CY1122181T1 - Φαρμακοτεχνικη μορφη αντισωματος - Google Patents

Φαρμακοτεχνικη μορφη αντισωματος

Info

Publication number
CY1122181T1
CY1122181T1 CY20191101096T CY191101096T CY1122181T1 CY 1122181 T1 CY1122181 T1 CY 1122181T1 CY 20191101096 T CY20191101096 T CY 20191101096T CY 191101096 T CY191101096 T CY 191101096T CY 1122181 T1 CY1122181 T1 CY 1122181T1
Authority
CY
Cyprus
Prior art keywords
antibody
pharmaceutical form
sugars
formulated
surfactant
Prior art date
Application number
CY20191101096T
Other languages
English (en)
Inventor
Marta Cosenza
Christoph Stark
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1122181(T1) "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 CY1122181T1 publication Critical patent/CY1122181T1/el

Links

Classifications

    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [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
    • 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
    • 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
    • A61K47/26—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
    • A61K9/0012—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

Τα αντισώματα αντι-BAFFR τυποποιούνται ως υγρή φαρμακοτεχνική μορφή που περιλαμβάνει υψηλή συγκέντρωση του δραστικού συστατικού αντισώματος για χορήγηση σε έναν ασθενή χωρίς υψηλά επίπεδα συσσωμάτωσης του αντισώματος. Η υδατική φαρμακευτική σύνθεση μπορεί να περιλαμβάνει ένα ή περισσότερα σάκχαρα, ένα ρυθμιστικό παράγοντα, ένα επιφανειοδραστικό μέσο ή/και ένα ελεύθερο αμινοξύ.
CY20191101096T 2012-06-12 2019-10-22 Φαρμακοτεχνικη μορφη αντισωματος CY1122181T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261658472P 2012-06-12 2012-06-12
PCT/IB2013/054777 WO2013186700A1 (en) 2012-06-12 2013-06-11 Antibody formulation

Publications (1)

Publication Number Publication Date
CY1122181T1 true CY1122181T1 (el) 2020-11-25

Family

ID=48914378

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191101096T CY1122181T1 (el) 2012-06-12 2019-10-22 Φαρμακοτεχνικη μορφη αντισωματος

Country Status (36)

Country Link
US (4) US9216219B2 (el)
EP (2) EP2858671B1 (el)
JP (1) JP6265978B2 (el)
KR (1) KR102124820B1 (el)
CN (1) CN104363920B (el)
AR (1) AR091413A1 (el)
AU (1) AU2013276112B2 (el)
BR (1) BR112014030820B1 (el)
CA (1) CA2875386C (el)
CL (1) CL2014003370A1 (el)
CO (1) CO7151487A2 (el)
CY (1) CY1122181T1 (el)
DK (1) DK2858671T3 (el)
EA (1) EA033373B1 (el)
EC (1) ECSP15017314A (el)
ES (1) ES2751659T3 (el)
GT (1) GT201400285A (el)
HK (1) HK1203146A1 (el)
HR (1) HRP20191827T1 (el)
HU (1) HUE045523T2 (el)
IL (1) IL235966B (el)
LT (1) LT2858671T (el)
MA (1) MA37616A1 (el)
MX (1) MX363380B (el)
MY (1) MY179818A (el)
NZ (1) NZ630885A (el)
PE (1) PE20150200A1 (el)
PH (1) PH12014502778B1 (el)
PL (1) PL2858671T3 (el)
PT (1) PT2858671T (el)
SG (1) SG11201408174UA (el)
SI (1) SI2858671T1 (el)
TN (1) TN2014000488A1 (el)
TW (1) TWI653983B (el)
WO (1) WO2013186700A1 (el)
ZA (1) ZA201408547B (el)

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Also Published As

Publication number Publication date
KR20150029683A (ko) 2015-03-18
IL235966B (en) 2020-05-31
CO7151487A2 (es) 2014-12-29
EP3593814A1 (en) 2020-01-15
ECSP15017314A (es) 2018-06-30
SI2858671T1 (sl) 2019-11-29
US9216219B2 (en) 2015-12-22
DK2858671T3 (da) 2019-10-21
US9751951B2 (en) 2017-09-05
PE20150200A1 (es) 2015-02-08
MX2014015262A (es) 2015-06-23
US20180251564A1 (en) 2018-09-06
JP2015521593A (ja) 2015-07-30
CL2014003370A1 (es) 2015-02-06
TW201402144A (zh) 2014-01-16
TWI653983B (zh) 2019-03-21
MA37616A1 (fr) 2017-08-31
IL235966A0 (en) 2015-01-29
GT201400285A (es) 2015-10-15
PL2858671T3 (pl) 2020-01-31
TN2014000488A1 (en) 2016-03-30
AU2013276112A1 (en) 2014-12-18
PT2858671T (pt) 2019-10-28
PH12014502778A1 (en) 2015-02-02
CA2875386C (en) 2022-09-13
US10689451B2 (en) 2020-06-23
CN104363920A (zh) 2015-02-18
MY179818A (en) 2020-11-16
EA201492292A1 (ru) 2015-04-30
BR112014030820A2 (pt) 2017-07-25
CA2875386A1 (en) 2013-12-19
AR091413A1 (es) 2015-02-04
NZ630885A (en) 2016-01-29
MX363380B (es) 2019-03-21
JP6265978B2 (ja) 2018-01-24
BR112014030820B1 (pt) 2023-02-07
US20130344088A1 (en) 2013-12-26
SG11201408174UA (en) 2015-01-29
CN104363920B (zh) 2018-05-04
LT2858671T (lt) 2019-10-25
WO2013186700A1 (en) 2013-12-19
EP2858671A1 (en) 2015-04-15
KR102124820B1 (ko) 2020-06-22
HK1203146A1 (en) 2015-10-23
EA033373B1 (ru) 2019-10-31
ZA201408547B (en) 2015-12-23
ES2751659T3 (es) 2020-04-01
HUE045523T2 (hu) 2020-01-28
HRP20191827T1 (hr) 2019-12-27
US20160145341A1 (en) 2016-05-26
AU2013276112B2 (en) 2015-07-09
US20180051092A1 (en) 2018-02-22
EP2858671B1 (en) 2019-07-24
PH12014502778B1 (en) 2015-02-02

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