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HRP20120903T4 - Tekuća formulacija koja sadrži visoku koncentraciju protutijela - Google Patents

Tekuća formulacija koja sadrži visoku koncentraciju protutijela Download PDF

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Publication number
HRP20120903T4
HRP20120903T4 HRP20120903TT HRP20120903T HRP20120903T4 HR P20120903 T4 HRP20120903 T4 HR P20120903T4 HR P20120903T T HRP20120903T T HR P20120903TT HR P20120903 T HRP20120903 T HR P20120903T HR P20120903 T4 HRP20120903 T4 HR P20120903T4
Authority
HR
Croatia
Prior art keywords
antibody
formulation
liquid formulation
antibodies
high concentration
Prior art date
Application number
HRP20120903TT
Other languages
English (en)
Inventor
Toshiyuki Morichika
Daisuke Kameoka
Yoshimi Imaeda
Terutoshi Maeda
Oliver Boris Stauch
Original Assignee
Chugai Seiyaku Kabushiki Kaisha
F. Hoffmann-La Roche 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40824372&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20120903(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chugai Seiyaku Kabushiki Kaisha, F. Hoffmann-La Roche Ag filed Critical Chugai Seiyaku Kabushiki Kaisha
Publication of HRP20120903T1 publication Critical patent/HRP20120903T1/hr
Publication of HRP20120903T4 publication Critical patent/HRP20120903T4/hr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Analytical Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Claims (4)

1. Stabilna tekuća formulacija koja sadrži protutijela koja sadrži 180 mg/ml humaniziranog anti-IL-6 receptorskog protutijela MRA, 100 mM arginina i 30 mM metionina, 0,5 mg/ml polisorbata 80, 20 mM otopine histidinskog pufera i ima pH 6,0.
2. Formulacija prema zahtjevu 1, naznačena time što je inhibirana dimerizacija molekula protutijela.
3. Formulacija prema zahtjevu 1, naznačena time što je inhibirana deamidacija molekula protutijela.
4. Postupak za inhibiciju dimerizacije molekula protutijela u tekućoj formulaciji koja sadrži protutijelo, naznačen time što uključuje dodavanje arginina i metionina u tekuću formulaciju, pri čemu formulacija sadrži 180 mg/ml protutijela, pri čemu je arginin dodan formulaciji u količini od 100 mM, i metionin u količini od 30 mM, formulacija nadalje sadrži polisorbat 80 u količini od 0,5 mg/ml, otopinu histidinskog pufera u koncentraciji od 20 mM, te ima pH od 6,0, te pri čemu je protutijelo humanizirano anti- IL-6 receptorsko protutijelo MRA.
HRP20120903TT 2007-12-27 2008-12-26 Tekuća formulacija koja sadrži visoku koncentraciju protutijela HRP20120903T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2007336310 2007-12-27
EP08866971.8A EP2238985B2 (en) 2007-12-27 2008-12-26 High concentration antibody-containing liquid formulation
PCT/JP2008/073798 WO2009084659A1 (ja) 2007-12-27 2008-12-26 高濃度抗体含有溶液製剤

Publications (2)

Publication Number Publication Date
HRP20120903T1 HRP20120903T1 (hr) 2012-12-31
HRP20120903T4 true HRP20120903T4 (hr) 2022-09-02

Family

ID=40824372

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20120903TT HRP20120903T4 (hr) 2007-12-27 2008-12-26 Tekuća formulacija koja sadrži visoku koncentraciju protutijela

Country Status (31)

Country Link
US (12) US8568720B2 (hr)
EP (1) EP2238985B2 (hr)
JP (9) JP4937358B2 (hr)
KR (1) KR101083616B1 (hr)
CN (2) CN101883588B (hr)
AR (3) AR069969A1 (hr)
AU (1) AU2008344292B2 (hr)
BR (1) BRPI0818903B8 (hr)
CA (1) CA2708627C (hr)
CL (1) CL2008003910A1 (hr)
CO (1) CO6450630A2 (hr)
CR (1) CR11594A (hr)
CY (1) CY1113616T1 (hr)
DK (1) DK2238985T4 (hr)
EC (1) ECSP10010370A (hr)
ES (1) ES2389881T5 (hr)
HR (1) HRP20120903T4 (hr)
IL (2) IL206548A (hr)
MA (1) MA31934B1 (hr)
MX (1) MX2010004399A (hr)
MY (1) MY159450A (hr)
NZ (1) NZ586378A (hr)
PE (1) PE20091174A1 (hr)
PL (1) PL2238985T5 (hr)
PT (1) PT2238985E (hr)
RU (2) RU2497544C2 (hr)
SG (1) SG2013049325A (hr)
SI (1) SI2238985T2 (hr)
TW (1) TWI375566B (hr)
UA (1) UA104134C2 (hr)
WO (1) WO2009084659A1 (hr)

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