JP6884858B2 - 医薬製剤及びその製造方法 - Google Patents

医薬製剤及びその製造方法 Download PDF

Info

Publication number
JP6884858B2
JP6884858B2 JP2019520794A JP2019520794A JP6884858B2 JP 6884858 B2 JP6884858 B2 JP 6884858B2 JP 2019520794 A JP2019520794 A JP 2019520794A JP 2019520794 A JP2019520794 A JP 2019520794A JP 6884858 B2 JP6884858 B2 JP 6884858B2
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
etanercept
composition according
arginine
weeks
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
JP2019520794A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019533679A5 (cg-RX-API-DMAC7.html
JP2019533679A (ja
Inventor
ゴス，モニカ
ボール，ニコール
Original Assignee
アムジエン・インコーポレーテツド
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 アムジエン・インコーポレーテツド filed Critical アムジエン・インコーポレーテツド
Publication of JP2019533679A publication Critical patent/JP2019533679A/ja
Publication of JP2019533679A5 publication Critical patent/JP2019533679A5/ja
Priority to JP2021080160A priority Critical patent/JP7402195B2/ja
Application granted granted Critical
Publication of JP6884858B2 publication Critical patent/JP6884858B2/ja
Priority to JP2023180119A priority patent/JP7754903B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K9/08—Solutions
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • 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
    • 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]
    • 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
    • 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
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/32—Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Mycology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019520794A 2016-10-21 2017-10-19 医薬製剤及びその製造方法 Active JP6884858B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021080160A JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662411458P 2016-10-21 2016-10-21
US62/411,458 2016-10-21
PCT/US2017/057472 WO2018075818A1 (en) 2016-10-21 2017-10-19 Pharmaceutical formulations and methods of making the same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021080160A Division JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法

Publications (3)

Publication Number Publication Date
JP2019533679A JP2019533679A (ja) 2019-11-21
JP2019533679A5 JP2019533679A5 (cg-RX-API-DMAC7.html) 2020-12-10
JP6884858B2 true JP6884858B2 (ja) 2021-06-09

Family

ID=61971152

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019520794A Active JP6884858B2 (ja) 2016-10-21 2017-10-19 医薬製剤及びその製造方法
JP2021080160A Active JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A Active JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2021080160A Active JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A Active JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法

Country Status (13)

Country Link
US (5) US20180110856A1 (cg-RX-API-DMAC7.html)
EP (1) EP3528787B1 (cg-RX-API-DMAC7.html)
JP (3) JP6884858B2 (cg-RX-API-DMAC7.html)
KR (2) KR102413592B1 (cg-RX-API-DMAC7.html)
CN (2) CN109982685B (cg-RX-API-DMAC7.html)
AU (1) AU2017345490B2 (cg-RX-API-DMAC7.html)
CA (1) CA3040899A1 (cg-RX-API-DMAC7.html)
CL (1) CL2019001053A1 (cg-RX-API-DMAC7.html)
EA (1) EA201990998A1 (cg-RX-API-DMAC7.html)
IL (1) IL266132B (cg-RX-API-DMAC7.html)
MX (1) MX2019004580A (cg-RX-API-DMAC7.html)
SG (1) SG11201903521XA (cg-RX-API-DMAC7.html)
WO (1) WO2018075818A1 (cg-RX-API-DMAC7.html)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
EP3709971A2 (en) 2017-11-17 2020-09-23 Amgen Inc. Vegfr-fc fusion protein formulations
WO2021005500A1 (en) * 2019-07-09 2021-01-14 Unichem Laboratories Ltd Stable formulations of recombinant proteins
GB201911461D0 (en) * 2019-08-09 2019-09-25 Arecor Ltd Novel composition
TW202200615A (zh) 2020-03-12 2022-01-01 美商安進公司 用於治療和預防患者的crs之方法
EP4132580A4 (en) * 2020-04-06 2024-05-08 The Board of Trustees of the Leland Stanford Junior University ANTIBODY FORMULATION
US11777543B2 (en) 2020-05-12 2023-10-03 Nec Corporation Distortion compensation apparatus and distortion compensation method

