HUE045624T2 - Magnézium ionokkal stabilizált etanercept készítmények - Google Patents

Magnézium ionokkal stabilizált etanercept készítmények

Info

Publication number
HUE045624T2
HUE045624T2 HUE12842352A HUE12842352A HUE045624T2 HU E045624 T2 HUE045624 T2 HU E045624T2 HU E12842352 A HUE12842352 A HU E12842352A HU E12842352 A HUE12842352 A HU E12842352A HU E045624 T2 HUE045624 T2 HU E045624T2
Authority
HU
Hungary
Prior art keywords
magnesium ions
etanercept formulations
formulations stabilized
stabilized
etanercept
Prior art date
Application number
HUE12842352A
Other languages
English (en)
Hungarian (hu)
Inventor
Mark Manning
Brian Murphy
Original Assignee
Coherus Biosciences Inc
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 Coherus Biosciences Inc filed Critical Coherus Biosciences Inc
Publication of HUE045624T2 publication Critical patent/HUE045624T2/hu

Links

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    • 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
    • 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
    • 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
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    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/191—Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
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    • 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
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    • A61K47/02—Inorganic compounds
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • 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
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    • 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
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    • 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
    • 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]
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/81—Protease inhibitors
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Cell Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Pulmonology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
HUE12842352A 2011-10-18 2012-10-18 Magnézium ionokkal stabilizált etanercept készítmények HUE045624T2 (hu)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161548518P 2011-10-18 2011-10-18
US201261669480P 2012-07-09 2012-07-09

Publications (1)

Publication Number Publication Date
HUE045624T2 true HUE045624T2 (hu) 2020-01-28

Family

ID=48136153

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE12842352A HUE045624T2 (hu) 2011-10-18 2012-10-18 Magnézium ionokkal stabilizált etanercept készítmények

Country Status (28)

Country Link
US (21) US10293049B2 (enExample)
EP (6) EP2768533A4 (enExample)
JP (6) JP6220788B2 (enExample)
KR (7) KR20140091705A (enExample)
CN (6) CN103998061A (enExample)
AR (6) AR088383A1 (enExample)
AU (6) AU2012326170B2 (enExample)
BR (6) BR112014009022A2 (enExample)
CA (6) CA2851639C (enExample)
CY (1) CY1121843T1 (enExample)
DK (1) DK2768525T3 (enExample)
EA (6) EA025267B1 (enExample)
ES (1) ES2734070T3 (enExample)
HK (3) HK1200722A1 (enExample)
HR (1) HRP20191215T1 (enExample)
HU (1) HUE045624T2 (enExample)
IL (6) IL231827A0 (enExample)
IN (3) IN2014CN02527A (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) WO2013059412A1 (enExample)

Families Citing this family (36)

* 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
AU2012326170B2 (en) * 2011-10-18 2016-12-22 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
WO2014011629A1 (en) 2012-07-09 2014-01-16 Coherus Biosciences, Inc. Stable aqueous formulations of etanercept
KR102250937B1 (ko) 2012-09-11 2021-05-12 코히러스 바이오사이언시즈, 인코포레이티드 고순도 및 탁월한 수율의 정확하게 폴딩된 에타너셉트
HK1221163A1 (zh) * 2013-05-02 2017-05-26 Mabxience, S.A. Tnfr:fc融合多肽的替代配方
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
LT3060229T (lt) * 2013-10-24 2021-09-27 Astrazeneca Ab Stabilios vandeninės antikūno vaistinės formos
WO2015080513A1 (en) * 2013-11-29 2015-06-04 Hanwha Chemical Corporation A liquid formulation of a fusion protein comprising tnfr and fc region
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
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
US20180200325A1 (en) * 2014-11-18 2018-07-19 Shionogi & Co., Ltd. Stabilized peptide composition
CA2970577A1 (en) 2014-12-22 2016-06-30 Ares Trading S.A. Liquid pharmaceutical composition
US20180256717A1 (en) * 2014-12-23 2018-09-13 Drug Discovery Laboratory As Protein compositions and use thereof
KR102018608B1 (ko) * 2014-12-31 2019-09-06 주식회사 엘지화학 목적하는 함량으로 불순물을 포함하는 TNFR-Fc 융합 단백질의 제조방법
CN104694355B (zh) * 2015-03-20 2016-09-28 吉林大学 葛根护肝保健酒及其制备方法
MX389818B (es) * 2015-08-13 2025-03-20 Landsteiner Scient S A De C V Composicion de estabilidad mejorada de etanercept.
JP5938762B1 (ja) * 2015-09-01 2016-06-22 日揮株式会社 マイクロカプセル製剤及びその製造方法
CN105748414A (zh) * 2016-03-02 2016-07-13 张光泉 抗感染米卡芬净冻干组合物及其制备方法
JPWO2017179683A1 (ja) * 2016-04-15 2019-02-21 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 ミカファンギンの安定化された医薬組成物
ES3064802T3 (en) * 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
KR20180046888A (ko) 2016-10-28 2018-05-09 (주)셀트리온 안정한 약제학적 제제
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
US11603407B2 (en) 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
MX2017013995A (es) * 2017-10-31 2019-05-01 Probiomed S A De C V Formulacion farmaceutica estable de una proteina de fusion.
MX2020005630A (es) * 2017-11-30 2020-08-20 Bio Thera Solutions Ltd Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6.
EP3730126B1 (en) * 2017-12-22 2025-05-14 Samsung Bioepis Co., Ltd. Liquid composition comprising vegf antagonist
CA3042126A1 (en) 2018-05-03 2019-11-03 Seattle Children's Hospital (dba Seattle Children's Research Institute) Methods of treating kawasaki disease
CN111228225B (zh) * 2018-11-28 2022-08-26 鲁南制药集团股份有限公司 一种重组人肿瘤坏死因子受体-Fc融合蛋白冻干制剂
GB201911461D0 (en) * 2019-08-09 2019-09-25 Arecor Ltd Novel composition
EP4065166A4 (en) * 2019-11-26 2023-12-20 Comera Life Sciences, Inc. EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
IL305010A (en) 2021-02-17 2023-10-01 Arecor Ltd An aqueous preparation of a transgenic protein structure that includes an FC domain
CN114788809B (zh) * 2022-01-25 2023-04-14 江苏广承药业有限公司 一种氯雷他定液体制剂
WO2026159667A1 (en) * 2025-01-24 2026-07-30 Hovione Farmaciência Sa Synthetic sugars as enablers for viscosity reduction of highly concentrated biological molecules

