JP2013531679A - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP2013531679A
JP2013531679A JP2013518765A JP2013518765A JP2013531679A JP 2013531679 A JP2013531679 A JP 2013531679A JP 2013518765 A JP2013518765 A JP 2013518765A JP 2013518765 A JP2013518765 A JP 2013518765A JP 2013531679 A JP2013531679 A JP 2013531679A
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JP
Japan
Prior art keywords
antibody
formulation
antibody fragment
rsa
sucrose
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Pending
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JP2013518765A
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English (en)
Japanese (ja)
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JP2013531679A5 (enExample
Inventor
ディミトロヴァ，マリアーナ，エヌ．
モーディ，ニール
Original Assignee
メディミューン，エルエルシー
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Application filed by メディミューン，エルエルシー filed Critical メディミューン，エルエルシー
Publication of JP2013531679A publication Critical patent/JP2013531679A/ja
Publication of JP2013531679A5 publication Critical patent/JP2013531679A5/ja
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K47/08—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2013518765A 2010-07-02 2011-07-01 抗体製剤 Pending JP2013531679A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US36120910P 2010-07-02 2010-07-02
US61/361,209 2010-07-02
PCT/US2011/042838 WO2012003470A2 (en) 2010-07-02 2011-07-01 Antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015166305A Division JP2016026164A (ja) 2010-07-02 2015-08-26 抗体製剤

Publications (2)

Publication Number Publication Date
JP2013531679A true JP2013531679A (ja) 2013-08-08
JP2013531679A5 JP2013531679A5 (enExample) 2014-08-14

Family

ID=45402685

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2013518765A Pending JP2013531679A (ja) 2010-07-02 2011-07-01 抗体製剤
JP2015166305A Pending JP2016026164A (ja) 2010-07-02 2015-08-26 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2015166305A Pending JP2016026164A (ja) 2010-07-02 2015-08-26 抗体製剤

Country Status (9)

Country Link
US (1) US8754195B2 (enExample)
EP (1) EP2588141A4 (enExample)
JP (2) JP2013531679A (enExample)
CN (1) CN103108658B (enExample)
AU (2) AU2011274363A1 (enExample)
BR (1) BR112012033457A2 (enExample)
CA (1) CA2803998A1 (enExample)
SG (1) SG186421A1 (enExample)
WO (1) WO2012003470A2 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015520206A (ja) * 2012-06-21 2015-07-16 ユセベ ファルマ ソシエテ アノニム 医薬製剤
JP2016034939A (ja) * 2014-07-31 2016-03-17 キユーピー株式会社 含水エタノール製剤及びその製造方法、並びに、リゾチーム加工品及び／又はその塩並びにその製造方法

Families Citing this family (13)

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US8221753B2 (en) 2009-09-30 2012-07-17 Tracon Pharmaceuticals, Inc. Endoglin antibodies
TW201241008A (en) * 2010-10-01 2012-10-16 Alexion Pharma Inc Polypeptides that bind to human complement component C5
US20140004131A1 (en) 2012-05-04 2014-01-02 Novartis Ag Antibody formulation
UA115789C2 (uk) 2012-09-05 2017-12-26 Трейкон Фармасутікалз, Інк. Композиція антитіла до cd105 та її застосування
SI3049441T1 (sl) * 2013-09-27 2020-03-31 F. Hoffmann-La Roche Ag Formulacije protiteles proti PD-L1
WO2016077451A1 (en) 2014-11-12 2016-05-19 Tracon Pharmaceuticals, Inc. Anti-endoglin antibodies and uses thereof
US9926375B2 (en) 2014-11-12 2018-03-27 Tracon Pharmaceuticals, Inc. Anti-endoglin antibodies and uses thereof
EP3380525B1 (en) 2015-11-25 2023-11-08 Immunogen, Inc. Pharmaceutical formulations and methods of use thereof
EP3383435A4 (en) 2015-11-30 2019-07-10 Medimmune, LLC OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS
EA201891164A1 (ru) 2015-12-16 2018-11-30 Ридженерон Фармасьютикалз, Инк. Композиции и способы получения белковых микрочастиц
CN105920600A (zh) * 2016-04-19 2016-09-07 上海景泽生物技术有限公司 一种稳定的抗vegf抗体制剂及其用途
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
JP2024502825A (ja) 2020-12-30 2024-01-23 エーマックス バイオ， インコーポレイテッド 抗体の局所的延長放出

