AR091413A1 - Formulacion de anticuerpos - Google Patents

Formulacion de anticuerpos

Info

Publication number
AR091413A1
AR091413A1 ARP130102057A AR091413A1 AR 091413 A1 AR091413 A1 AR 091413A1 AR P130102057 A ARP130102057 A AR P130102057A AR 091413 A1 AR091413 A1 AR 091413A1
Authority
AR
Argentina
Prior art keywords
aqueous composition
antibody
composition according
delivery device
filled syringe
Prior art date
Application number
Other languages
English (en)
Inventor
Cosenza Marta
Stark Christoph
Original Assignee
Novartis Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48914378&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR091413(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of AR091413A1 publication Critical patent/AR091413A1/es

Links

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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/06Organic 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
    • 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
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • 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
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • 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
    • 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
    • C07K2317/70Immunoglobulins 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

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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Los anticuerpos anti-BAFFR se formulan como formulación líquida que comprende una alta concentración del ingrediente activo de anticuerpo para la entrega en un paciente sin altos niveles de agregación de anticuerpos. La composición farmacéutica acuosa puede incluir uno o más azúcares, un agente amortiguador, un surfactante, y/o un aminoácido libre. Reivindicación 2: La composición acuosa de la reivindicación 1 que tiene un pH de 5.5 - 6.5 y que comprende (i) un anticuerpo anti-BAFFR en el que el anticuerpo tiene una concentración de 18 a -165 mg/ml, y en el que dicho anticuerpo anti-BAFFR incluye CDR1, CDR2 y CDR3 de cadena pesada de SEC ID Nº 3, 4 y 5, respectivamente, y CDR1, CDR2 y CDR3 de cadena ligera de SEC ID Nº 6, 7 y 8, (ii) sacarosa, trehalosa o manitol como un estabilizador, (iii) histidina, citrato o succinato como un agente amortiguador, (iv) polisorbato 20, poloxámero 188 o hidroxipropil-b-ciclodextrina como un surfactante, y, opcionalmente, (v) arginina como un aminoácido. Reivindicación 25: Un dispositivo de suministro que comprende la composición acuosa de acuerdo con una cualquiera de las reivindicaciones 1 - 24. Reivindicación 26: Un jeringa pre-cargada que comprende la composición acuosa de acuerdo con una cualquiera de las reivindicaciones 1 - 24. Reivindicación 30: La composición acuosa según una cualquiera de las reivindicaciones 1 - 24, o el dispositivo de administración de la reivindicación 25, o la jeringa pre-cargada de la reivindicación 26, para su utilizar en el tratamiento de un neoplasma de células B, tal como linfoma, leucemia o mieloma. Reivindicación 31: La composición acuosa según una cualquiera de las reivindicaciones 1 - 24, o el dispositivo de administración de la reivindicación 25, o la jeringa pre-cargada de la reivindicación 26, para su utilizar en el tratamiento de artritis reumatoide, lupus eritematoso sistémico, síndrome de Sjögren, o pénfigo vulgar.
ARP130102057 2012-06-12 2013-06-12 Formulacion de anticuerpos AR091413A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201261658472P 2012-06-12 2012-06-12

Publications (1)

Publication Number Publication Date
AR091413A1 true AR091413A1 (es) 2015-02-04

Family

ID=48914378

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130102057 AR091413A1 (es) 2012-06-12 2013-06-12 Formulacion de anticuerpos

Country Status (36)

Country Link
US (4) US9216219B2 (es)
EP (2) EP2858671B1 (es)
JP (1) JP6265978B2 (es)
KR (1) KR102124820B1 (es)
CN (1) CN104363920B (es)
AR (1) AR091413A1 (es)
AU (1) AU2013276112B2 (es)
BR (1) BR112014030820B1 (es)
CA (1) CA2875386C (es)
CL (1) CL2014003370A1 (es)
CO (1) CO7151487A2 (es)
CY (1) CY1122181T1 (es)
DK (1) DK2858671T3 (es)
EA (1) EA033373B1 (es)
EC (1) ECSP15017314A (es)
ES (1) ES2751659T3 (es)
GT (1) GT201400285A (es)
HK (1) HK1203146A1 (es)
HR (1) HRP20191827T1 (es)
HU (1) HUE045523T2 (es)
IL (1) IL235966B (es)
LT (1) LT2858671T (es)
MA (1) MA37616A1 (es)
MX (1) MX363380B (es)
MY (1) MY179818A (es)
NZ (1) NZ630885A (es)
PE (1) PE20150200A1 (es)
PH (1) PH12014502778A1 (es)
PL (1) PL2858671T3 (es)
PT (1) PT2858671T (es)
SG (1) SG11201408174UA (es)
SI (1) SI2858671T1 (es)
TN (1) TN2014000488A1 (es)
TW (1) TWI653983B (es)
WO (1) WO2013186700A1 (es)
ZA (1) ZA201408547B (es)

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Also Published As

Publication number Publication date
KR102124820B1 (ko) 2020-06-22
WO2013186700A1 (en) 2013-12-19
US9216219B2 (en) 2015-12-22
US20130344088A1 (en) 2013-12-26
CN104363920A (zh) 2015-02-18
SG11201408174UA (en) 2015-01-29
US20180051092A1 (en) 2018-02-22
SI2858671T1 (sl) 2019-11-29
CA2875386A1 (en) 2013-12-19
US9751951B2 (en) 2017-09-05
JP2015521593A (ja) 2015-07-30
HRP20191827T1 (hr) 2019-12-27
BR112014030820A2 (pt) 2017-07-25
ES2751659T3 (es) 2020-04-01
NZ630885A (en) 2016-01-29
CY1122181T1 (el) 2020-11-25
MY179818A (en) 2020-11-16
TW201402144A (zh) 2014-01-16
TWI653983B (zh) 2019-03-21
CL2014003370A1 (es) 2015-02-06
EP2858671B1 (en) 2019-07-24
KR20150029683A (ko) 2015-03-18
PH12014502778B1 (en) 2015-02-02
AU2013276112B2 (en) 2015-07-09
BR112014030820B1 (pt) 2023-02-07
CA2875386C (en) 2022-09-13
CO7151487A2 (es) 2014-12-29
MX363380B (es) 2019-03-21
DK2858671T3 (da) 2019-10-21
JP6265978B2 (ja) 2018-01-24
EA033373B1 (ru) 2019-10-31
HK1203146A1 (en) 2015-10-23
US10689451B2 (en) 2020-06-23
CN104363920B (zh) 2018-05-04
MX2014015262A (es) 2015-06-23
US20180251564A1 (en) 2018-09-06
AU2013276112A1 (en) 2014-12-18
EP2858671A1 (en) 2015-04-15
GT201400285A (es) 2015-10-15
ECSP15017314A (es) 2018-06-30
IL235966B (en) 2020-05-31
EA201492292A1 (ru) 2015-04-30
HUE045523T2 (hu) 2020-01-28
TN2014000488A1 (en) 2016-03-30
PT2858671T (pt) 2019-10-28
PH12014502778A1 (en) 2015-02-02
PE20150200A1 (es) 2015-02-08
LT2858671T (lt) 2019-10-25
ZA201408547B (en) 2015-12-23
MA37616A1 (fr) 2017-08-31
US20160145341A1 (en) 2016-05-26
EP3593814A1 (en) 2020-01-15
IL235966A0 (en) 2015-01-29
PL2858671T3 (pl) 2020-01-31

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