BRPI0918589A2 - composições de proteção para fator viii recombinantemente produzido - Google Patents

composições de proteção para fator viii recombinantemente produzido

Info

Publication number
BRPI0918589A2
BRPI0918589A2 BRPI0918589A BRPI0918589A BRPI0918589A2 BR PI0918589 A2 BRPI0918589 A2 BR PI0918589A2 BR PI0918589 A BRPI0918589 A BR PI0918589A BR PI0918589 A BRPI0918589 A BR PI0918589A BR PI0918589 A2 BRPI0918589 A2 BR PI0918589A2
Authority
BR
Brazil
Prior art keywords
factor viii
recombinantly produced
protection compositions
produced factor
compositions
Prior art date
Application number
BRPI0918589A
Other languages
English (en)
Inventor
Rippner Brita
Ivarsson Elsa
Agerkvist Irene
Osterberg Josefin
Nilsson Ulrika
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 BRPI0918589A2 publication Critical patent/BRPI0918589A2/pt
Publication of BRPI0918589B1 publication Critical patent/BRPI0918589B1/pt

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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
BRPI0918589-5A 2008-09-03 2009-09-03 Composições de proteção para fator viii recombinantemente produzido BRPI0918589B1 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US13640208P 2008-09-03 2008-09-03
US61/136,402 2008-09-03
EP08163554 2008-09-03
EP08163554.2 2008-09-03
PCT/EP2009/061402 WO2010026186A1 (en) 2008-09-03 2009-09-03 New protecting compositions for recombinantly produced factor viii

Publications (2)

Publication Number Publication Date
BRPI0918589A2 true BRPI0918589A2 (pt) 2017-04-11
BRPI0918589B1 BRPI0918589B1 (pt) 2021-07-13

Family

ID=39791048

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0918589-5A BRPI0918589B1 (pt) 2008-09-03 2009-09-03 Composições de proteção para fator viii recombinantemente produzido

Country Status (19)

Country Link
US (4) US20110178019A1 (pt)
EP (1) EP2337580B1 (pt)
JP (2) JP5960990B2 (pt)
KR (3) KR20110073434A (pt)
CN (3) CN107049964B (pt)
AT (1) ATE551050T1 (pt)
AU (1) AU2009289212B2 (pt)
BR (1) BRPI0918589B1 (pt)
CA (1) CA2735376C (pt)
DK (1) DK2337580T3 (pt)
ES (1) ES2382443T3 (pt)
IL (1) IL211083A (pt)
MX (1) MX2011002316A (pt)
PL (1) PL2337580T3 (pt)
PT (1) PT2337580E (pt)
RU (1) RU2510279C3 (pt)
SI (1) SI2337580T1 (pt)
WO (1) WO2010026186A1 (pt)
ZA (1) ZA201101605B (pt)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK1820516T3 (da) 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
MX339060B (es) * 2008-11-07 2016-05-09 Baxter Int Formulaciones del factor viii.
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
CN106687126B (zh) * 2014-08-04 2020-07-28 杰特有限公司 因子viii制剂
EP3750556A1 (en) * 2014-08-20 2020-12-16 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
WO2017147522A1 (en) * 2016-02-24 2017-08-31 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
EP3443346B1 (en) * 2016-04-13 2023-08-30 Medimmune, LLC Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
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
CA2124690C (en) * 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
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
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
DE60009926T2 (de) * 1999-08-17 2005-04-07 Novo Nordisk Health Care Ag Stabilisierung von gefriergetrocknetem kuchen
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
EP1871801A2 (en) * 2005-04-01 2008-01-02 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
US20080207487A1 (en) * 2006-11-02 2008-08-28 Neose Technologies, Inc. Manufacturing process for the production of polypeptides expressed in insect cell-lines
WO2009006301A2 (en) * 2007-06-29 2009-01-08 Battelle Memorial Institute Protein stabilization
EP2300497B1 (en) * 2008-06-24 2012-08-08 Octapharma AG A process of purifying coagulation factor viii
MX2011003074A (es) * 2008-09-24 2011-04-19 Stabilitech Ltd Metodo para conservar polipeptidos utilizando un azucar y polietilenimina.

Also Published As

Publication number Publication date
IL211083A (en) 2016-09-29
JP5960990B2 (ja) 2016-08-02
KR20110073434A (ko) 2011-06-29
PT2337580E (pt) 2012-05-28
CN107050437A (zh) 2017-08-18
CN102143759A (zh) 2011-08-03
JP6010155B2 (ja) 2016-10-19
ES2382443T3 (es) 2012-06-08
JP2015129158A (ja) 2015-07-16
DK2337580T3 (da) 2012-07-09
CN107049964B (zh) 2020-06-02
KR20160093743A (ko) 2016-08-08
EP2337580B1 (en) 2012-03-28
CA2735376A1 (en) 2010-03-11
BRPI0918589B1 (pt) 2021-07-13
KR101691443B1 (ko) 2016-12-30
EP2337580A1 (en) 2011-06-29
WO2010026186A1 (en) 2010-03-11
AU2009289212B2 (en) 2015-02-12
PL2337580T3 (pl) 2012-08-31
KR101691070B1 (ko) 2016-12-29
IL211083A0 (en) 2011-07-31
RU2011112787A (ru) 2012-10-10
RU2510279C3 (ru) 2017-04-17
MX2011002316A (es) 2011-05-10
ZA201101605B (en) 2011-10-26
KR20160114194A (ko) 2016-10-04
CA2735376C (en) 2016-11-29
US20150190478A1 (en) 2015-07-09
SI2337580T1 (sl) 2012-06-29
US20110178019A1 (en) 2011-07-21
AU2009289212A1 (en) 2010-03-11
ATE551050T1 (de) 2012-04-15
CN107049964A (zh) 2017-08-18
US20190358301A1 (en) 2019-11-28
US20170189494A1 (en) 2017-07-06
JP2012502004A (ja) 2012-01-26
RU2510279C2 (ru) 2014-03-27

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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]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]
B08G Application fees: restoration [chapter 8.7 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

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
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 03/09/2009, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.