Family Cites Families (65)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5605690A (en) 1989-09-05 1997-02-25 Immunex Corporation Methods of lowering active TNF-α levels in mammals using tumor necrosis factor receptor
IT1240314B (it) 1989-09-28 1993-12-07 Immunobiology Research Institutes, Inc. Formulazioni acquose stabilizzate di piccoli peptidi.
NZ256293A (en) 1992-09-15 1997-06-24 Immunex Corp Method of treating tumour necrosis factor - mediated inflammation by use of tnf antagonist
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US5656730A (en) 1995-04-07 1997-08-12 Enzon, Inc. Stabilized monomeric protein compositions
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
US7294481B1 (en) * 1999-01-05 2007-11-13 Immunex Corporation Method for producing recombinant proteins
US6677326B2 (en) * 1999-03-15 2004-01-13 Arakis, Ltd. Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration
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
CA2366785C (en) 1999-04-19 2012-02-07 Immunex Corporation Soluble tumor necrosis factor receptor treatment of medical disorders
BR0108193A (pt) 2000-02-10 2003-02-25 Wyeth Corp Processo para tratamento ou inibição de dano celular ou morte celular
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
WO2003102013A2 (en) * 2001-02-23 2003-12-11 Gonzalez-Villasenor Lucia Iren Methods and compositions for production of recombinant peptides
CA2476934C (en) * 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
EA009079B1 (ru) 2003-02-28 2007-10-26 Арес Трейдинг С.А. Жидкие составы фактор некроза опухоли-связывающих белков
WO2004082715A1 (ja) 2003-03-20 2004-09-30 Eisai Co., Ltd. 炎症性腸疾患治療剤としての併用医薬
SG145712A1 (en) * 2003-08-01 2008-09-29 Amgen Inc Crystalline tumor necrosis factor receptor 2 polypeptides
WO2005037214A2 (en) 2003-10-14 2005-04-28 Intermune, Inc. Macrocyclic carboxylic acids and acylsulfonamides as inhibitors of hcv replication
JP5554466B2 (ja) 2004-03-01 2014-07-23 味の素株式会社 抗ヒトＴＮＦ−α抗体活性低下抑制剤
PL1720972T3 (pl) 2004-03-05 2014-06-30 Dpx Holdings Bv Proces hodowli komórek poprzez ciągłą perfuzję i zmienny przepływ styczny
US20070196364A1 (en) 2004-07-27 2007-08-23 Human Genome Sciences, Inc. Pharmaceutical Formulation and Process
US7597884B2 (en) * 2004-08-09 2009-10-06 Alios Biopharma, Inc. Hyperglycosylated polypeptide variants and methods of use
US7300773B2 (en) 2004-08-27 2007-11-27 Wyeth Research Ireland Limited Production of TNFR-Ig
WO2006122187A2 (en) 2005-05-10 2006-11-16 Biogen Idec Ma Inc. Treating and evaluating inflammatory disorders
CN101237890A (zh) * 2005-06-10 2008-08-06 中外制药株式会社 含有葡甲胺的蛋白质制剂的稳定剂及其利用
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
TW200738261A (en) * 2005-12-20 2007-10-16 Bristol Myers Squibb Co Stable protein formulations
JP5405122B2 (ja) 2005-12-21 2014-02-05 ワイス・エルエルシー 低粘度のタンパク質製剤およびその用途
JP2009525986A (ja) 2006-02-03 2009-07-16 メディミューン，エルエルシー タンパク質製剤
EA015992B1 (ru) 2006-03-17 2012-01-30 Байоджен Айдек Эмэй Инк. Стабилизированное антитело и многовалентная антигенсвязывающая молекула на его основе, способы получения и использования вышеназванного стабилизированного антитела
EP1996076A2 (en) 2006-03-21 2008-12-03 Eugen Oetringer Devices for and methods of analyzing a physiological condition of a physiological subject based on a workload related property
CA2649538C (en) 2006-04-21 2014-06-03 Yatin Gokarn Buffering agents for biopharmaceutical formulations
