HUE040621T2 - Gyógyászati TNFalfa ellenes antitest készítmény - Google Patents

Gyógyászati TNFalfa ellenes antitest készítmény

Info

Publication number
HUE040621T2
HUE040621T2 HUE15808356A HUE15808356A HUE040621T2 HU E040621 T2 HUE040621 T2 HU E040621T2 HU E15808356 A HUE15808356 A HU E15808356A HU E15808356 A HUE15808356 A HU E15808356A HU E040621 T2 HUE040621 T2 HU E040621T2
Authority
HU
Hungary
Prior art keywords
tnf
antibody formulation
alpha antibody
pharmaceutical anti
pharmaceutical
Prior art date
Application number
HUE15808356A
Other languages
English (en)
Inventor
Jozsef Lazar
Marcell Olajos
Janos Varga-Kugler
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 HUE040621T2 publication Critical patent/HUE040621T2/hu

Links

Classifications

    • 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
    • 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
    • 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)
HUE15808356A 2014-10-28 2015-10-28 Gyógyászati TNFalfa ellenes antitest készítmény HUE040621T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény

Publications (1)

Publication Number Publication Date
HUE040621T2 true HUE040621T2 (hu) 2019-03-28

Family

ID=89991627

Family Applications (2)

Application Number Title Priority Date Filing Date
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény
HUE15808356A HUE040621T2 (hu) 2014-10-28 2015-10-28 Gyógyászati TNFalfa ellenes antitest készítmény

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény

Country Status (18)

Country Link
US (2) US20170252437A1 (hu)
EP (2) EP3428189A1 (hu)
BR (1) BR112017009021A2 (hu)
CA (1) CA2989930A1 (hu)
CY (1) CY1120937T1 (hu)
DE (4) DE18190279T1 (hu)
DK (1) DK3212667T3 (hu)
ES (1) ES2703586T3 (hu)
HR (1) HRP20182006T1 (hu)
HU (2) HUP1400510A1 (hu)
LT (1) LT3212667T (hu)
MX (1) MX2017005575A (hu)
PL (1) PL3212667T3 (hu)
PT (1) PT3212667T (hu)
RS (1) RS58172B1 (hu)
SI (1) SI3212667T1 (hu)
TR (1) TR201816518T4 (hu)
WO (1) WO2016066688A1 (hu)

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
US10696735B2 (en) 2015-01-21 2020-06-30 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
MX2018009341A (es) * 2016-02-03 2019-05-15 Oncobiologics Inc Formulaciones tamponadas para una mayor estabilidad de anticuerpos.
CR20180599A (es) * 2016-06-30 2019-04-09 Celltrion Inc Preparación farmacéutica líquida estable
HUP1600456A2 (en) 2016-07-19 2018-01-29 Richter Gedeon Nyrt Novel cell-based tnf-alpha binding assay
EP3558363A1 (en) * 2016-12-21 2019-10-30 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
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372242A1 (en) * 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
KR20180106974A (ko) * 2017-03-16 2018-10-01 주식회사 엘지화학 항-tnf 알파 항체의 액상 제제
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
CA3113728A1 (en) * 2018-09-20 2020-03-26 Teva Pharmaceuticals International Gmbh Injection spring for aged prefilled syringe and auto injector
BR112021013497A2 (pt) * 2019-01-11 2021-09-14 Samsung Bioepis Co., Ltd. Composição farmacêutica compreendendo anticorpo, dispositivo compreendendo o mesmo e uso do mesmo
EP4119161A4 (en) * 2020-03-13 2024-05-15 Samsung Bioepis Co., Ltd. LIQUID PHARMACEUTICAL COMPOSITION WITH IMPROVED 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
SI9720020B (en) 1996-02-09 2001-12-31 Basf Ag Human antibodies that bind human TNF alpha
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
SI3409289T1 (sl) * 2010-02-26 2020-12-31 Novo Nordisk A/S Stabilni sestavki, ki vsebujejo protitelo
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
CN104169299B (zh) * 2012-01-23 2018-06-05 瑞泽恩制药公司 含抗Ang-2 抗体的稳定化制剂
AP2014007922A0 (en) 2012-03-07 2014-09-30 Cadila Healthcare Ltd Pharmaceutical formulations of TNF-alpha antibodies
US20150150982A1 (en) * 2012-06-12 2015-06-04 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
WO2014039903A2 (en) 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
KR20150110659A (ko) * 2013-01-24 2015-10-02 글락소스미스클라인 인털렉츄얼 프로퍼티 디벨로프먼트 리미티드 Tnf-알파 항원-결합 단백질
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény

Also Published As

Publication number Publication date
DE202015009016U1 (de) 2016-06-24
EP3428189A1 (en) 2019-01-16
MX2017005575A (es) 2017-09-01
US20220016244A1 (en) 2022-01-20
PL3212667T3 (pl) 2019-02-28
TR201816518T4 (tr) 2018-11-21
US20170252437A1 (en) 2017-09-07
HRP20182006T1 (hr) 2019-01-25
DK3212667T3 (en) 2018-12-03
CA2989930A1 (en) 2016-05-06
PT3212667T (pt) 2018-12-20
EP3212667B1 (en) 2018-09-19
BR112017009021A2 (pt) 2018-02-06
ES2703586T3 (es) 2019-03-11
DE18190279T1 (de) 2019-07-11
RS58172B1 (sr) 2019-03-29
DE202015009509U9 (de) 2018-05-30
HUP1400510A1 (hu) 2016-05-30
CY1120937T1 (el) 2019-12-11
LT3212667T (lt) 2018-12-10
DE202015009509U1 (de) 2018-01-18
WO2016066688A1 (en) 2016-05-06
SI3212667T1 (sl) 2018-11-30
EP3212667A1 (en) 2017-09-06
DE202015009619U1 (de) 2018-08-29

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