Family Cites Families (158)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2837168A1 (de) 1978-08-25 1980-03-06 Blutspendedienst Dt Rote Kreuz Verfahren zur herstellung einer fuer die intravenoese anwendung geeigneten immunglobulinloesung
US4362661A (en) 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
US4360457A (en) 1979-08-30 1982-11-23 Teijin Limited S-Sulfonated immunoglobulin composition having a high monomer content and a process for production thereof
US4374763A (en) 1979-09-17 1983-02-22 Morishita Pharmaceutical Co., Ltd. Method for producing gamma-globulin for use in intravenous administration and method for producing a pharmaceutical preparation thereof
US4396608A (en) 1981-08-24 1983-08-02 Cutter Laboratories Intravenously injectable immune serum globulin
US5702699A (en) 1982-09-23 1997-12-30 Cetus Corporation Process for the recovery of lipophilic proteins
US4681713A (en) 1984-03-15 1987-07-21 Toyo Boseki Kabushiki Kaisha Method of making a hollow fiber membrane for dialysis
US4597966A (en) 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
US6673347B1 (en) 1986-04-30 2004-01-06 Gryphon Therapeutics Polypeptide and protein derivatives and process for their preparation
GB8628104D0 (en) 1986-11-25 1986-12-31 Connaught Lab Pasteurization of immunoglobin solutions
DE3640513A1 (de) 1986-11-27 1988-06-09 Biotest Pharma Gmbh Verfahren zur herstellung eines virussicheren, lagerstabilen und intravenoes vertraeglichen immunglobulin-g-praeparates
JP2547556B2 (ja) 1987-02-06 1996-10-23 株式会社 ミドリ十字 ｒ−グロブリンの液状製剤
WO1990005183A1 (en) 1988-10-31 1990-05-17 Immunex Corporation Interleukin-4 receptors
US5395760A (en) 1989-09-05 1995-03-07 Immunex Corporation DNA encoding tumor necrosis factor-α and -β receptors
DE10399023I2 (de) 1989-09-12 2006-11-23 Ahp Mfg B V TFN-bindende Proteine
DE3939346A1 (de) 1989-11-29 1991-06-06 Behringwerke Ag Arzneimitel zur subkutanen oder intramuskulaeren applikation enthaltend polypeptide
US5945098A (en) 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
US5177194A (en) 1990-02-01 1993-01-05 Baxter International, Inc. Process for purifying immune serum globulins
GB9017002D0 (en) 1990-08-02 1990-09-19 Health Lab Service Board Improved method for the purification of erwina l-asparaginase
JP3179538B2 (ja) 1990-12-11 2001-06-25 ノバルティス アクチエンゲゼルシャフト 安定なヒトカルシトニンの水性溶液
US5110910A (en) 1991-03-25 1992-05-05 Miles Inc. Virucidal euglobulin precipitation
US5256571A (en) 1991-05-01 1993-10-26 Cytyc Corporation Cell preservative solution
EP0619324B1 (en) 1991-12-20 2002-07-03 Yamanouchi Pharmaceutical Co. Ltd. HUMAN TYPE ANTIBODY REACTIVE WITH GPIIb/IIIa
US6004555A (en) 1992-03-05 1999-12-21 Board Of Regents, The University Of Texas System Methods for the specific coagulation of vasculature
US5298410A (en) 1993-02-25 1994-03-29 Sterling Winthrop Inc. Lyophilized formulation of polyethylene oxide modified proteins with increased shelf-life
US5484892A (en) 1993-05-21 1996-01-16 Dana-Farber Cancer Institute, Inc. Monoclonal antibodies that block ligand binding to the CD22 receptor in mature B cells
DE4344824C1 (de) 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
GB9401448D0 (en) 1994-01-26 1994-03-23 Ciba Geigy Ag Stable dry powders
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
