JP6104922B2 - アミノ酸によって安定化されたエタネルセプト製剤 - Google Patents

アミノ酸によって安定化されたエタネルセプト製剤 Download PDF

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JP6104922B2
JP6104922B2 JP2014537218A JP2014537218A JP6104922B2 JP 6104922 B2 JP6104922 B2 JP 6104922B2 JP 2014537218 A JP2014537218 A JP 2014537218A JP 2014537218 A JP2014537218 A JP 2014537218A JP 6104922 B2 JP6104922 B2 JP 6104922B2
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etanercept
peak
formulation
composition
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JP2014530254A (ja
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マニング,マーク
マーフィ,ブライアン
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コヒラス・バイオサイエンシズ・インコーポレイテッド
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    • 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
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    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
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    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
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    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/191Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
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    • 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
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    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
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    • A61K47/51Medicinal 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
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    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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JP2014537218A 2011-10-18 2012-10-18 アミノ酸によって安定化されたエタネルセプト製剤 Expired - Fee Related JP6104922B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161548518P 2011-10-18 2011-10-18
US61/548,518 2011-10-18
US201261669480P 2012-07-09 2012-07-09
US61/669,480 2012-07-09
PCT/US2012/060738 WO2013059405A1 (en) 2011-10-18 2012-10-18 Etanercept formulations stabilized with amino acids

Publications (2)

Publication Number Publication Date
JP2014530254A JP2014530254A (ja) 2014-11-17
JP6104922B2 true JP6104922B2 (ja) 2017-03-29

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JP2014537218A Expired - Fee Related JP6104922B2 (ja) 2011-10-18 2012-10-18 アミノ酸によって安定化されたエタネルセプト製剤
JP2014537220A Expired - Fee Related JP6220788B2 (ja) 2011-10-18 2012-10-18 塩化ナトリウムによって安定化されたエタネルセプト製剤
JP2014537222A Expired - Fee Related JP6113176B2 (ja) 2011-10-18 2012-10-18 キシリトールによって安定化されたエタネルセプト製剤
JP2014537219A Expired - Fee Related JP6110393B2 (ja) 2011-10-18 2012-10-18 金属イオンによって安定化されたエタネルセプト製剤
JP2014537221A Expired - Fee Related JP6199298B2 (ja) 2011-10-18 2012-10-18 メグルミンによって安定化されたエタネルセプト製剤
JP2014537223A Expired - Fee Related JP6220789B2 (ja) 2011-10-18 2012-10-18 糖およびポリオールの組合せによって安定化されたエタネルセプト製剤

Family Applications After (5)

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JP2014537220A Expired - Fee Related JP6220788B2 (ja) 2011-10-18 2012-10-18 塩化ナトリウムによって安定化されたエタネルセプト製剤
JP2014537222A Expired - Fee Related JP6113176B2 (ja) 2011-10-18 2012-10-18 キシリトールによって安定化されたエタネルセプト製剤
JP2014537219A Expired - Fee Related JP6110393B2 (ja) 2011-10-18 2012-10-18 金属イオンによって安定化されたエタネルセプト製剤
JP2014537221A Expired - Fee Related JP6199298B2 (ja) 2011-10-18 2012-10-18 メグルミンによって安定化されたエタネルセプト製剤
JP2014537223A Expired - Fee Related JP6220789B2 (ja) 2011-10-18 2012-10-18 糖およびポリオールの組合せによって安定化されたエタネルセプト製剤

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Country Link
US (21) US10293049B2 (enExample)
EP (6) EP2768533A4 (enExample)
JP (6) JP6104922B2 (enExample)
KR (7) KR20140091706A (enExample)
CN (6) CN104010654B (enExample)
AR (6) AR088460A1 (enExample)
AU (6) AU2012326080B2 (enExample)
BR (6) BR112014009087A2 (enExample)
CA (6) CA2851646A1 (enExample)
CY (1) CY1121843T1 (enExample)
DK (1) DK2768525T3 (enExample)
EA (6) EA201490804A1 (enExample)
ES (1) ES2734070T3 (enExample)
HK (3) HK1200722A1 (enExample)
HR (1) HRP20191215T1 (enExample)
HU (1) HUE045624T2 (enExample)
IL (6) IL231824A0 (enExample)
IN (3) IN2014CN02591A (enExample)
LT (1) LT2768525T (enExample)
MX (7) MX367054B (enExample)
PL (1) PL2768525T3 (enExample)
PT (1) PT2768525T (enExample)
RS (1) RS59179B1 (enExample)
SG (6) SG11201401562RA (enExample)
SI (1) SI2768525T1 (enExample)
SM (1) SMT201900422T1 (enExample)
TW (6) TW201325606A (enExample)
WO (6) WO2013059408A1 (enExample)

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WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
SG11201401562RA (en) * 2011-10-18 2014-09-26 Coherus Biosciences Inc Etanercept formulations stabilized with sodium chloride
US10493151B2 (en) 2011-10-18 2019-12-03 Coherus Biosciences, Inc. Etanercept formulations stabilized with sodium chloride
JP6271536B2 (ja) * 2012-07-09 2018-01-31 コヒラス・バイオサイエンシズ・インコーポレイテッド 肉眼不可視粒子の著しい低減を示すエタネルセプト製剤
AU2013315750B9 (en) * 2012-09-11 2018-11-15 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
JP2016518386A (ja) * 2013-05-02 2016-06-23 マブキシェンス エス.アー. TNFR:Fc融合ポリペプチドの代替配合物
WO2015056613A1 (ja) * 2013-10-15 2015-04-23 Meiji Seikaファルマ株式会社 安定化されたポリペプチド水性製剤
CN113350278B (zh) * 2013-10-24 2023-03-24 阿斯利康(瑞典)有限公司 稳定的水性抗体配制品
BR112016011224A2 (pt) 2013-11-29 2017-09-19 Ares Trading Sa Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc
IS3008B (is) * 2014-05-14 2018-12-15 Calor ehf Stöðgandi lausnir fyrir prótín og peptíð
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
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