AU2002363339B2 - Stable liquid pharmaceutical formulation of IGG antibodies - Google Patents

Stable liquid pharmaceutical formulation of IGG antibodies Download PDF

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Publication number
AU2002363339B2
AU2002363339B2 AU2002363339A AU2002363339A AU2002363339B2 AU 2002363339 B2 AU2002363339 B2 AU 2002363339B2 AU 2002363339 A AU2002363339 A AU 2002363339A AU 2002363339 A AU2002363339 A AU 2002363339A AU 2002363339 B2 AU2002363339 B2 AU 2002363339B2
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AU
Australia
Prior art keywords
clear
antibody
formulation
buffer
succinate
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.)
Ceased, expires
Application number
AU2002363339A
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English (en)
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AU2002363339A1 (en
Inventor
Shanti G. Duvur
Supriya Gupta
Elizabet A. Kaisheva
Malathy Subramanian
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AbbVie Biotechnology Ltd
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AbbVie Biotechnology Ltd
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Application filed by AbbVie Biotechnology Ltd filed Critical AbbVie Biotechnology Ltd
Publication of AU2002363339A1 publication Critical patent/AU2002363339A1/en
Assigned to PDL BIOPHARMA, INC. reassignment PDL BIOPHARMA, INC. Request for Assignment Assignors: PROTEIN DESIGN LABS
Application granted granted Critical
Publication of AU2002363339B2 publication Critical patent/AU2002363339B2/en
Assigned to FACET BIOTECH CORPORATION reassignment FACET BIOTECH CORPORATION Request for Assignment Assignors: PDL BIOPHARMA, INC.
Assigned to ABBOTT BIOTHERAPEUTICS CORP. reassignment ABBOTT BIOTHERAPEUTICS CORP. Request to Amend Deed and Register Assignors: FACET BIOTECH CORPORATION
Assigned to ABBVIE BIOTHERAPEUTICS INC. reassignment ABBVIE BIOTHERAPEUTICS INC. Request to Amend Deed and Register Assignors: ABBOTT BIOTHERAPEUTICS CORP.
Assigned to ABBVIE BIOTECHNOLOGY LTD reassignment ABBVIE BIOTECHNOLOGY LTD Request for Assignment Assignors: ABBVIE BIOTHERAPEUTICS INC.
Ceased legal-status Critical Current
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/249Interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • C07K16/246IL-2
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
AU2002363339A 2001-11-08 2002-11-08 Stable liquid pharmaceutical formulation of IGG antibodies Ceased AU2002363339B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33750901P 2001-11-08 2001-11-08
US60/337,509 2001-11-08
PCT/US2002/036093 WO2003039485A2 (en) 2001-11-08 2002-11-08 Stable liquid pharmaceutical formulation of igg antibodies

Publications (2)

Publication Number Publication Date
AU2002363339A1 AU2002363339A1 (en) 2003-07-24
AU2002363339B2 true AU2002363339B2 (en) 2008-02-07

Family

ID=23320826

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2002363339A Ceased AU2002363339B2 (en) 2001-11-08 2002-11-08 Stable liquid pharmaceutical formulation of IGG antibodies

Country Status (16)

Country Link
US (3) US20030138417A1 (cg-RX-API-DMAC7.html)
EP (1) EP1441589B1 (cg-RX-API-DMAC7.html)
JP (2) JP5290489B2 (cg-RX-API-DMAC7.html)
KR (1) KR100913714B1 (cg-RX-API-DMAC7.html)
CN (1) CN1292655C (cg-RX-API-DMAC7.html)
AT (1) ATE556591T1 (cg-RX-API-DMAC7.html)
AU (1) AU2002363339B2 (cg-RX-API-DMAC7.html)
CA (1) CA2466034C (cg-RX-API-DMAC7.html)
CY (1) CY2016044I2 (cg-RX-API-DMAC7.html)
DK (1) DK1441589T3 (cg-RX-API-DMAC7.html)
ES (1) ES2392073T3 (cg-RX-API-DMAC7.html)
IL (2) IL161677A0 (cg-RX-API-DMAC7.html)
LU (1) LU93314I2 (cg-RX-API-DMAC7.html)
NZ (1) NZ532896A (cg-RX-API-DMAC7.html)
PT (1) PT1441589E (cg-RX-API-DMAC7.html)
WO (1) WO2003039485A2 (cg-RX-API-DMAC7.html)

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