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001503781A (ja) * 1996-11-19 2001-03-21 ロシュ ダイアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤
JP2002504907A (ja) * 1997-06-13 2002-02-12 ジェネンテク，インコーポレイテッド 抗体製剤
JP2004532798A (ja) * 2000-10-12 2004-10-28 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
JP2008546699A (ja) * 2005-06-15 2008-12-25 シェーリング コーポレイション 抗ｉｇｆ１ｒ抗体処方物
JP2009501141A (ja) * 2005-06-17 2009-01-15 イムクローン システムズ インコーポレイテッド 転移性骨癌の治療のための受容体アンタゴニスト
JP2009540015A (ja) * 2006-06-14 2009-11-19 イムクローン・リミテッド・ライアビリティ・カンパニー 抗ｅｇｆｒ抗体の凍結乾燥製剤
JP2010505852A (ja) * 2006-10-06 2010-02-25 アムジエン・インコーポレーテツド 安定な抗体製剤

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US5468468A (en) 1989-02-09 1995-11-21 The United States Of America, As Represented By The Secretary Of The Department Of Health & Human Services Method for making a monoclonal antibody, monoclonal antibodies to α PD
EP0456766B1 (en) 1989-02-09 1999-04-28 The United States Of America TYPE oc PLATELET-DERIVED GROWTH FACTOR RECEPTOR GENE
DK0584082T3 (da) 1991-01-31 2000-10-16 Univ California Domæner i den ekstracellulære region af humane blodpladeafledte vækstfaktorreceptorpolypeptider
IE920318A1 (en) 1991-01-31 1992-07-29 Univ California Human platelet-derived growth factor receptors
US5444151A (en) 1992-05-15 1995-08-22 Ludwig Institute For Cancer Research Platelet derived growth factor antagonists
PT1516628E (pt) * 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US5882644A (en) 1996-03-22 1999-03-16 Protein Design Labs, Inc. Monoclonal antibodies specific for the platelet derived growth factor β receptor and methods of use thereof
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
AU4592601A (en) 2000-03-21 2001-10-03 Millennium Predictive Medicine Novel genes, compositions, kits, and method for identification, assessment, prevention, and therapy of ovarian cancer
WO2003009817A2 (en) * 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
WO2003068260A1 (fr) * 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
MXPA05005925A (es) 2002-12-02 2006-02-08 Abgenix Inc Anticuerpos dirigidos a la fosfolipasa a2 y sus usos.
AR045563A1 (es) 2003-09-10 2005-11-02 Warner Lambert Co Anticuerpos dirigidos a m-csf
US20080199438A1 (en) 2004-03-16 2008-08-21 Dnavec Research Inc. Methods For Suppressing Tumor Proliferation
CL2007002225A1 (es) * 2006-08-03 2008-04-18 Astrazeneca Ab Agente de union especifico para un receptor del factor de crecimiento derivado de plaquetas (pdgfr-alfa); molecula de acido nucleico que lo codifica; vector y celula huesped que la comprenden; conjugado que comprende al agente; y uso del agente de un
US20080153818A1 (en) * 2006-12-21 2008-06-26 Bingaman David P Methods for preventing inflammation during surgery

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001503781A (ja) * 1996-11-19 2001-03-21 ロシュ ダイアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング モノクローナル抗体又はポリクローナル抗体の安定な凍結乾燥された医薬製剤
JP2002504907A (ja) * 1997-06-13 2002-02-12 ジェネンテク，インコーポレイテッド 抗体製剤
JP2004532798A (ja) * 2000-10-12 2004-10-28 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
JP2008546699A (ja) * 2005-06-15 2008-12-25 シェーリング コーポレイション 抗ｉｇｆ１ｒ抗体処方物
JP2009501141A (ja) * 2005-06-17 2009-01-15 イムクローン システムズ インコーポレイテッド 転移性骨癌の治療のための受容体アンタゴニスト
JP2009540015A (ja) * 2006-06-14 2009-11-19 イムクローン・リミテッド・ライアビリティ・カンパニー 抗ｅｇｆｒ抗体の凍結乾燥製剤
JP2010505852A (ja) * 2006-10-06 2010-02-25 アムジエン・インコーポレーテツド 安定な抗体製剤

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015520206A (ja) * 2012-06-21 2015-07-16 ユセベ ファルマ ソシエテ アノニム 医薬製剤
JP2016034939A (ja) * 2014-07-31 2016-03-17 キユーピー株式会社 含水エタノール製剤及びその製造方法、並びに、リゾチーム加工品及び／又はその塩並びにその製造方法

Also Published As

Publication number Publication date
CA2803998A1 (en) 2012-01-05
AU2016201291A1 (en) 2016-03-17
CN103108658A (zh) 2013-05-15
JP2016026164A (ja) 2016-02-12
US20120009199A1 (en) 2012-01-12
US8754195B2 (en) 2014-06-17
WO2012003470A2 (en) 2012-01-05
CN103108658B (zh) 2015-08-19
BR112012033457A2 (pt) 2017-04-04
EP2588141A4 (en) 2014-12-03
WO2012003470A3 (en) 2012-02-23
SG186421A1 (en) 2013-01-30
EP2588141A2 (en) 2013-05-08
AU2011274363A1 (en) 2013-01-24

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