JP5577098B2 - ポリペプチドを含有する安定な緩衝化された製剤 - Google Patents
ポリペプチドを含有する安定な緩衝化された製剤 Download PDFInfo
- Publication number
- JP5577098B2 JP5577098B2 JP2009542922A JP2009542922A JP5577098B2 JP 5577098 B2 JP5577098 B2 JP 5577098B2 JP 2009542922 A JP2009542922 A JP 2009542922A JP 2009542922 A JP2009542922 A JP 2009542922A JP 5577098 B2 JP5577098 B2 JP 5577098B2
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- JP
- Japan
- Prior art keywords
- formulation
- antibody
- formulations
- concentration
- buffer
- Prior art date
- Legal status (The legal status 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 status listed.)
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Classifications
-
- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- 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
- A61K47/16—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
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US87680106P | 2006-12-21 | 2006-12-21 | |
| US60/876,801 | 2006-12-21 | ||
| PCT/US2007/026060 WO2008079290A2 (en) | 2006-12-21 | 2007-12-19 | Stable buffered formulations containing polypeptides |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013109920A Division JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2010513522A JP2010513522A (ja) | 2010-04-30 |
| JP2010513522A5 JP2010513522A5 (cg-RX-API-DMAC7.html) | 2011-02-10 |
| JP5577098B2 true JP5577098B2 (ja) | 2014-08-20 |
Family
ID=39563088
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009542922A Active JP5577098B2 (ja) | 2006-12-21 | 2007-12-19 | ポリペプチドを含有する安定な緩衝化された製剤 |
| JP2013109920A Pending JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013109920A Pending JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (3) | US20080213282A1 (cg-RX-API-DMAC7.html) |
| EP (1) | EP2129401B8 (cg-RX-API-DMAC7.html) |
| JP (2) | JP5577098B2 (cg-RX-API-DMAC7.html) |
| AU (1) | AU2007338791B2 (cg-RX-API-DMAC7.html) |
| CA (2) | CA2790018C (cg-RX-API-DMAC7.html) |
| ES (1) | ES2748526T3 (cg-RX-API-DMAC7.html) |
| MX (1) | MX2009006594A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2008079290A2 (cg-RX-API-DMAC7.html) |
Families Citing this family (49)
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| ITRM20030601A1 (it) | 2003-12-24 | 2005-06-25 | Lay Line Genomics Spa | Metodo per l'umanizzazione di anticorpi e anticorpi umanizzati con esso ottenuti. |
| ITRM20050290A1 (it) | 2005-06-07 | 2006-12-08 | Lay Line Genomics Spa | Uso di molecole in grado di inibire il legame tra ngf e il suo recettore trka come analgesici ad effetto prolungato. |
| MX2007015476A (es) | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| US7767206B2 (en) | 2006-10-02 | 2010-08-03 | Amgen Inc. | Neutralizing determinants of IL-17 Receptor A and antibodies that bind thereto |
| KR101593285B1 (ko) * | 2008-10-29 | 2016-02-11 | 아블린쓰 엔.브이. | 단일 도메인 항원 결합 분자의 제형 |
| US10005830B2 (en) | 2009-03-05 | 2018-06-26 | Ablynx N.V. | Antigen binding dimer-complexes, methods of making/avoiding and uses thereof |
| US9265834B2 (en) | 2009-03-05 | 2016-02-23 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| EP2448970B1 (en) * | 2009-05-04 | 2014-07-09 | Abbott Research B.V. | Antibodies against nerve growth factor (ngf) with enhanced in vivo stability |
| TWI558422B (zh) | 2009-05-27 | 2016-11-21 | 阿艾克麥斯製藥愛爾蘭有限公司 | 減少奈米顆粒活性劑組成物中薄片狀聚集之技術 |
| WO2010144265A2 (en) * | 2009-06-12 | 2010-12-16 | Helsinn Therapeutics (U.S.), Inc. | Ipamorelin diacetate injection and infusion solutions |
| EP2805731B1 (en) | 2009-09-03 | 2018-10-31 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| PT3295957T (pt) | 2010-01-15 | 2019-11-12 | Kirin Amgen Inc | Formulação de anticorpo anti il-17ra e regimes terapêuticos para o tratamento de psoríase |
| AR080428A1 (es) * | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| EP2694100A4 (en) * | 2011-04-07 | 2014-10-01 | Glaxosmithkline Llc | FORMULATIONS HAVING REDUCED VISCOSITY |
| CN104010658A (zh) | 2011-10-18 | 2014-08-27 | 科荣生生物科学公司 | 使用葡甲胺稳定的依那西普制剂 |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| EP2771297B1 (en) | 2011-10-25 | 2017-12-13 | Corning Incorporated | Delamination resistant pharmaceuticals glass containers containing active pharmaceutical ingredients |
| BR112014010186A2 (pt) | 2011-10-28 | 2017-05-02 | Integritybio Inc | formulação farmacêutica estável, kit, composição farmacêutica, método para preparar uma formulação farmacêutica, e, método para tratar um humano ou animal |