ATE306930T1 (de) 1994-08-12 2005-11-15 Immunomedics Inc Für b-zell-lymphom und leukämiezellen spezifische immunkonjugate und humane antikörper
US6090382A (en) 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
WO1997029131A1 (en) 1996-02-09 1997-08-14 Basf Aktiengesellschaft HUMAN ANTIBODIES THAT BIND HUMAN TNF$g(a)
TW518219B (en) 1996-04-26 2003-01-21 Chugai Pharmaceutical Co Ltd Erythropoietin solution preparation
GB9610992D0 (en) 1996-05-24 1996-07-31 Glaxo Group Ltd Concentrated antibody preparation
TW555765B (en) 1996-07-09 2003-10-01 Amgen Inc Low molecular weight soluble tumor necrosis factor type-I and type-II proteins
EP0954534A1 (en) 1996-07-18 1999-11-10 Csl Limited Pasteurization of immunoglobulin solutions
TW491855B (en) 1996-08-07 2002-06-21 Csl Ltd Purification of immunoglobulins
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US5886154A (en) 1997-06-20 1999-03-23 Lebing; Wytold R. Chromatographic method for high yield purification and viral inactivation of antibodies
JP3679406B2 (ja) 1998-05-20 2005-08-03 協和醗酵工業株式会社 遺伝子組換え抗体
US6436897B2 (en) 1998-06-01 2002-08-20 Celtrix Pharmaceuticals, Inc. Pharmaceutical formulations for IGF/IGFBP
DK2270044T3 (en) 1998-06-09 2015-01-26 Csl Behring Ag Liquid immunoglobulin G (IgG) product
US6610206B1 (en) 1998-10-20 2003-08-26 Advanced Renal Technologies Buffered compositions for dialysis
IL127127A0 (en) 1998-11-18 1999-09-22 Peptor Ltd Small functional units of antibody heavy chain variable regions
US7294481B1 (en) 1999-01-05 2007-11-13 Immunex Corporation Method for producing recombinant proteins
SI1149114T1 (sl) 1999-02-03 2014-08-29 Amgen Inc. Polipeptidi, vkljuäśeni v imunskem odgovoru
ATE251466T1 (de) 1999-04-08 2003-10-15 Genentech Inc Zusammensetzung auf basis gegensätzlich geladener polypeptide
DE60039598D1 (de) 1999-04-09 2008-09-04 Ortho Mcneil Pharm Inc Pharmazeutische zusammensetzungen von erythropoietin
AU4363200A (en) 1999-04-19 2000-11-02 Immunex Corporation Soluble tumor necrosis factor receptor treatment of medical desorders
US20010021380A1 (en) 1999-04-19 2001-09-13 Pluenneke John D. Soluble tumor necrosis factor receptor treatment of medical disorders
US20040220103A1 (en) 1999-04-19 2004-11-04 Immunex Corporation Soluble tumor necrosis factor receptor treatment of medical disorders
CA2477857C (en) 1999-10-04 2012-04-10 Chiron Corporation Stabilized liquid polypeptide-containing pharmaceutical compositions
EP1237575B1 (en) 1999-12-14 2008-08-06 Genentech, Inc. Tnf-alpha antagonist and lfa-1 antagonist for treating rheumatoid arthritis
JP2004500063A (ja) 1999-12-16 2004-01-08 アムジェン　インコーポレイテッド Ｔｎｆｒ／ｏｐｇ様分子およびその使用
WO2001058473A1 (en) 2000-02-10 2001-08-16 Wyeth Method of treating or inhibiting cellular injury or cell death
EP1666052B1 (en) 2000-02-16 2011-06-08 Genentech, Inc. Anti-APRIL monoclonal antibody and its use for the treatment of an immune related disease or cancer
US20050209447A1 (en) 2000-07-25 2005-09-22 Takashi Ito Process for producing recombinant protein
EP1336410A4 (en) 2000-08-04 2005-10-12 Chugai Pharmaceutical Co Ltd PROTEIN INJECTION PREPARATIONS
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
EP1324776B2 (en) 2000-10-12 2018-03-21 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2002047721A1 (en) 2000-12-14 2002-06-20 Fujisawa Pharmaceutical Co., Ltd. Silensed anti-cd28 antibodies and use thereof
