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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Japan
Prior art keywords
formulation
polypeptide
antibody
dmso
dma
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JP2012523701A
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Japanese (ja)
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JP2013501058A5 (cg-RX-API-DMAC10.html
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
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
    • A61K9/08—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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], 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)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Endocrinology (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)

Publication Number Publication Date
JP2013501058A true JP2013501058A (ja) 2013-01-10
JP2013501058A5 JP2013501058A5 (cg-RX-API-DMAC10.html) 2013-09-12

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Family Applications (1)

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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

Country Status (15)

Country Link
US (1) US20130236448A1 (cg-RX-API-DMAC10.html)
EP (1) EP2461677A4 (cg-RX-API-DMAC10.html)
JP (1) JP2013501058A (cg-RX-API-DMAC10.html)
KR (1) KR20120047995A (cg-RX-API-DMAC10.html)
CN (1) CN102573459A (cg-RX-API-DMAC10.html)
AU (1) AU2010279569A1 (cg-RX-API-DMAC10.html)
BR (1) BR112012002596A2 (cg-RX-API-DMAC10.html)
CA (1) CA2769221A1 (cg-RX-API-DMAC10.html)
IL (1) IL217887A0 (cg-RX-API-DMAC10.html)
MX (1) MX2012001560A (cg-RX-API-DMAC10.html)
NZ (1) NZ598518A (cg-RX-API-DMAC10.html)
RU (1) RU2012108108A (cg-RX-API-DMAC10.html)
SG (1) SG178226A1 (cg-RX-API-DMAC10.html)
WO (1) WO2011017330A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201200760B (cg-RX-API-DMAC10.html)

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 (9)

* 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.
CN107837395A (zh) 2011-02-09 2018-03-27 葛兰素史密斯克莱有限责任公司 冻干制剂
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
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
IL307684B2 (en) 2016-09-29 2025-04-01 Amgen Inc Low viscosity antigen binding proteins and methods for preparing them
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR013202A1 (es) * 1997-07-10 2000-12-13 Biotech Australia Pty Ltd Vacunas no acuosas
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
GB0412530D0 (en) * 2004-06-04 2004-07-07 Camurus Ab Formulation
PL1768650T3 (pl) * 2004-06-04 2009-01-30 Camurus Ab Ciekłe formulacje depot
EP1909824B1 (en) * 2005-04-08 2011-05-18 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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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

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

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