| EP2869817A4 (en) | 2012-07-09 | 2016-04-06 | Coherus Biosciences Inc | STABLE AQUEOUS FORMULATIONS OF ETANERCEPT |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| AU2013315750B9 (en) | 2012-09-11 | 2018-11-15 | Coherus Biosciences, Inc. | Correctly folded etanercept in high purity and excellent yield |
| US9713572B2 (en) | 2013-04-24 | 2017-07-25 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707154B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707155B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9700485B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9717649B2 (en) * | 2013-04-24 | 2017-08-01 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9849066B2 (en) | 2013-04-24 | 2017-12-26 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707153B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9839579B2 (en) | 2013-04-24 | 2017-12-12 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9700486B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9603775B2 (en) | 2013-04-24 | 2017-03-28 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9717648B2 (en) | 2013-04-24 | 2017-08-01 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| GB2516808A (en) * | 2013-05-31 | 2015-02-11 | Innova Biosciences Ltd | Antibody composition and buffer system therefor |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| PT3380525T (pt) | 2015-11-25 | 2024-02-05 | Immunogen Inc | Formulações farmacêuticas e métodos que as utilizam |
| WO2017164349A1 (ja) * | 2016-03-25 | 2017-09-28 | アステラス製薬株式会社 | PEG化抗ヒトNGF抗体Fab'フラグメント含有医薬組成物 |
| EP3443346B1 (en) * | 2016-04-13 | 2023-08-30 | Medimmune, LLC | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| PL3468997T3 (pl) * | 2016-06-08 | 2024-12-16 | Xencor, Inc. | Leczenie chorób związanych z lgG4 przeciwciałami anty-CD19 wiążącymi się krzyżowo z CD32b |
| CA3040899A1 (en) | 2016-10-21 | 2018-04-26 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| WO2018200533A1 (en) | 2017-04-28 | 2018-11-01 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| JOP20190255A1 (ar) * | 2017-04-28 | 2019-10-27 | Amgen Inc | صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| JP7382232B2 (ja) | 2017-05-02 | 2023-11-16 | メルク・シャープ・アンド・ドーム・エルエルシー | 抗lag3抗体の製剤および抗lag3抗体と抗pd-1抗体との共製剤 |
| CA3089906A1 (en) * | 2018-02-08 | 2019-08-15 | Amgen Inc. | Low ph pharmaceutical antibody formulation |
| MX2021005394A (es) | 2018-11-07 | 2021-07-06 | Merck Sharp & Dohme Llc | Co-formulaciones de anticuerpos anti-gen de activacion de linfocitos 3 (anti-lag3) y anticuerpos anti-muerte programada-1 (anti-pd-1). |
| CN113365658A (zh) * | 2018-11-16 | 2021-09-07 | 三星Bioepis股份有限公司 | 包含蛋白质的稳定的液体组合物 |
| JOP20210229A1 (ar) | 2019-02-18 | 2023-01-30 | Lilly Co Eli | صيغة جسم مضاد علاجي |
| TW202108171A (zh) * | 2019-04-23 | 2021-03-01 | 法商賽諾菲公司 | 穩定的低黏度抗體調配物及其用途 |
| US20220031812A1 (en) * | 2020-07-30 | 2022-02-03 | Silver Creek Pharmaceuticals, Inc. | Chimeric Proteins and Methods of Use for Treatment of Central Nervous System Disorders |
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| MX2007015476A (es) * | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
-
2007
- 2007-12-19 EP EP07863175.1A patent/EP2129401B8/en active Active
- 2007-12-19 WO PCT/US2007/026060 patent/WO2008079290A2/en not_active Ceased
- 2007-12-19 ES ES07863175T patent/ES2748526T3/es active Active
- 2007-12-19 CA CA2790018A patent/CA2790018C/en active Active
- 2007-12-19 AU AU2007338791A patent/AU2007338791B2/en active Active
- 2007-12-19 JP JP2009542922A patent/JP5577098B2/ja active Active
- 2007-12-19 CA CA2672902A patent/CA2672902C/en active Active
- 2007-12-19 US US12/004,114 patent/US20080213282A1/en not_active Abandoned
- 2007-12-19 MX MX2009006594A patent/MX2009006594A/es active IP Right Grant
-
2013
- 2013-05-24 JP JP2013109920A patent/JP2013216659A/ja active Pending
-
2015
- 2015-05-05 US US14/704,853 patent/US20150315271A1/en not_active Abandoned
-
2019
- 2019-05-22 US US16/419,527 patent/US20190345238A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US20150315271A1 (en) | 2015-11-05 |
| MX2009006594A (es) | 2009-08-12 |
| AU2007338791B2 (en) | 2014-03-13 |
| JP2010513522A (ja) | 2010-04-30 |
| CA2672902C (en) | 2012-11-27 |
| CA2790018A1 (en) | 2008-07-03 |
| AU2007338791A1 (en) | 2008-07-03 |
| CA2790018C (en) | 2015-02-03 |
| EP2129401B8 (en) | 2020-01-15 |
| JP2013216659A (ja) | 2013-10-24 |
| EP2129401A2 (en) | 2009-12-09 |
| WO2008079290A3 (en) | 2008-12-04 |
| WO2008079290A2 (en) | 2008-07-03 |
| CA2672902A1 (en) | 2008-07-03 |
| ES2748526T3 (es) | 2020-03-17 |
| US20190345238A1 (en) | 2019-11-14 |
| US20080213282A1 (en) | 2008-09-04 |
| EP2129401B1 (en) | 2019-07-17 |
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