US6693173B2 (en) 2000-12-26 2004-02-17 Alpha Therapeutic Corporation Method to remove citrate and aluminum from proteins
GEP20084484B (en) 2001-01-05 2008-09-25 Pfizer Antibodies to insulin-like growth factor i receptor
ES2184594B1 (es) 2001-01-17 2004-01-01 Probitas Pharma Sa Procedimiento para la produccion de gammaglobulina g humana inactivada de virus.
CN1547586A (zh) 2001-02-23 2004-11-17 ���鹫˾ 提高的活性蛋白回收率
GB0113179D0 (en) 2001-05-31 2001-07-25 Novartis Ag Organic compounds
EP1405331A1 (en) 2001-06-25 2004-04-07 Koninklijke Philips Electronics N.V. High-pressure gas discharge lamp and method of manufacturing the same
TR201809008T4 (tr) 2001-06-26 2018-07-23 Amgen Fremont Inc Opgl ye karşi antikorlar.
EP1425389B1 (en) * 2001-08-23 2011-11-02 Genmab A/S Human antibodies specific for interleukin 15 (il-15)
US7247304B2 (en) 2001-08-23 2007-07-24 Genmab A/S Methods of treating using anti-IL-15 antibodies
WO2003024388A2 (en) 2001-09-20 2003-03-27 Cornell Research Foundation, Inc. Methods and compositions for treating and preventing skin disorders using binding agents specific for psma
US20030138417A1 (en) 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
EP1585477A4 (en) 2001-11-30 2007-06-27 Centocor Inc ANTI-TNF ANTIBODIES, COMPOSITIONS, METHODS AND USES
WO2003059935A2 (en) 2001-12-21 2003-07-24 Immunex Corporation Methods for purifying protein
EP3192528A1 (en) 2002-02-14 2017-07-19 Chugai Seiyaku Kabushiki Kaisha Formulation of anti-il6r antibody-containing solutions comprising a sugar as a stabilizer
DE60334364D1 (de) 2002-02-21 2010-11-11 Univ California Behandlungsverfahren unter verwendung von anti-cd22-antikörpern
ES2311094T3 (es) 2002-02-27 2009-02-01 Immunex Corporation Composicion estabilizada de tnfr-fc que comprende arginina.
EP1497444B1 (en) 2002-03-27 2015-11-04 Immunex Corporation Methods for increasing polypeptide production
EP2314316A1 (en) 2002-04-05 2011-04-27 Amgen, Inc Human anti-OPGL neutralizing antibodies as selective OPGL pathway inhibitors
DE10218570B4 (de) 2002-04-26 2007-10-18 Lohmann Gmbh & Co Kg Acrylatcopolymere und daraus erhältliche Haftklebemassen zum Verkleben von niederenergetischen Oberflächen sowie ihre Verwendung
DK1501369T3 (en) 2002-04-26 2015-09-28 Genentech Inc Non-affinity purification of proteins
US20030206898A1 (en) 2002-04-26 2003-11-06 Steven Fischkoff Use of anti-TNFalpha antibodies and another drug
GB0210121D0 (en) 2002-05-02 2002-06-12 Celltech R&D Ltd Biological products
AU2003251592A1 (en) 2002-06-21 2004-01-06 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of use thereof
US20040136991A1 (en) 2002-07-19 2004-07-15 Abbott Biotechnology Ltd. Treatment of anemia using TNFalpha inhibitors
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP4500683B2 (ja) 2002-11-01 2010-07-14 バイエル・ヘルスケア・エルエルシー 巨大分子濃縮方法
US20040086532A1 (en) 2002-11-05 2004-05-06 Allergan, Inc., Botulinum toxin formulations for oral administration
EA009056B1 (ru) 2002-12-20 2007-10-26 Амген, Инк. Связывающие агенты, ингибирующие миостатин
EP1603948A1 (en) 2003-03-14 2005-12-14 Pharmacia Corporation Antibodies to igf-i receptor for the treatment of cancers
JP4869064B2 (ja) 2003-04-04 2012-02-01 ジェネンテック， インコーポレイテッド 高濃度抗体及びタンパク質製剤
CA2524710C (en) 2003-05-14 2012-07-31 Dow Corning Corporation Controlled release of active agents utilizing repeat sequence protein polymers
