ATE551050T1 - Stabilisierte zusammensetzungen für rekombinant hergestellten faktor viii - Google Patents

Stabilisierte zusammensetzungen für rekombinant hergestellten faktor viii

Info

Publication number
ATE551050T1
ATE551050T1 AT09782562T AT09782562T ATE551050T1 AT E551050 T1 ATE551050 T1 AT E551050T1 AT 09782562 T AT09782562 T AT 09782562T AT 09782562 T AT09782562 T AT 09782562T AT E551050 T1 ATE551050 T1 AT E551050T1
Authority
AT
Austria
Prior art keywords
factor viii
recombinantly produced
stabilized compositions
produced factor
stabilized
Prior art date
Application number
AT09782562T
Other languages
English (en)
Inventor
Brita Rippner
Josefin Oesterberg
Ulrika Nilsson
Elsa Ivarsson
Irene Agerkvist
Original Assignee
Octapharma Ag
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 Octapharma Ag filed Critical Octapharma Ag
Application granted granted Critical
Publication of ATE551050T1 publication Critical patent/ATE551050T1/de

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AT09782562T 2008-09-03 2009-09-03 Stabilisierte zusammensetzungen für rekombinant hergestellten faktor viii ATE551050T1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13640208P 2008-09-03 2008-09-03
EP08163554 2008-09-03
PCT/EP2009/061402 WO2010026186A1 (en) 2008-09-03 2009-09-03 New protecting compositions for recombinantly produced factor viii

Publications (1)

Publication Number Publication Date
ATE551050T1 true ATE551050T1 (de) 2012-04-15

Family

ID=39791048

Family Applications (1)

Application Number Title Priority Date Filing Date
AT09782562T ATE551050T1 (de) 2008-09-03 2009-09-03 Stabilisierte zusammensetzungen für rekombinant hergestellten faktor viii

Country Status (19)

Country Link
US (4) US20110178019A1 (de)
EP (1) EP2337580B1 (de)
JP (2) JP5960990B2 (de)
KR (3) KR101691070B1 (de)
CN (3) CN102143759A (de)
AT (1) ATE551050T1 (de)
AU (1) AU2009289212B2 (de)
BR (1) BRPI0918589B1 (de)
CA (1) CA2735376C (de)
DK (1) DK2337580T3 (de)
ES (1) ES2382443T3 (de)
IL (1) IL211083A (de)
MX (1) MX2011002316A (de)
PL (1) PL2337580T3 (de)
PT (1) PT2337580E (de)
RU (1) RU2510279C3 (de)
SI (1) SI2337580T1 (de)
WO (1) WO2010026186A1 (de)
ZA (1) ZA201101605B (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2921180B1 (de) 1999-02-22 2019-08-14 University of Connecticut Albuminfreie Faktor-VIII-Formulierungen
NZ593190A (en) 2008-11-07 2013-01-25 Baxter Int Factor viii formulations
CN102232932B (zh) * 2010-04-27 2013-06-05 重庆莱美药业股份有限公司 果胶-阿霉素轭合物的冻干制剂及制备方法
MX375448B (es) * 2013-07-18 2025-03-06 Mannkind Corp Composiciones farmacéuticas en polvo seco estables al calor y métodos.
RU2695428C2 (ru) 2014-01-20 2019-07-23 Октафарма Аг СПОСОБ ПРОИЗВОДСТВА ФАКТОРА VIII, ИМЕЮЩЕГО УЛУЧШЕННОЕ СООТНОШЕНИЕ FVIII:C/FVIII:Ag
US10238718B2 (en) * 2014-08-04 2019-03-26 Csl Limited Factor VIII formulation
KR20250150675A (ko) * 2014-08-20 2025-10-20 포톨라 파마슈티컬스, 인코포레이티드 인자 xa 해독제용 동결건조된 제형
CN108883160B (zh) * 2016-02-24 2022-06-28 博尔托拉制药公司 因子xa解毒剂的冻干制剂
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
EP4013389A1 (de) 2019-08-16 2022-06-22 Octapharma AG Stabilisierender puffer für faktor viii und vwf
CN116479088B (zh) * 2022-11-15 2024-11-05 江苏默乐生物科技股份有限公司 一种生物试剂冻干保存的试剂组合、试剂盒、方法及应用

