PL2919801T3 - Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu - Google Patents

Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu

Info

Publication number
PL2919801T3
PL2919801T3 PL13795585T PL13795585T PL2919801T3 PL 2919801 T3 PL2919801 T3 PL 2919801T3 PL 13795585 T PL13795585 T PL 13795585T PL 13795585 T PL13795585 T PL 13795585T PL 2919801 T3 PL2919801 T3 PL 2919801T3
Authority
PL
Poland
Prior art keywords
tnfr
pharmaceutical composition
fusion protein
stable pharmaceutical
protein etanercept
Prior art date
Application number
PL13795585T
Other languages
English (en)
Polish (pl)
Inventor
Anjali Deepak Apte-Deshpande
Vaibhav Dyaneshwar Deokar
Rustom Sorab Mody
Original Assignee
Lupin Atlantis Holdings, Sa
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 Lupin Atlantis Holdings, Sa filed Critical Lupin Atlantis Holdings, Sa
Publication of PL2919801T3 publication Critical patent/PL2919801T3/pl

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Inorganic Chemistry (AREA)
PL13795585T 2012-10-26 2013-10-24 Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu PL2919801T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN1235KO2012 2012-10-26
IN1236KO2012 2012-10-26
EP13795585.2A EP2919801B1 (en) 2012-10-26 2013-10-24 Stable pharmaceutical composition of the tnfr:fc fusion protein etanercept
PCT/IB2013/059612 WO2014064637A1 (en) 2012-10-26 2013-10-24 Stable pharmaceutical composition of tnfr:fc fusion protein

Publications (1)

Publication Number Publication Date
PL2919801T3 true PL2919801T3 (pl) 2021-01-25

Family

ID=54208810

Family Applications (1)

Application Number Title Priority Date Filing Date
PL13795585T PL2919801T3 (pl) 2012-10-26 2013-10-24 Stabilna kompozycja farmaceutyczna białka fuzyjnego TNFR:FC etanerceptu

Country Status (14)

Country Link
US (2) US10058589B2 (enExample)
EP (1) EP2919801B1 (enExample)
JP (1) JP6431844B2 (enExample)
KR (1) KR102132050B1 (enExample)
CN (1) CN104936607A (enExample)
AU (1) AU2013336279B2 (enExample)
BR (1) BR112015009462A2 (enExample)
CA (1) CA2889271A1 (enExample)
ES (1) ES2806946T3 (enExample)
MX (1) MX366622B (enExample)
PL (1) PL2919801T3 (enExample)
PT (1) PT2919801T (enExample)
RU (1) RU2664691C2 (enExample)
WO (1) WO2014064637A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
HK1221163A1 (zh) * 2013-05-02 2017-05-26 Mabxience, S.A. Tnfr:fc融合多肽的替代配方
JP6480154B2 (ja) * 2014-11-06 2019-03-06 持田製薬株式会社 エタネルセプトの凍結乾燥製剤
MX389818B (es) * 2015-08-13 2025-03-20 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
ES3064802T3 (en) * 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
CN111432880A (zh) * 2017-08-08 2020-07-17 瑞士杰特贝林生物制品有限公司 血色素结合蛋白制剂
CA3042126A1 (en) 2018-05-03 2019-11-03 Seattle Children's Hospital (dba Seattle Children's Research Institute) Methods of treating kawasaki disease
WO2022264097A1 (en) 2021-06-17 2022-12-22 Lupin Limited Pharmaceutical composition of anti-tumour necrosis factor (anti-tnf) agent for management of infectious diseases caused by coronaviruses
CN122459015A (zh) * 2024-05-31 2026-07-24 荣昌生物制药(烟台)股份有限公司 环糊精及其衍生物作为保护剂在制备TACI-Fc融合蛋白液体药物制剂中的用途