EP1631317A2 (en) 2003-06-06 2006-03-08 Regeneron Pharmaceuticals, Inc. Use of vegf inhibitors for tumor regression
DE602004017726D1 (de) 2003-06-30 2008-12-24 Domantis Ltd Pegylierte Single-domain-antikörper (dAb)
TWI356064B (en) 2003-11-07 2012-01-11 Immunex Corp Antibodies that bind interleukin-4 receptor
EP1532983A1 (en) 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
US20070172475A1 (en) 2004-02-12 2007-07-26 Susanne Matheus Highly concentrated, liquid formulations of anti-egfr antibodies
WO2005095454A1 (en) 2004-03-25 2005-10-13 Diadexus, Inc. Lng105 antibody composition and methods of use, and use of lng105 to assess lung cancer risk
CA2566075A1 (en) 2004-05-12 2005-12-01 Baxter Healthcare S.A. Microspheres comprising protein and showing injectability at high concentrations of said agent
JPWO2006003999A1 (ja) 2004-07-05 2008-07-31 財団法人化学及血清療法研究所 ヒト抗ヒトｂ７ｒｐ−１抗体およびその抗体フラグメント
US7648742B2 (en) * 2004-07-29 2010-01-19 Merck Patent Gmbh Difluorosubstituted heterocyclic compounds and the use thereof in the form of components in liquid crystalline media
TW200621282A (en) 2004-08-13 2006-07-01 Wyeth Corp Stabilizing formulations
TWI364458B (en) 2004-08-27 2012-05-21 Wyeth Res Ireland Ltd Production of tnfr-lg
CA2581208A1 (en) 2004-08-30 2006-03-09 Lonza Biologics Plc. Affinity- plus ion exchange- chromatography for purifying antibodies
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2006064373A2 (en) 2004-12-16 2006-06-22 Genzyme Polyclonals S.A.S. Methods of purifying immunologlobulins
JP4498939B2 (ja) 2005-02-01 2010-07-07 東京応化工業株式会社 ポジ型レジスト組成物およびレジストパターン形成方法
US8597709B2 (en) 2005-04-12 2013-12-03 Inovobiologic Inc. Dietary supplement and methods of use
MX2007015476A (es) 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
US7612181B2 (en) 2005-08-19 2009-11-03 Abbott Laboratories Dual variable domain immunoglobulin and uses thereof
US20070049732A1 (en) 2005-09-01 2007-03-01 Zurlo Eugene J Ultra-high yield intravenous immune globulin preparation
AU2006294324B2 (en) 2005-09-21 2012-01-19 Burcon Nutrascience (Mb) Corp. Preparation of canola protein isolate involving isoelectric precipitation
US8067350B2 (en) 2005-12-15 2011-11-29 Kimberly-Clark Worldwide, Inc. Color changing cleansing composition
US20070202051A1 (en) 2006-02-10 2007-08-30 Pari Gmbh Aerosols for sinunasal drug delivery
MX2008013535A (es) 2006-04-21 2008-10-29 Amgen Inc Agentes amortiguadores para formulaciones biofarmaceuticas.
EA018301B1 (ru) 2006-04-21 2013-07-30 Новартис Аг Фармацевтические композиции, содержащие антагонистическое моноклональное антитело к cd40, и их применение
AU2007294680A1 (en) 2006-09-15 2008-03-20 Barofold, Inc. High pressure treatment of proteins for reduced immunogenicity
NZ613356A (en) 2006-10-27 2015-02-27 Abbvie Biotechnology Ltd Crystalline anti-htnfalpha antibodies
EP2129401B8 (en) 2006-12-21 2020-01-15 Amgen Inc. Stable buffered formulations containing polypeptides
TW200938221A (en) * 2007-11-30 2009-09-16 Abbott Lab Protein formulations and methods of making same
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
SG10201402265YA (en) * 2008-02-07 2014-08-28 Amgen Inc Stabilized protein compositions
US8177749B2 (en) 2008-05-20 2012-05-15 Avant Medical Corp. Cassette for a hidden injection needle
MX383374B (es) 2008-05-20 2025-03-13 Avant Medical Corp Sistema auto-inyector.
