AU2012261813B2 - Formulations of recombinant furin - Google Patents

Formulations of recombinant furin Download PDF

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Publication number
AU2012261813B2
AU2012261813B2 AU2012261813A AU2012261813A AU2012261813B2 AU 2012261813 B2 AU2012261813 B2 AU 2012261813B2 AU 2012261813 A AU2012261813 A AU 2012261813A AU 2012261813 A AU2012261813 A AU 2012261813A AU 2012261813 B2 AU2012261813 B2 AU 2012261813B2
Authority
AU
Australia
Prior art keywords
var
composition
rfurin
ppm
sugar
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
AU2012261813A
Other languages
English (en)
Other versions
AU2012261813A1 (en
Inventor
Andrzej CITKOWICZ
Ken Franke
Meinhard Hasslacher
Catherine White
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical 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 Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of AU2012261813A1 publication Critical patent/AU2012261813A1/en
Assigned to Baxalta GmbH, BAXALTA INCORPORATED reassignment Baxalta GmbH Request for Assignment Assignors: BAXTER HEALTHCARE S.A., BAXTER INTERNATIONAL INC.
Priority to AU2017202050A priority Critical patent/AU2017202050A1/en
Application granted granted Critical
Publication of AU2012261813B2 publication Critical patent/AU2012261813B2/en
Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED reassignment TAKEDA PHARMACEUTICAL COMPANY LIMITED Request for Assignment Assignors: Baxalta GmbH, BAXALTA INCORPORATED
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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)

Landscapes

  • 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)
AU2012261813A 2011-06-02 2012-06-04 Formulations of recombinant furin Ceased AU2012261813B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2017202050A AU2017202050A1 (en) 2011-06-02 2017-03-28 Formulations of recombinant furin

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2017202050A Division AU2017202050A1 (en) 2011-06-02 2017-03-28 Formulations of recombinant furin

Publications (2)

Publication Number Publication Date
AU2012261813A1 AU2012261813A1 (en) 2013-12-19
AU2012261813B2 true AU2012261813B2 (en) 2017-04-20

Family

ID=46705014

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2012261813A Ceased AU2012261813B2 (en) 2011-06-02 2012-06-04 Formulations of recombinant furin
AU2017202050A Abandoned AU2017202050A1 (en) 2011-06-02 2017-03-28 Formulations of recombinant furin

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2017202050A Abandoned AU2017202050A1 (en) 2011-06-02 2017-03-28 Formulations of recombinant furin

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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides
US20070231315A1 (en) * 2006-02-24 2007-10-04 Andrea Lichte Stabilized preparations of serine endopeptidases, their preparation and use

Family Cites Families (9)

* 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
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides
US20070231315A1 (en) * 2006-02-24 2007-10-04 Andrea Lichte Stabilized preparations of serine endopeptidases, their preparation and use

Also Published As

Publication number Publication date
ES2715289T3 (es) 2019-06-03
BR112013030880A2 (pt) 2017-06-20
US20120329128A1 (en) 2012-12-27
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
CN103889454B (zh) 2017-04-05
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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Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: BAXALTA GMBH; BAXALTA INCORPORATED

Free format text: FORMER APPLICANT(S): BAXTER HEALTHCARE S.A.; BAXTER INTERNATIONAL INC.

FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Free format text: FORMER OWNER(S): BAXALTA GMBH; BAXALTA INCORPORATED