JP2013501058A - 低減された粘性を有する濃縮ポリペプチド製剤 - Google Patents

低減された粘性を有する濃縮ポリペプチド製剤 Download PDF

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Publication number
JP2013501058A
JP2013501058A JP2012523701A JP2012523701A JP2013501058A JP 2013501058 A JP2013501058 A JP 2013501058A JP 2012523701 A JP2012523701 A JP 2012523701A JP 2012523701 A JP2012523701 A JP 2012523701A JP 2013501058 A JP2013501058 A JP 2013501058A
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Prior art keywords
formulation
polypeptide
antibody
dmso
dma
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JP2012523701A
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Japanese (ja)
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JP2013501058A5 (enExample
Inventor
ティム カメルツェル，
シェリー マーティン−モエ，
ジョン， ユチャン ワン，
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ジェネンテック， インコーポレイテッド
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Publication of JP2013501058A publication Critical patent/JP2013501058A/ja
Publication of JP2013501058A5 publication Critical patent/JP2013501058A5/ja
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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
    • A61K9/08—Solutions
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/249—Interferons
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2012523701A 2009-08-04 2010-08-03 低減された粘性を有する濃縮ポリペプチド製剤 Pending JP2013501058A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US23114009P 2009-08-04 2009-08-04
US61/231,140 2009-08-04
PCT/US2010/044258 WO2011017330A1 (en) 2009-08-04 2010-08-03 Concentrated polypeptide formulations with reduced viscosity

Publications (2)

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JP2013501058A true JP2013501058A (ja) 2013-01-10
JP2013501058A5 JP2013501058A5 (enExample) 2013-09-12

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JP2012523701A Pending JP2013501058A (ja) 2009-08-04 2010-08-03 低減された粘性を有する濃縮ポリペプチド製剤

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Country Link
US (1) US20130236448A1 (enExample)
EP (1) EP2461677A4 (enExample)
JP (1) JP2013501058A (enExample)
KR (1) KR20120047995A (enExample)
CN (1) CN102573459A (enExample)
AU (1) AU2010279569A1 (enExample)
BR (1) BR112012002596A2 (enExample)
CA (1) CA2769221A1 (enExample)
IL (1) IL217887A0 (enExample)
MX (1) MX2012001560A (enExample)
NZ (1) NZ598518A (enExample)
RU (1) RU2012108108A (enExample)
SG (1) SG178226A1 (enExample)
WO (1) WO2011017330A1 (enExample)
ZA (1) ZA201200760B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017512750A (ja) * 2013-11-29 2017-05-25 ジェネンテック， インコーポレイテッド 抗体選択装置及び方法

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
KR20140044305A (ko) 2011-02-09 2014-04-14 글락소스미스클라인 엘엘씨 동결건조된 제제
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
WO2016019969A1 (en) 2014-08-08 2016-02-11 Ludwig-Maximilians-Universität München Subcutaneously administered bispecific antibodies for use in the treatment of cancer
MX391067B (es) 2014-10-01 2025-03-21 Eagle Biologics Inc Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad.
KR20210021299A (ko) 2018-05-10 2021-02-25 리제너론 파아마슈티컬스, 인크. 고농도 vegf 수용체 융합 단백질 함유 제제

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004532262A (ja) * 2001-05-31 2004-10-21 ノバルティス　アクチエンゲゼルシャフト 安定な抗体液体製剤
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
JP2005530845A (ja) * 2002-06-21 2005-10-13 アイデック ファーマシューティカルズ コーポレイション 抗体を濃縮するための緩衝化処方物およびその使用方法
JP2008503597A (ja) * 2004-06-14 2008-02-07 ユーエスブイ・リミテッド ペプチドの製造方法
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
WO1999002182A2 (en) * 1997-07-10 1999-01-21 Biotech Australia Pty. Limited Non-aqueous vaccines
US20050158303A1 (en) * 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
PL1768650T3 (pl) * 2004-06-04 2009-01-30 Camurus Ab Ciekłe formulacje depot
GB0412530D0 (en) * 2004-06-04 2004-07-07 Camurus Ab Formulation
WO2006110551A2 (en) * 2005-04-08 2006-10-19 Amylin Pharmaceuticals, Inc. Pharmaceutical formulations comprising incretin peptide and aprotic polar solvent

Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
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
JP2004532262A (ja) * 2001-05-31 2004-10-21 ノバルティス　アクチエンゲゼルシャフト 安定な抗体液体製剤
JP2005530845A (ja) * 2002-06-21 2005-10-13 アイデック ファーマシューティカルズ コーポレイション 抗体を濃縮するための緩衝化処方物およびその使用方法
JP2008503597A (ja) * 2004-06-14 2008-02-07 ユーエスブイ・リミテッド ペプチドの製造方法
JP2009521482A (ja) * 2005-12-21 2009-06-04 ワイス 低粘度のタンパク質製剤およびその用途

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Title
A. ABEDINI ET AL, ANALYTICAL BIOCHEMISTRY, vol. 351, JPN6014032098, 2006, pages 181 - 186, ISSN: 0002866226 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017512750A (ja) * 2013-11-29 2017-05-25 ジェネンテック， インコーポレイテッド 抗体選択装置及び方法

Also Published As

Publication number Publication date
MX2012001560A (es) 2012-06-01
ZA201200760B (en) 2013-05-29
NZ598518A (en) 2014-12-24
US20130236448A1 (en) 2013-09-12
SG178226A1 (en) 2012-03-29
EP2461677A4 (en) 2014-01-08
CN102573459A (zh) 2012-07-11
WO2011017330A8 (en) 2011-04-21
EP2461677A1 (en) 2012-06-13
AU2010279569A1 (en) 2012-03-01
IL217887A0 (en) 2012-03-29
BR112012002596A2 (pt) 2015-09-15
KR20120047995A (ko) 2012-05-14
CA2769221A1 (en) 2011-02-10
WO2011017330A1 (en) 2011-02-10
RU2012108108A (ru) 2013-09-10

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