US8052645B2 (en) 2008-07-23 2011-11-08 Avant Medical Corp. System and method for an injection using a syringe needle
EP2331090B1 (en) * 2008-09-19 2018-01-03 Pfizer Inc. Stable liquid antibody formulation
KR101593285B1 (ko) * 2008-10-29 2016-02-11 아블린쓰 엔.브이. 단일 도메인 항원 결합 분자의 제형
BRPI1006519A2 (pt) 2009-03-06 2016-08-09 Genentech Inc formulação de anticorpos
US20110070227A1 (en) 2009-09-18 2011-03-24 Anna-Marie Novotney-Barry Treatment of Autoimmune and Inflammatory Diseases
TWI606840B (zh) 2010-11-11 2017-12-01 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
US9084849B2 (en) 2011-01-26 2015-07-21 Kaleo, Inc. Medicament delivery devices for administration of a medicament within a prefilled syringe
JP6038884B2 (ja) 2011-04-20 2016-12-07 アムゲン・インコーポレーテッド 自動式注射装置
EP2699265B1 (en) * 2011-04-20 2019-10-16 Sandoz AG STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
EA026226B1 (ru) 2011-07-01 2017-03-31 Байоджен Айдек Ма Инк. Не содержащие аргинина композиции слитого fc-полипептида и способы их применения
CN104010658A (zh) * 2011-10-18 2014-08-27 科荣生生物科学公司 使用葡甲胺稳定的依那西普制剂
EP2863951A1 (en) * 2012-06-12 2015-04-29 Boehringer Ingelheim International GmbH Pharmaceutical formulation for a therapeutic antibody
EP2869871B1 (en) 2012-07-05 2021-03-17 UNL Holdings LLC Automatic injectors for injectable cartridges and drive control mechanisms therefor
EP2869817A4 (en) * 2012-07-09 2016-04-06 Coherus Biosciences Inc STABLE AQUEOUS FORMULATIONS OF ETANERCEPT
AU2013315750B9 (en) * 2012-09-11 2018-11-15 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
EP2919801B1 (en) 2012-10-26 2020-04-29 Lupin Atlantis Holdings, SA Stable pharmaceutical composition of the tnfr:fc fusion protein etanercept
US9649383B2 (en) 2012-11-19 2017-05-16 Merck Sharp & Dohme Corp. Liquid formulations for TNFR:Fc fusion proteins
EP2926834A4 (en) 2012-11-27 2016-04-20 Alteogen Inc COMPOSITION FOR STABILIZING A FUSION PROTEIN IN WHICH A PROTEIN AND A DOMAIN FC ARE MERGED
AR094458A1 (es) 2012-12-06 2015-08-05 Iams Co Alimento con formas perceptibles para mascotas
US9452138B2 (en) 2012-12-28 2016-09-27 Abbott Cardiovascular Systems Inc. Delivery of biologic therapeutics
WO2014144096A1 (en) 2013-03-15 2014-09-18 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
TWI639449B (zh) 2013-03-15 2018-11-01 美商安美基公司 用於注射器之匣盒
RU2663727C2 (ru) 2013-05-02 2018-08-08 Мабксьенсе С.А. Альтернативные составы для химерных полипептидов tnfr:fc
WO2015061584A1 (en) 2013-10-24 2015-04-30 Medimmune, Llc Stable, aqueous antibody formulations
EP3073992A4 (en) * 2013-11-29 2017-09-13 Ares Trading S.A. A liquid formulation of a fusion protein comprising tnfr and fc region
EP2975050B1 (en) 2014-07-18 2019-05-29 Sandoz Ag Quantification of misfolded TNFR2:Fc
WO2016033507A2 (en) 2014-08-28 2016-03-03 Unitract Syringe Pty Ltd Sensor systems for drug delivery devices
WO2016033496A1 (en) 2014-08-28 2016-03-03 Unitract Syringe Pty Ltd Skin sensors for drug delivery devices
EP3236990B1 (en) * 2014-12-22 2020-09-02 Ares Trading S.A. Liquid pharmaceutical composition
KR20240132521A (ko) 2015-03-13 2024-09-03 삼성바이오에피스 주식회사 항-tnf-알파 폴리펩티드 조성물 및 그 용도
US9763976B1 (en) 2016-08-02 2017-09-19 Zo Skin Health, Inc. Composition and method for treating skin conditions
CA3040899A1 (en) 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical formulations and methods of making the same

