AR075908A1 - Formulacion farmaceutica que contiene moleculas de anticuerpo mejoradas, polipeptidos. metodo para estabilizar solucion, anticuerpo. - Google Patents

Formulacion farmaceutica que contiene moleculas de anticuerpo mejoradas, polipeptidos. metodo para estabilizar solucion, anticuerpo.

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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
English (en)
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/es

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Classifications

    • 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
    • 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
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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
    • 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54F(ab')2
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72Increased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (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)
  • Rheumatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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.
ARP100100904A 2009-03-19 2010-03-19 Formulacion farmaceutica que contiene moleculas de anticuerpo mejoradas, polipeptidos. metodo para estabilizar solucion, anticuerpo. AR075908A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

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

Family

ID=42739479

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100100904A AR075908A1 (es) 2009-03-19 2010-03-19 Formulacion farmaceutica que contiene moleculas de anticuerpo mejoradas, polipeptidos. metodo para estabilizar solucion, anticuerpo.

Country Status (8)

Country Link
JP (2) JP4885308B2 (es)
KR (1) KR101468271B1 (es)
AR (1) AR075908A1 (es)
AU (1) AU2010225951B2 (es)
RU (1) RU2565809C2 (es)
SG (3) SG10201900451SA (es)
TW (1) TWI440470B (es)
WO (1) WO2010106812A1 (es)

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Also Published As

Publication number Publication date
RU2011142184A (ru) 2013-04-27
SG10201900451SA (en) 2019-02-27
TWI440470B (zh) 2014-06-11
JP4885308B2 (ja) 2012-02-29
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