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AR075908A1 - PHARMACEUTICAL FORMULATION CONTAINING IMPROVED ANTIBODY MOLECULES, POLYPEPTIDES. METHOD FOR STABILIZING SOLUTION, ANTIBODY. - Google Patents

PHARMACEUTICAL FORMULATION CONTAINING IMPROVED ANTIBODY MOLECULES, POLYPEPTIDES. METHOD FOR STABILIZING SOLUTION, ANTIBODY.

Info

Publication number
AR075908A1
AR075908A1 ARP100100904A ARP100100904A AR075908A1 AR 075908 A1 AR075908 A1 AR 075908A1 AR P100100904 A ARP100100904 A AR P100100904A AR P100100904 A ARP100100904 A AR P100100904A AR 075908 A1 AR075908 A1 AR 075908A1
Authority
AR
Argentina
Prior art keywords
seq
sequence
cdr1
cdr2
cdr3
Prior art date
Application number
ARP100100904A
Other languages
Spanish (es)
Inventor
Mika Sakurai
Tetsuo Kojima
Hiroyuki Tsunoda
Tatsuhiko Tachibana
Atsuhiko Maeda
Yoshinobu Higuchi
Hirotake Shiraiwa
Tomoyuki Igawa
Shinya Ishii
Original Assignee
Chugai Pharmaceutical Co Ltd
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 Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Publication of AR075908A1 publication Critical patent/AR075908A1/en

Links

Classifications

    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/72—Increased effector function due to an Fc-modification
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

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

Abstract

Reivindicacion 1: Una formulacion farmacéutica, caracterizada porque comprende al menos un polipéptido seleccionado entre: (a) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:1 (CDR1 de VH4-M73), una CDR2 que comprende la secuencia de la SEQ ID N°:2 (CDR2 de VH4-M73) y una CDR3 que comprende la secuencia de la SEQ ID N°:3 (CDR3 de VH4-M73); (b) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:4 (CDR1 de VH3-M73), una CDR2 que comprende la secuencia de la SEQ ID N°:5 (CDR2 de VH3-M73) y una CDR3 que comprende la secuencia de la SEQ ID N°:6 (CDR3 de VH3-M73); (c) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:7 (CDR1 de VH5-M83), una CDR2 que comprende la secuencia de la SEQ ID N°:8 (CDR2 de VH5-M83) y una CDR3 que comprende la secuencia de la SEQ ID N°:9 (CDR3 de VH5-M83); (d) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:10 (CDR1 de VL1), una CDR2 que comprende la secuencia de la SEQ ID N°:11 (CDR2 de VL1) y una CDR3 que comprende la secuencia de la SEQ ID N°:12 (CDR3 de VL1); e) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:13 (CDR1 de VL3), una CDR2 que comprende la secuencia de la SEQ ID N°:14 (CDR2 de VL3) y una CDR3 que comprende la secuencia de la SEQ ID N°:15 (CDR3 de VL3); y (f) un polipéptido que comprende una CDR1 que comprende la secuencia de la SEQ ID N°:16 (CDR1 de VL5), una CDR2 que comprende la secuencia de la SEQ ID N°:17 (CDR2 de VL5) y una CDR3 que comprende la secuencia de la SEQ ID N°:18 (CDR3 de VL5). Reivindicacion 5: Una formulacion farmacéutica estable de acuerdo con cualquiera de las reivindicaciones 1 a 4, caracterizada porque comprende 1-500 mM de agente amortiguador de histidina y/o citrato, 1-1500 mM de al menos un aminoácido cationico, 1-200 mg/mL de anticuerpo, y 1-400 mM de un carbohidrato. Reivindicacion 12: La formulacion de acuerdo con cualquiera de las reivindicaciones 1 a 11, caracterizada porque contiene el polipéptido y/o anticuerpo en una cantidad inferior o igual a 240 mg/ml. Reivindicacion 15: La formulacion de acuerdo con cualquiera de las reivindicaciones 1 a 14, caracterizada porque la formulacion es líquida. Reivindicacion 16: La formulacion de acuerdo con la reivindicacion 15, caracterizada porque no se sometio a liofilizacion durante la preparacion de la misma.Claim 1: A pharmaceutical formulation, characterized in that it comprises at least one polypeptide selected from: (a) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 1 (CDR1 of VH4-M73), a CDR2 comprising the sequence of SEQ ID N °: 2 (CDR2 of VH4-M73) and a CDR3 comprising the sequence of SEQ ID N °: 3 (CDR3 of VH4-M73); (b) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 4 (CDR1 of VH3-M73), a CDR2 comprising the sequence of SEQ ID N °: 5 (CDR2 of VH3-M73) and a CDR3 comprising the sequence of SEQ ID N °: 6 (CDR3 of VH3-M73); (c) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 7 (CDR1 of VH5-M83), a CDR2 comprising the sequence of SEQ ID N °: 8 (CDR2 of VH5-M83) and a CDR3 comprising the sequence of SEQ ID N °: 9 (CDR3 of VH5-M83); (d) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 10 (CDR1 of VL1), a CDR2 comprising the sequence of SEQ ID N °: 11 (CDR2 of VL1) and a CDR3 which comprises the sequence of SEQ ID N °: 12 (CDR3 of VL1); e) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 13 (CDR1 of VL3), a CDR2 comprising the sequence of SEQ ID N °: 14 (CDR2 of VL3) and a CDR3 comprising the sequence of SEQ ID N °: 15 (CDR3 of VL3); and (f) a polypeptide comprising a CDR1 comprising the sequence of SEQ ID N °: 16 (CDR1 of VL5), a CDR2 comprising the sequence of SEQ ID N °: 17 (CDR2 of VL5) and a CDR3 comprising the sequence of SEQ ID N °: 18 (CDR3 of VL5). Claim 5: A stable pharmaceutical formulation according to any one of claims 1 to 4, characterized in that it comprises 1-500 mM of histidine and / or citrate buffering agent, 1-1500 mM of at least one cationic amino acid, 1-200 mg / mL of antibody, and 1-400 mM of a carbohydrate. Claim 12: The formulation according to any one of claims 1 to 11, characterized in that it contains the polypeptide and / or antibody in an amount less than or equal to 240 mg / ml. Claim 15: The formulation according to any of claims 1 to 14, characterized in that the formulation is liquid. Claim 16: The formulation according to claim 15, characterized in that it was not subjected to lyophilization during the preparation thereof.

ARP100100904A 2009-03-19 2010-03-19 PHARMACEUTICAL FORMULATION CONTAINING IMPROVED ANTIBODY MOLECULES, POLYPEPTIDES. METHOD FOR STABILIZING SOLUTION, ANTIBODY. AR075908A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2009069095 2009-03-19

Publications (1)

Publication Number Publication Date
AR075908A1 true AR075908A1 (en) 2011-05-04

Family

ID=42739479

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100100904A AR075908A1 (en) 2009-03-19 2010-03-19 PHARMACEUTICAL FORMULATION CONTAINING IMPROVED ANTIBODY MOLECULES, POLYPEPTIDES. METHOD FOR STABILIZING SOLUTION, ANTIBODY.

Country Status (8)

Country Link
JP (2) JP4885308B2 (en)
KR (1) KR101468271B1 (en)
AR (1) AR075908A1 (en)
AU (1) AU2010225951B2 (en)
RU (1) RU2565809C2 (en)
SG (3) SG174428A1 (en)
TW (1) TWI440470B (en)
WO (1) WO2010106812A1 (en)

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