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
JP7402195B2 (ja) 2016-10-21 2023-12-20 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

Also Published As

Publication number Publication date
US20180110856A1 (en) 2018-04-26
US20230080571A1 (en) 2023-03-16
WO2018075818A1 (en) 2018-04-26
IL266132A (en) 2019-06-30
JP7754903B2 (ja) 2025-10-15
JP2019533679A (ja) 2019-11-21
US11491223B2 (en) 2022-11-08
AU2017345490B2 (en) 2022-07-07
CA3040899A1 (en) 2018-04-26
US12214013B2 (en) 2025-02-04
SG11201903521XA (en) 2019-05-30
CN109982685B (zh) 2022-03-11
EP3528787B1 (en) 2026-01-07
US20250134958A1 (en) 2025-05-01
JP2021120393A (ja) 2021-08-19
JP7402195B2 (ja) 2023-12-20
KR102446838B1 (ko) 2022-09-26
CN114917185A (zh) 2022-08-19
MX2019004580A (es) 2019-08-12
US10307483B2 (en) 2019-06-04
EP3528787A1 (en) 2019-08-28
US20180256718A1 (en) 2018-09-13
KR20210158878A (ko) 2021-12-31
BR112019007858A2 (pt) 2019-07-02
CN114917185B (zh) 2023-11-14
EP3528787A4 (en) 2020-05-06
CN109982685A (zh) 2019-07-05
AU2017345490A1 (en) 2019-05-09
US20190022217A1 (en) 2019-01-24
CL2019001053A1 (es) 2019-08-02
KR20190071760A (ko) 2019-06-24
EA201990998A1 (ru) 2019-11-29
KR102413592B1 (ko) 2022-06-27
IL266132B (en) 2021-12-01
JP2024010026A (ja) 2024-01-23

Similar Documents

Publication Publication Date Title
JP6884858B2 (ja) 医薬製剤及びその製造方法
EP4249512B1 (en) Stable antibody formulation
US11135267B2 (en) Etanercept formulations stabilized with metal ions
WO2020128792A1 (en) Protein solution formulation containing high concentration of an anti-vegf antibody
US10959939B2 (en) Liquid pharmaceutical composition of etanercept with lysine and proline
JP2022546400A (ja) 高濃度の薬理学的に活性な抗体の新規製剤
EA041785B1 (ru) Фармацевтическая композиция и способ ее получения
HK40005823A (en) Pharmaceutical formulations and methods of making the same
HK40005823B (en) Pharmaceutical formulations and methods of making the same
BR112019007858B1 (pt) Composições farmacêuticas, métodos relacionados, kit, recipiente de dose única e uso

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20201014

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20201014

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20201014

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20201027

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20201030

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20201124

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210219

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20210413

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20210512

R150 Certificate of patent or registration of utility model

Ref document number: 6884858

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250