LT3212667T - Farmacinė anti-tnf-alfa antikūnų kompozicija - Google Patents

Farmacinė anti-tnf-alfa antikūnų kompozicija

Info

Publication number
LT3212667T
LT3212667T LTEP15808356.8T LT15808356T LT3212667T LT 3212667 T LT3212667 T LT 3212667T LT 15808356 T LT15808356 T LT 15808356T LT 3212667 T LT3212667 T LT 3212667T
Authority
LT
Lithuania
Prior art keywords
tnf
antibody formulation
alpha antibody
pharmaceutical anti
pharmaceutical
Prior art date
Application number
LTEP15808356.8T
Other languages
English (en)
Inventor
Jozsef Lazar
Marcell OLAJOS
Varga-Kugler JANOS
Original Assignee
Richter Gedeon Nyrt.
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 Richter Gedeon Nyrt. filed Critical Richter Gedeon Nyrt.
Publication of LT3212667T publication Critical patent/LT3212667T/lt

Links

Classifications

    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • 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
    • C07K16/241Tumor Necrosis Factors
    • 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
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
LTEP15808356.8T 2014-10-28 2015-10-28 Farmacinė anti-tnf-alfa antikūnų kompozicija LT3212667T (lt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény
PCT/EP2015/074986 WO2016066688A1 (en) 2014-10-28 2015-10-28 Pharmaceutical anti-tnf-alpha antibody formulation

Publications (1)

Publication Number Publication Date
LT3212667T true LT3212667T (lt) 2018-12-10

Family

ID=89991627

Family Applications (1)

Application Number Title Priority Date Filing Date
LTEP15808356.8T LT3212667T (lt) 2014-10-28 2015-10-28 Farmacinė anti-tnf-alfa antikūnų kompozicija

Country Status (18)

Country Link
US (2) US20170252437A1 (lt)
EP (2) EP3428189A1 (lt)
BR (1) BR112017009021A2 (lt)
CA (1) CA2989930A1 (lt)
CY (1) CY1120937T1 (lt)
DE (4) DE202015009016U1 (lt)
DK (1) DK3212667T3 (lt)
ES (1) ES2703586T3 (lt)
HR (1) HRP20182006T1 (lt)
HU (2) HUP1400510A1 (lt)
LT (1) LT3212667T (lt)
MX (1) MX2017005575A (lt)
PL (1) PL3212667T3 (lt)
PT (1) PT3212667T (lt)
RS (1) RS58172B1 (lt)
SI (1) SI3212667T1 (lt)
TR (1) TR201816518T4 (lt)
WO (1) WO2016066688A1 (lt)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2926588C (en) 2013-10-16 2020-07-21 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
EP3247718B1 (en) 2015-01-21 2021-09-01 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
CA3013336A1 (en) * 2016-02-03 2017-08-10 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
PT3479819T (pt) * 2016-06-30 2024-04-15 Celltrion Inc Preparação farmacêutica líquida estável
HUP1600456A2 (en) 2016-07-19 2018-01-29 Richter Gedeon Nyrt Novel cell-based tnf-alpha binding assay
WO2018119142A1 (en) * 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
RU2764521C2 (ru) * 2017-12-29 2022-01-18 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОа
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372242A1 (en) * 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
UA123847C2 (uk) * 2017-03-16 2021-06-09 Лг Кем, Лтд. Рідка композиція анти-tnf альфа антитіла
WO2018184693A1 (en) * 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184692A1 (en) * 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
MX2021003329A (es) * 2018-09-20 2021-06-08 Teva Pharmaceuticals Int Gmbh Resorte de inyección para jeringa precargada desgastada e inyector automático.
AU2020207124A1 (en) * 2019-01-11 2021-07-29 Samsung Bioepis Co., Ltd. Pharmaceutical composition comprising antibody, device comprising same, and use thereof
US20230115267A1 (en) * 2020-03-13 2023-04-13 Samsung Bioepis Co., Ltd. Pharmaceutical liquid composition having increased stability
DE102020129648A1 (de) * 2020-11-10 2022-05-12 Leopold MTX GmbH Pharmazeutische zusammensetzung
WO2023147426A2 (en) * 2022-01-27 2023-08-03 Janssen Biotech, Inc. Enhanced protein compositions

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5945098A (en) 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
US6090382A (en) 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
NZ512006A (en) 1996-02-09 2005-05-27 Abbott Biotech Ltd Medical treatment with human TNF-alpha antibodies
FI20021199A (fi) 2002-06-19 2003-12-20 Kemira Growhow Oy Menetelmä tuotantoa rajoittavien paikkakohtaisten kasvutekijöiden analysoimiseksi
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
BR112012021576A2 (pt) * 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.
EP2471554A1 (en) 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
GB201112429D0 (en) * 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
BR112014017882A2 (pt) * 2012-01-23 2017-06-27 Regeneron Pharma formulações estabilizadas contendo anticorpos anti-ang-2
TR201810815T4 (tr) 2012-03-07 2018-08-27 Cadila Healthcare Ltd Tnf-alfa antikorlarının farmasötik formülasyonları.
US20150150982A1 (en) 2012-06-12 2015-06-04 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
EA029215B1 (ru) 2012-09-07 2018-02-28 Кохерус Байосайенсис, Инк. Стабильные водные составы адалимумаба
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
CN105051064A (zh) 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény

Also Published As

Publication number Publication date
DE18190279T1 (de) 2019-07-11
DK3212667T3 (en) 2018-12-03
DE202015009509U1 (de) 2018-01-18
PT3212667T (pt) 2018-12-20
MX2017005575A (es) 2017-09-01
EP3212667A1 (en) 2017-09-06
HUP1400510A1 (hu) 2016-05-30
ES2703586T3 (es) 2019-03-11
DE202015009509U9 (de) 2018-05-30
PL3212667T3 (pl) 2019-02-28
HRP20182006T1 (hr) 2019-01-25
CA2989930A1 (en) 2016-05-06
TR201816518T4 (tr) 2018-11-21
US20220016244A1 (en) 2022-01-20
DE202015009619U1 (de) 2018-08-29
WO2016066688A1 (en) 2016-05-06
DE202015009016U1 (de) 2016-06-24
SI3212667T1 (sl) 2018-11-30
EP3212667B1 (en) 2018-09-19
RS58172B1 (sr) 2019-03-29
BR112017009021A2 (pt) 2018-02-06
CY1120937T1 (el) 2019-12-11
US20170252437A1 (en) 2017-09-07
EP3428189A1 (en) 2019-01-16
HUE040621T2 (hu) 2019-03-28

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