MX363226B - Formulaciones de anticuerpos. - Google Patents

Formulaciones de anticuerpos.

Info

Publication number
MX363226B
MX363226B MX2014004992A MX2014004992A MX363226B MX 363226 B MX363226 B MX 363226B MX 2014004992 A MX2014004992 A MX 2014004992A MX 2014004992 A MX2014004992 A MX 2014004992A MX 363226 B MX363226 B MX 363226B
Authority
MX
Mexico
Prior art keywords
antibody formulations
formulations
antibody
methods
including pharmaceutical
Prior art date
Application number
MX2014004992A
Other languages
English (en)
Other versions
MX2014004992A (es
Inventor
Ajay Deshmukh
Joumana Zeid
M Scherer Thomas
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 MX2014004992A publication Critical patent/MX2014004992A/es
Publication of MX363226B publication Critical patent/MX363226B/es

Links

Classifications

    • 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
    • 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

Abstract

La presente invención se refiere a una formulación que comprende un anticuerpo anti-IL13 en una tampón de acetato de histidina, Ph DE 5.4 A 6.0, en donde la formulación no comprende arginina, en donde la concentración de anticuerpo en la formulación es de al menos de 100 mg/Ml y la viscosidad de la formulación es inferior a 15 centipoise (Cp) A 25°c, y en donde (i) el anticuerpo anti-IL13 comprende: a. una cadena pesada que tiene la secuencia de aminoácidos de SEQ ID NO: 10 y una cadena ligera que tiene tres CDRs de cadena ligera, CDR-L1 que tiene la secuencia de aminoácido de SEQ ID NO: 4, CDR-L2 que tiene la secuencia de aminoácidos de SEQ ID NO: 5, y CDR-L3 que tiene la secuencia de aminoácidos de SEQ ID NO: 6, b. una cadena ligera que tiene la secuencia de aminoácidos de SEQ ID NO: 14 y una cadena pesada que tiene tres CDRs de cadena pesada, CDR-H1 que tiene la secuencia de aminoácidos de SEQ ID NO: 1, CDR-H2 que tiene la secuencia de aminoácidos de SEQ ID NO: 2, y CDR-H3 que tiene la secuencia de aminoácidos de SEQ ID NO: 3; o c. una cadena pesada que tiene la secuencia de aminoácidos de SEQ ID NO: 10 y una cadena ligera que tiene la secuencia de aminoácidos de SEQ ID NO: 14, y (ii) la concentración de acetato de histidina en el tampón es de entre 5 Mm y 40 Mm.
MX2014004992A 2011-10-31 2012-10-30 Formulaciones de anticuerpos. MX363226B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161553916P 2011-10-31 2011-10-31
PCT/US2012/062572 WO2013066866A1 (en) 2011-10-31 2012-10-30 Antibody formulations

Publications (2)

Publication Number Publication Date
MX2014004992A MX2014004992A (es) 2014-08-27
MX363226B true MX363226B (es) 2019-03-15

Family

ID=48192677

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2014004992A MX363226B (es) 2011-10-31 2012-10-30 Formulaciones de anticuerpos.
MX2019002979A MX2019002979A (es) 2011-10-31 2014-04-24 Formulaciones de anticuerpos.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2019002979A MX2019002979A (es) 2011-10-31 2014-04-24 Formulaciones de anticuerpos.

Country Status (27)

Country Link
US (3) US10000562B2 (es)
EP (3) EP3091029B1 (es)
JP (4) JP6120452B2 (es)
KR (4) KR20140084078A (es)
CN (4) CN108704132A (es)
AR (2) AR088579A1 (es)
AU (3) AU2012332767C1 (es)
BR (1) BR112014008864B1 (es)
CA (2) CA2849210C (es)
DK (1) DK3091029T3 (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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Also Published As

Publication number Publication date
FI3091029T3 (fi) 2023-03-20
SI3091029T1 (sl) 2023-03-31
IL276234B (en) 2022-04-01
US20190002552A1 (en) 2019-01-03
MX2019002979A (es) 2020-02-10
WO2013066866A1 (en) 2013-05-10
RU2665810C2 (ru) 2018-09-04
CN109078182B (zh) 2022-08-12
US20210155684A1 (en) 2021-05-27
JP2014532664A (ja) 2014-12-08
KR102259829B1 (ko) 2021-06-03
IL232053A0 (en) 2014-05-28
AU2018232943B2 (en) 2020-07-23
CA3078979C (en) 2022-10-11
JP2019203002A (ja) 2019-11-28
EP3091029A1 (en) 2016-11-09
MY197851A (en) 2023-07-20
CN116077644A (zh) 2023-05-09
BR112014008864A2 (pt) 2018-08-07
MY187874A (en) 2021-10-26
US10947307B2 (en) 2021-03-16
CA3078979A1 (en) 2013-05-10
SG11201401903PA (en) 2014-05-29
ZA201901490B (en) 2021-06-30
AU2012332767C1 (en) 2017-02-02
PT3091029T (pt) 2023-02-03
KR20200065104A (ko) 2020-06-08
RU2014116070A (ru) 2015-12-10
BR112014008864B1 (pt) 2021-11-09
EP3091029B1 (en) 2022-12-28
CN108704132A (zh) 2018-10-26
AU2016210757A1 (en) 2016-08-25
US10000562B2 (en) 2018-06-19
HK1201857A1 (en) 2015-09-11
CA2849210A1 (en) 2013-05-10
AU2012332767B2 (en) 2016-05-12
KR20170096212A (ko) 2017-08-23
RS63948B1 (sr) 2023-02-28
JP6921148B2 (ja) 2021-08-18
AU2012332767A1 (en) 2014-04-10
KR20140084078A (ko) 2014-07-04
PL3091029T3 (pl) 2023-04-11
HUE061728T2 (hu) 2023-08-28
ES2936387T3 (es) 2023-03-16
US20140348855A1 (en) 2014-11-27
IL276234A (en) 2020-09-30
CN104039826A (zh) 2014-09-10
EP2773662A4 (en) 2015-07-01
EP2773662A1 (en) 2014-09-10
DK3091029T3 (da) 2023-01-30
EP4218937A2 (en) 2023-08-02
KR101994809B1 (ko) 2019-07-01
JP6120452B2 (ja) 2017-04-26
EP4218937A3 (en) 2023-10-25
IL232053B (en) 2020-08-31
ZA201401779B (en) 2019-07-31
MX2014004992A (es) 2014-08-27
CA2849210C (en) 2020-07-14
HRP20230153T1 (hr) 2023-03-31
AR124140A2 (es) 2023-02-15
KR20190077127A (ko) 2019-07-02
AU2018232943A1 (en) 2018-10-11
JP2016193922A (ja) 2016-11-17
AR088579A1 (es) 2014-06-18
JP6272950B2 (ja) 2018-01-31
CN109078182A (zh) 2018-12-25
LT3091029T (lt) 2023-02-27
NZ622654A (en) 2017-01-27
JP2018048166A (ja) 2018-03-29

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