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5605884A (en) * 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
DE4001451A1 (de) * 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
DE4111393A1 (de) * 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
US5288853A (en) * 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
DE69329795T2 (de) * 1992-10-02 2001-07-05 Genetics Institute, Inc. Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
SE9301581D0 (sv) * 1993-05-07 1993-05-07 Kabi Pharmacia Ab Protein formulation
SE9403915D0 (sv) * 1994-11-14 1994-11-14 Annelie Almstedt Process A
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
US6005007A (en) * 1997-07-18 1999-12-21 Farmer; Luc J. Retinoids, methods for their production and use
US6358703B1 (en) * 1998-12-10 2002-03-19 Bayer Corporation Expression system for factor VIII
EP2921180B1 (de) * 1999-02-22 2019-08-14 University of Connecticut Albuminfreie Faktor-VIII-Formulierungen
AU6558400A (en) * 1999-08-17 2001-03-13 Novo Nordisk A/S Stabilisation of freeze-dried cake
SE0004086D0 (sv) * 2000-11-08 2000-11-08 Pharmacia Ab Preparation process
GB0207092D0 (en) * 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
KR101235507B1 (ko) * 2003-02-28 2013-02-20 추가이 세이야쿠 가부시키가이샤 단백질을 함유하는 안정화 제제
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
JP2008534559A (ja) * 2005-04-01 2008-08-28 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト 血液凝固fviii類似体
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WO2008073620A2 (en) * 2006-11-02 2008-06-19 Neose Technologies, Inc. Manufacturing process for the production of polypeptides expressed in insect cell-lines
US20110014676A1 (en) * 2007-06-29 2011-01-20 Battelle Memorial Institute Protein stabilization
KR20160104740A (ko) * 2008-06-24 2016-09-05 옥타파마 아게 응고 인자 viii을 정제하는 방법
BRPI0918988A2 (pt) * 2008-09-24 2015-12-01 Stabilitech Ltd métodos para preservar um polipeptídeo e um imunógeno de vacina, e para preparar uma vacina, pó seco, produto preservado, frasco selado, ampola ou seringa, uso de um excipiente, e, vacina.

Also Published As

Publication number Publication date
MX2011002316A (es) 2011-05-10
US20170189494A1 (en) 2017-07-06
AU2009289212A1 (en) 2010-03-11
BRPI0918589A2 (pt) 2017-04-11
AU2009289212B2 (en) 2015-02-12
IL211083A (en) 2016-09-29
EP2337580A1 (de) 2011-06-29
KR20110073434A (ko) 2011-06-29
DK2337580T3 (da) 2012-07-09
CN107050437A (zh) 2017-08-18
BRPI0918589B1 (pt) 2021-07-13
RU2510279C2 (ru) 2014-03-27
JP2012502004A (ja) 2012-01-26
KR101691070B1 (ko) 2016-12-29
CN107049964A (zh) 2017-08-18
KR101691443B1 (ko) 2016-12-30
SI2337580T1 (sl) 2012-06-29
WO2010026186A1 (en) 2010-03-11
JP6010155B2 (ja) 2016-10-19
KR20160114194A (ko) 2016-10-04
RU2510279C3 (ru) 2017-04-17
CN107049964B (zh) 2020-06-02
RU2011112787A (ru) 2012-10-10
US20150190478A1 (en) 2015-07-09
ZA201101605B (en) 2011-10-26
PL2337580T3 (pl) 2012-08-31
JP2015129158A (ja) 2015-07-16
EP2337580B1 (de) 2012-03-28
KR20160093743A (ko) 2016-08-08
CN102143759A (zh) 2011-08-03
CA2735376A1 (en) 2010-03-11
CA2735376C (en) 2016-11-29
PT2337580E (pt) 2012-05-28
US20110178019A1 (en) 2011-07-21
JP5960990B2 (ja) 2016-08-02
IL211083A0 (en) 2011-07-31
ES2382443T3 (es) 2012-06-08
US20190358301A1 (en) 2019-11-28

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