CN101627117B (zh) * 2006-08-01 2013-10-30 奇尼塔二有限责任公司 医药制造方法
CA2665567C (en) * 2006-10-06 2012-07-03 Amgen Inc. Stable formulations
US7705132B2 (en) 2006-10-20 2010-04-27 Amgen Inc. Stable polypeptide formulations
MX2009004519A (es) 2006-11-03 2009-05-12 Wyeth Corp Sustancias que inhiben la glucolisis en un cultivo de celulas.
EP2129401B8 (en) 2006-12-21 2020-01-15 Amgen Inc. Stable buffered formulations containing polypeptides
CA2679941C (en) 2007-03-02 2016-09-20 Wyeth Use of copper and glutamate in cell culture for production of polypeptides
EP2014760A1 (en) 2007-06-13 2009-01-14 CMC Biopharmaceuticals A/S A method for producing a biopolymer (e.g. polypeptide) in a continuous fermentation process
CA2690382A1 (en) 2007-06-14 2008-12-24 Biogen Idec Ma Inc. Antibody formulations
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
SG2013054218A (en) * 2008-01-15 2014-10-30 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
JP2011514895A (ja) 2008-02-29 2011-05-12 バイオジェン・アイデック・エムエイ・インコーポレイテッド 精製免疫グロブリン融合タンパク質およびその精製方法
WO2011015926A1 (en) 2009-08-03 2011-02-10 Avesthagen Limited A process of fermentation, purification and production of recombinant soluble tumour necrosis factor alfa receptor (tnfr) - human igg fc fusion protein
MX355650B (es) 2009-08-11 2018-04-26 Genentech Inc Produccion de proteinas en medios de cultivo de celulas libres de glutamina.
WO2011049798A1 (en) 2009-10-20 2011-04-28 Merck Sharp & Dohme Corp. Use of mixed mode chromatography for the capture and purification of basic antibody products
EP2516467A2 (en) 2009-12-23 2012-10-31 Emergent Product Development Seattle, LLC Compositions comprising tnf-alpha and il-6 antagonists and methods of use thereof
AU2011246503B2 (en) 2010-04-26 2013-09-26 Novartis Ag Improved cell culture medium
RU2600847C2 (ru) * 2010-05-10 2016-10-27 Интас Биофармасьютикалс Лимитед Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина
EP2598167B1 (en) * 2010-07-30 2015-04-01 Arecor Limited Stabilized aqueous antibody compositions
EP2606119A1 (en) 2010-08-20 2013-06-26 Wyeth LLC Cell culture of growth factor-free adapted cells
KR20130101034A (ko) 2010-08-31 2013-09-12 프리슬랜드 브랜즈 비브이 진핵 세포를 위한 배양 배지
BR112013008738B1 (pt) 2010-10-11 2017-12-19 Abbvie Bahamas Ltd. Method for purification of a protein
RU2614257C2 (ru) 2011-04-20 2017-03-24 Сандоз Аг СТАБИЛЬНЫЕ ЖИДКИЕ ФАРМАЦЕВТИЧЕСКИЕ ПРЕПАРАТЫ СЛИТОГО БЕЛКА TNFR:Fc
UY34105A (es) 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
WO2013003731A2 (en) 2011-06-29 2013-01-03 Insite Vision Incorporated Methods of treating recurrent meibomian glands disorder and thereby decreasing the frequency of recurrence
EA026226B1 (ru) 2011-07-01 2017-03-31 Байоджен Айдек Ма Инк. Не содержащие аргинина композиции слитого fc-полипептида и способы их применения
SI2726600T1 (sl) 2011-07-01 2017-07-31 Amgen Inc. Sesalska celična kultura
US9781540B2 (en) * 2011-07-07 2017-10-03 Qualcomm Incorporated Application relevance determination based on social context
JP6280499B2 (ja) 2011-07-08 2018-02-14 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． Ｆｃ融合タンパク質の精製方法
ES2651483T3 (es) 2011-08-17 2018-01-26 Ares Trading S.A. Método para preparar la forma activa de la proteína de fusión TNRF-Fc
AU2012326170B2 (en) * 2011-10-18 2016-12-22 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
KR102250937B1 (ko) 2012-09-11 2021-05-12 코히러스 바이오사이언시즈, 인코포레이티드 고순도 및 탁월한 수율의 정확하게 폴딩된 에타너셉트

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