-06-25
TWI586802B (zh) 2017-06-11
AR086672A1 (es) 2014-01-15
CN103889454B (zh) 2017-04-05
AU2012261813A1 (en) 2013-12-19
BR112013030880A2 (pt) 2017-06-20
SG10201604488TA (en) 2016-07-28
RU2013157927A (ru) 2015-07-20
KR20140050625A (ko) 2014-04-29
US8877473B2 (en) 2014-11-04
SG195261A1 (en) 2013-12-30
JP5797837B2 (ja) 2015-10-21
US9662376B2 (en) 2017-05-30
EP2714087A1 (en) 2014-04-09
KR102050609B1 (ko) 2019-11-29
CA2837948C (en) 2018-08-21
ES2715289T3 (es) 2019-06-03
AU2017202050A1 (en) 2017-04-20
JP2016006106A (ja) 2016-01-14
WO2012167271A1 (en) 2012-12-06

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B25A Requested transfer of rights approved

Owner name: BAXALTA GMBH (CH) , BAXALTA INCORPORATED (US)

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B25A Requested transfer of rights approved

Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED (JP)

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 04/06/2012, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 14A ANUIDADE.