DE69729786T2 - Hochkonzentrierte, lyophilisierte und flüssige faktor-ix formulierungen - Google Patents

Hochkonzentrierte, lyophilisierte und flüssige faktor-ix formulierungen Download PDF

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Publication number
DE69729786T2
DE69729786T2 DE69729786T DE69729786T DE69729786T2 DE 69729786 T2 DE69729786 T2 DE 69729786T2 DE 69729786 T DE69729786 T DE 69729786T DE 69729786 T DE69729786 T DE 69729786T DE 69729786 T2 DE69729786 T2 DE 69729786T2
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DE
Germany
Prior art keywords
factor
concentration
arginine
composition according
protein
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.)
Expired - Lifetime
Application number
DE69729786T
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German (de)
English (en)
Other versions
DE69729786D1 (de
Inventor
Chandra Webb
Lawrence Bush
G. Robert SCHAUB
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.)
Genetics Institute LLC
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Genetics Institute LLC
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24366077&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69729786(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genetics Institute LLC filed Critical Genetics Institute LLC
Application granted granted Critical
Publication of DE69729786D1 publication Critical patent/DE69729786D1/de
Publication of DE69729786T2 publication Critical patent/DE69729786T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
DE69729786T 1996-01-25 1997-01-09 Hochkonzentrierte, lyophilisierte und flüssige faktor-ix formulierungen Expired - Lifetime DE69729786T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US591332 1996-01-25
US08/591,332 US5770700A (en) 1996-01-25 1996-01-25 Liquid factor IX formulations
PCT/US1997/000747 WO1997026909A1 (en) 1996-01-25 1997-01-09 Highly concentrated, lyophilized, and liquid factor ix formulations

Publications (2)

Publication Number Publication Date
DE69729786D1 DE69729786D1 (de) 2004-08-12
DE69729786T2 true DE69729786T2 (de) 2005-07-14

Family

ID=24366077

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69729786T Expired - Lifetime DE69729786T2 (de) 1996-01-25 1997-01-09 Hochkonzentrierte, lyophilisierte und flüssige faktor-ix formulierungen

Country Status (8)

Country Link
US (1) US5770700A (enExample)
EP (1) EP0876155B1 (enExample)
JP (4) JP2000504327A (enExample)
AT (1) ATE270557T1 (enExample)
AU (1) AU726498B2 (enExample)
CA (1) CA2241319A1 (enExample)
DE (1) DE69729786T2 (enExample)
WO (1) WO1997026909A1 (enExample)

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US7790856B2 (en) 1998-04-07 2010-09-07 Janssen Alzheimer Immunotherapy Humanized antibodies that recognize beta amyloid peptide
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US7112576B1 (en) 1999-12-10 2006-09-26 Regents Of The University Of Minnesota Compositions and methods for cryopreservation of peripheral blood lymphocytes
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US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
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US7700751B2 (en) 2000-12-06 2010-04-20 Janssen Alzheimer Immunotherapy Humanized antibodies that recognize β-amyloid peptide
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AU2002351755A1 (en) * 2001-12-21 2003-07-15 Novo Nordisk A/S Liquid composition of modified factor vii polypeptides
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DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
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US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
BRPI0311959B8 (pt) 2002-06-21 2021-05-25 Novo Nordisk Healthcare Ag composição, métodos para preparar um polipeptídeo estável do fator vii, e para tratar uma síndrome responsiva do fator vii, e, uso do polipeptídeo do fator vii
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
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US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
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KR101293503B1 (ko) 2003-08-14 2013-08-07 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 액상 수성 약학적 조성물
KR20130026498A (ko) * 2003-12-19 2013-03-13 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 안정화된 조성물
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Also Published As

Publication number Publication date
AU1750097A (en) 1997-08-20
JP4879104B2 (ja) 2012-02-22
JP2007262090A (ja) 2007-10-11
JP2000504327A (ja) 2000-04-11
CA2241319A1 (en) 1997-07-31
JP2010189433A (ja) 2010-09-02
US5770700A (en) 1998-06-23
WO1997026909A1 (en) 1997-07-31
ATE270557T1 (de) 2004-07-15
EP0876155A1 (en) 1998-11-11
JP2006257099A (ja) 2006-09-28
AU726498B2 (en) 2000-11-09
DE69729786D1 (de) 2004-08-12
EP0876155B1 (en) 2004-07-07

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