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AR088579A1 - Formulaciones de anticuerpos - Google Patents

Formulaciones de anticuerpos

Info

Publication number
AR088579A1
AR088579A1 ARP120104056A AR088579A1 AR 088579 A1 AR088579 A1 AR 088579A1 AR P120104056 A ARP120104056 A AR P120104056A AR 088579 A1 AR088579 A1 AR 088579A1
Authority
AR
Argentina
Prior art keywords
formulation
cdr
seq
amino acid
acid sequence
Prior art date
Application number
Other languages
English (en)
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of AR088579A1 publication Critical patent/AR088579A1/es

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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]
    • 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
    • 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • 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
    • 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
    • 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
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Se proporcionan formulaciones que comprenden un anticuerpo anti-IL-1 3, incluyendo formulaciones farmacéuticas y métodos de uso de dichas formulaciones. Reivindicación 1: Una formulación que comprende un anticuerpo anti-IL13, en donde la concentración de anticuerpo en la formulación es de al menos 100 mg/mL y la viscosidad de la formulación es inferior a 15 centipoise (cP) a 25ºC. Reivindicación 2: La formulación de acuerdo con la reivindicación 1, en donde el anticuerpo anti-IL13 comprende tres CDR de cadena pesada, donde CDR-H1 tiene la secuencia de aminoácidos de SEQ ID Nº 1, CDR-H2 tiene la secuencia de aminoácidos de SEQ ID Nº 2 y CDR-H3 tiene la secuencia de aminoácidos de SEQ ID Nº 3 y tres CDR de cadena liviana, donde CDR-L1 tiene la secuencia de aminoácidos de SEQ ID Nº 4, CDR-L2 tiene la secuencia de aminoácidos de SEQ ID Nº 5 y CDR-L3 tiene la secuencia de aminoácidos de SEQ ID Nº 6. Reivindicación 11: La formulación de acuerdo con la reivindicación 1 que comprende tampón de acetato de histidina, pH 5,4 a 6,0, en donde la concentración de acetato de histidina en el tampón es de entre 5 mM y 40 mM. Reivindicación 12: La formulación de acuerdo con la reivindicación 11, que también comprende un poliol y un tensioactivo, en donde la concentración del poliol en la formulación es de entre 100 mM y 200 mM y la concentración del tensioactivo en la formulación es de entre el 0,01% y el 0,1%. Reivindicación 13: La formulación de acuerdo con la reivindicación 12, en donde el poliol es sacarosa y el tensioactivo es polisorbato 20.
ARP120104056 2011-10-31 2012-10-30 Formulaciones de anticuerpos AR088579A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201161553916P 2011-10-31 2011-10-31

Publications (1)

Publication Number Publication Date
AR088579A1 true AR088579A1 (es) 2014-06-18

Family

ID=48192677

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP120104056 AR088579A1 (es) 2011-10-31 2012-10-30 Formulaciones de anticuerpos
ARP210103246A AR124140A2 (es) 2011-10-31 2021-11-24 Formulaciones de anticuerpos

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP210103246A AR124140A2 (es) 2011-10-31 2021-11-24 Formulaciones de anticuerpos

Country Status (27)

Country Link
US (3) US10000562B2 (es)
EP (3) EP3091029B1 (es)
JP (4) JP6120452B2 (es)
KR (4) KR102259829B1 (es)
CN (4) CN116077644A (es)
AR (2) AR088579A1 (es)
AU (3) AU2012332767C1 (es)
BR (1) BR112014008864B1 (es)
CA (2) CA3078979C (es)
DK (1) DK3091029T5 (es)
ES (1) ES2936387T3 (es)
FI (1) FI3091029T3 (es)
HK (1) HK1201857A1 (es)
HR (1) HRP20230153T1 (es)
HU (1) HUE061728T2 (es)
IL (2) IL232053B (es)
LT (1) LT3091029T (es)
MX (2) MX363226B (es)
MY (2) MY197851A (es)
PL (1) PL3091029T3 (es)
PT (1) PT3091029T (es)
RS (1) RS63948B1 (es)
RU (1) RU2665810C2 (es)
SG (1) SG11201401903PA (es)
SI (1) SI3091029T1 (es)
WO (1) WO2013066866A1 (es)
ZA (2) ZA201401779B (es)

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