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5215743A (en) 1988-04-13 1993-06-01 Maninder Singh Tumor necrosis factor formulations
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
DE4239877C1 (de) * 1992-11-27 1994-03-17 Boehringer Ingelheim Int Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung
DK1017413T4 (da) * 1997-09-23 2008-03-25 Rentschler Biotech Gmbh Flydende formulering af interferon-beta
CA2476934C (en) * 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
EA009079B1 (ru) 2003-02-28 2007-10-26 Арес Трейдинг С.А. Жидкие составы фактор некроза опухоли-связывающих белков
ES2310122B1 (es) * 2007-04-20 2009-10-30 Instituto Cientifico Y Tecnologico De Navarra, S.A Nanoparticulas que comprenden una ciclodextrina y una molecula biologicamente activa y sus aplicaciones.
WO2009133529A2 (en) * 2008-04-30 2009-11-05 Wockhardt Research Centre Processes for refolding of insulin
US20100278822A1 (en) * 2009-05-04 2010-11-04 Abbott Biotechnology, Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
RU2600847C2 (ru) 2010-05-10 2016-10-27 Интас Биофармасьютикалс Лимитед Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина
TWI603739B (zh) * 2010-11-11 2017-11-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗－ＴＮＦα抗體之液體調配物
RU2614257C2 (ru) * 2011-04-20 2017-03-24 Сандоз Аг СТАБИЛЬНЫЕ ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ ПРЕПАРАТЫ СЛИТОГО БЕЛКА TNFR:Fc

Also Published As

Publication number Publication date
AU2013336279A1 (en) 2015-05-14
KR20150074069A (ko) 2015-07-01
CN104936607A (zh) 2015-09-23
EP2919801B1 (en) 2020-04-29
RU2664691C2 (ru) 2018-08-21
MX2015005231A (es) 2015-10-29
ES2806946T3 (es) 2021-02-19
BR112015009462A2 (pt) 2017-07-04
US20150283241A1 (en) 2015-10-08
KR102132050B1 (ko) 2020-07-10
AU2013336279B2 (en) 2018-07-19
JP2015535237A (ja) 2015-12-10
PT2919801T (pt) 2020-07-30
JP6431844B2 (ja) 2018-11-28
RU2015119603A (ru) 2016-12-20
US20180236030A1 (en) 2018-08-23
EP2919801A1 (en) 2015-09-23
US10058589B2 (en) 2018-08-28
MX366622B (es) 2019-07-16
WO2014064637A1 (en) 2014-05-01
CA2889271A1 (en) 2014-05-01

Similar Documents

Publication Publication Date Title
PT2919801T (pt) Composição farmacêutica estável da proteína de fusão tnfr:fc etanercept
EP2919812A4 (en) Liquid formulations for TNFR: FC fusion proteins
ZA201500228B (en) Ctla4 fusion proteins for the treatment of diabetes
SI2697257T1 (sl) FC fuzijski proteini, ki vsebujejo nove linkerje ali razmestitve
SMT201900242T1 (it) Incremento dell'attivita' anti-cancro di proteine di fuzione a fc immunomodulatrici
ZA201400490B (en) Arginine- free tnfr: fc- fusion polypeptide compositions and methods of use
IL231009A0 (en) Bicyclic heteroaromatic compounds, their preparation and pharmaceutical preparations containing them
EP3073992A4 (en) A liquid formulation of a fusion protein comprising tnfr and fc region
DK2728002T3 (da) Heterodimeriseret polypeptid
EP2822575A4 (en) MANIPULATED ANTIBODY-INTERFERON-MUTANT FUSION MOLECULES
PH12014500197A1 (en) Stable liquid formulation of etanercept
EP2649132A4 (en) MIXED PROTEIN COMPOSITION BY MELTING
IL232743A0 (en) anticancer fusion protein
PL2776460T3 (pl) Białko fuzyjne zawierające interleukinę 4 i interleukinę 10
EP3000825A4 (en) Trans-tumoral peptide specific to neuropilin and fusion protein having same peptide fused therein
SMT201700300T1 (it) "proteina di fusione anticancro
EP2698386B8 (en) Fusion protein
EP2926834A4 (en) COMPOSITION FOR STABILIZING A FUSION PROTEIN IN WHICH A PROTEIN AND A DOMAIN FC ARE MERGED
SG11201508900UA (en) Alternative formulations for tnfr: fc fusion polypeptides
SG11201405578TA (en) Pharmaceutical composition containing peptide
SG11201405013RA (en) Tumour necrosis factor receptor fusion proteins and methods of using the same
EP3085384A4 (en) Pharmaceutical composition with improved stability containing factor vii fusion protein
HK1197643A (en) Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use
HK1242333A1 (en) Process for the purification of tnfr:fc fusion protein
AU2012901619A0 (en) Fusion Proteins and Use Thereof