PL2337580T3 - Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej - Google Patents

Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej

Info

Publication number
PL2337580T3
PL2337580T3 PL09782562T PL09782562T PL2337580T3 PL 2337580 T3 PL2337580 T3 PL 2337580T3 PL 09782562 T PL09782562 T PL 09782562T PL 09782562 T PL09782562 T PL 09782562T PL 2337580 T3 PL2337580 T3 PL 2337580T3
Authority
PL
Poland
Prior art keywords
factor viii
recombinantly produced
stabilized compositions
produced factor
stabilized
Prior art date
Application number
PL09782562T
Other languages
English (en)
Inventor
Brita Rippner
Josefin ÖSTERBERG
Ulrika Nilsson
Elsa Ivarsson
Irène 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
Publication of PL2337580T3 publication Critical patent/PL2337580T3/pl

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)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (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)
PL09782562T 2008-09-03 2009-09-03 Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej PL2337580T3 (pl)

Applications Claiming Priority (4)

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
EP09782562A EP2337580B1 (en) 2008-09-03 2009-09-03 Stabilized compositions for recombinantly produced factor viii

Publications (1)

Publication Number Publication Date
PL2337580T3 true PL2337580T3 (pl) 2012-08-31

Family

ID=39791048

Family Applications (1)

Application Number Title Priority Date Filing Date
PL09782562T PL2337580T3 (pl) 2008-09-03 2009-09-03 Stabilizowane kompozycje czynnika VIII produkowanego metodami rekombinacji genetycznej

Country Status (19)

Country Link
US (4) US20110178019A1 (pl)
EP (1) EP2337580B1 (pl)
JP (2) JP5960990B2 (pl)
KR (3) KR20110073434A (pl)
CN (3) CN102143759A (pl)
AT (1) ATE551050T1 (pl)
AU (1) AU2009289212B2 (pl)
BR (1) BRPI0918589B1 (pl)
CA (1) CA2735376C (pl)
DK (1) DK2337580T3 (pl)
ES (1) ES2382443T3 (pl)
IL (1) IL211083A (pl)
MX (1) MX2011002316A (pl)
PL (1) PL2337580T3 (pl)
PT (1) PT2337580E (pl)
RU (1) RU2510279C3 (pl)
SI (1) SI2337580T1 (pl)
WO (1) WO2010026186A1 (pl)
ZA (1) ZA201101605B (pl)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2193809E (pt) 1999-02-22 2015-08-24 Baxter Int Formulações de fator viii livres de albumina
BRPI0921429B1 (pt) * 2008-11-07 2022-07-12 Takeda Pharmaceutical Company Limited Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável
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
CN114848614A (zh) * 2013-07-18 2022-08-05 曼金德公司 热稳定性干粉药物组合物和方法
CA2934705C (en) 2014-01-20 2020-03-31 Octapharma Ag A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag
NZ729629A (en) * 2014-08-04 2021-12-24 Csl Ltd Factor viii formulation
CA2961739C (en) * 2014-08-20 2024-04-30 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
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
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
US20220305089A1 (en) 2019-08-16 2022-09-29 Octapharma Ag Stabilizing buffer for factor viii and 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
CZ290342B6 (cs) * 1992-10-02 2002-07-17 Genetics Institute Inc. Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby
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
PT2193809E (pt) * 1999-02-22 2015-08-24 Baxter Int Formulações de fator viii livres de albumina
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
CA2517310C (en) * 2003-02-28 2015-11-24 Chugai Seiyaku Kabushiki Kaisha Stabilized protein-containing formulations comprising a poloxamer
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
WO2006103298A2 (en) * 2005-04-01 2006-10-05 Novo Nordisk Health Care Ag Blood coagulation fviii analogues
CN101415445A (zh) * 2006-03-31 2009-04-22 巴克斯特国际公司 聚乙二醇化的因子ⅷ
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
EP2300497B1 (en) * 2008-06-24 2012-08-08 Octapharma AG A process of purifying coagulation factor viii
US20110236412A1 (en) * 2008-09-24 2011-09-29 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine

Also Published As

Publication number Publication date
SI2337580T1 (sl) 2012-06-29
JP5960990B2 (ja) 2016-08-02
US20170189494A1 (en) 2017-07-06
JP2015129158A (ja) 2015-07-16
KR20160114194A (ko) 2016-10-04
BRPI0918589A2 (pt) 2017-04-11
RU2011112787A (ru) 2012-10-10
CN107049964B (zh) 2020-06-02
KR101691070B1 (ko) 2016-12-29
PT2337580E (pt) 2012-05-28
AU2009289212B2 (en) 2015-02-12
KR20110073434A (ko) 2011-06-29
IL211083A0 (en) 2011-07-31
CA2735376C (en) 2016-11-29
EP2337580B1 (en) 2012-03-28
IL211083A (en) 2016-09-29
ATE551050T1 (de) 2012-04-15
MX2011002316A (es) 2011-05-10
CN102143759A (zh) 2011-08-03
RU2510279C3 (ru) 2017-04-17
KR20160093743A (ko) 2016-08-08
RU2510279C2 (ru) 2014-03-27
DK2337580T3 (da) 2012-07-09
AU2009289212A1 (en) 2010-03-11
ZA201101605B (en) 2011-10-26
US20110178019A1 (en) 2011-07-21
US20150190478A1 (en) 2015-07-09
JP6010155B2 (ja) 2016-10-19
KR101691443B1 (ko) 2016-12-30
BRPI0918589B1 (pt) 2021-07-13
WO2010026186A1 (en) 2010-03-11
JP2012502004A (ja) 2012-01-26
CN107049964A (zh) 2017-08-18
ES2382443T3 (es) 2012-06-08
EP2337580A1 (en) 2011-06-29
CN107050437A (zh) 2017-08-18
CA2735376A1 (en) 2010-03-11
US20190358301A1 (en) 2019-11-28

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