AR092388A1 - Formulaciones de anticuerpo y proteina - Google Patents

Formulaciones de anticuerpo y proteina

Info

Publication number
AR092388A1
AR092388A1 ARP130103085A ARP130103085A AR092388A1 AR 092388 A1 AR092388 A1 AR 092388A1 AR P130103085 A ARP130103085 A AR P130103085A AR P130103085 A ARP130103085 A AR P130103085A AR 092388 A1 AR092388 A1 AR 092388A1
Authority
AR
Argentina
Prior art keywords
antibody
protein
antibody formulation
salt
ppm
Prior art date
Application number
ARP130103085A
Other languages
English (en)
Inventor
Ma Xinghang
Xiang Jun
Original Assignee
Bayer Healthcare Llc
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
Priority claimed from US13/601,598 external-priority patent/US8613919B1/en
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of AR092388A1 publication Critical patent/AR092388A1/es

Links

Classifications

    • 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
    • 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
    • A61K47/16—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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/38—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against protease inhibitors of peptide structure
    • 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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

Reivindicación 1: Una formulación de proteína o anticuerpo libre de sal, caracterizada porque comprende: a) 10 mM a 30 mM histidina; b) 50 ppm a 200 ppm de un surfactante no iónico; c) 88 mM a 292 mM de una azúcar o azúcar alcohólica seleccionada desde manitol, dextrosa, glucosa, trehalosa y sacarosa; d) 0 mM a 50 mM arginina; e) 0 mM a 50 mM lisina; f) 0 mM a 133 mM glicina o alanina; g) 0 mM a 10 mM metionina; y h) 1 mg/ml a 150 mg/ml de una proteína o un anticuerpo; donde dicha formulación de proteína o anticuerpo tiene un rango de pH desde pH 4,0 a pH 6,0 y donde dicha formulación de proteína sustancialmente no contiene sal inorgánica. Reivindicación 4: La formulación de proteína o anticuerpo libre de sal de la reivindicación 1, caracterizada porque dicho surfactante no iónico es un polisorbato seleccionado desde polisorbato 20 y polisorbato 80. Reivindicación 17: Una formulación de anticuerpo anti-TFPI libre de sal, caracterizada porque comprende: a) 10 mM a 30 mM histidina, b) 50 ppm a 200 ppm de un surfactante no iónico, c) 88 mM a 292 mM de una azúcar o azúcar alcohólica seleccionada desde manitol, dextrosa, glucosa, trehalosa y sacarosa, d) 0 mM a 50 mM arginina, e) 0 mM a 50 mM lisina, f) 0 mM a133 mM glicina o alanita, g) 0 mM a 10 mM metionina, y h) 1 mg/ml a 150 mg/ml de anticuerpo anti-TFPI; donde dicha formulación de anticuerpo anti-TFPI tiene un pH en el rango de pH 4.0 a pH 6,0 y donde dicha formulación de anticuerpo anti-TPFI sustancialmente no contiene sal inorgánica. Reivindicación 23: La formulación de anticuerpo anti-TFPI libre de sal de la reivindicación 17, caracterizada porque dicho anticuerpo anti-TFPI es un anticuerpo monoclonal IgG₂ humano. Reivindicación 24: La formulación de anticuerpo anti-TFPI libre de sal de la reivindicación 17, caracterizada porque dicho anticuerpo monoclonal IgG₂ humano comprende una cadena liviana que comprende la secuencia de aminoácidos SEQ ID Nº 1 y una cadena pesada que comprende la secuencia de aminoácidos de SEQ ID Nº 2. Reivindicación 25: Un método para el tratamiento de un desorden en un paciente, caracterizado porque dicho método comprende administrar a dicho paciente una cantidad terapéuticamente efectiva de una formulación de proteína o anticuerpo que comprende entre 10 mM y 30 mM histidina, entre 50 ppm y 200 ppm polisorbato 80 o polisorbato 20, entre 88 mM y 292 mM sacarosa, entre 0mM y 50 mM arginina, entre 0 mM y 50 mM lisina, entre 0 mM y 133 mM glicina, entre 0 mM y 10 mM metionina, y entre 1mg/ml y 150mg/ml de una proteína o anticuerpo a un pH de entre pH 4,0 y pH 6,0, donde dicha formulación de proteína o anticuerpo sustancialmente no contiene sal inorgánica. Reivindicación 30: El método de la reivindicación 27, caracterizado porque dicha formulación de anticuerpo anti-TFPI se administra intravenosamente, intramuscularmente, o subcutáneamente.
ARP130103085A 2012-08-31 2013-08-29 Formulaciones de anticuerpo y proteina AR092388A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/601,598 US8613919B1 (en) 2012-08-31 2012-08-31 High concentration antibody and protein formulations
US13/843,780 US9592297B2 (en) 2012-08-31 2013-03-15 Antibody and protein formulations

Publications (1)

Publication Number Publication Date
AR092388A1 true AR092388A1 (es) 2015-04-22

Family

ID=49162239

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP130103085A AR092388A1 (es) 2012-08-31 2013-08-29 Formulaciones de anticuerpo y proteina
ARP130103099A AR092400A1 (es) 2012-08-31 2013-08-30 Formulaciones de anticuerpos y proteinas de alta concentracion

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP130103099A AR092400A1 (es) 2012-08-31 2013-08-30 Formulaciones de anticuerpos y proteinas de alta concentracion

Country Status (26)

Country Link
US (7) US9592297B2 (es)
EP (3) EP3117837B1 (es)
JP (3) JP6462567B2 (es)
CN (2) CN104684933B (es)
AR (2) AR092388A1 (es)
AU (3) AU2013308902B2 (es)
BR (1) BR112015003838A2 (es)
CA (2) CA3129277A1 (es)
CY (1) CY1121989T1 (es)
DK (1) DK3117837T3 (es)
ES (1) ES2741575T3 (es)
HK (1) HK1210794A1 (es)
HR (1) HRP20191299T1 (es)
HU (1) HUE045652T2 (es)
IL (6) IL294567A (es)
LT (1) LT3117837T (es)
MX (2) MX369653B (es)
PL (1) PL3117837T3 (es)
PT (1) PT3117837T (es)
RS (1) RS59221B1 (es)
RU (2) RU2678097C2 (es)
SG (2) SG10201708215YA (es)
SI (1) SI3117837T1 (es)
TW (4) TW201927338A (es)
UY (1) UY34995A (es)
WO (1) WO2014036071A1 (es)

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