JPWO2005063291A1 - 抗体を含有する安定な水性医薬製剤 - Google Patents
抗体を含有する安定な水性医薬製剤 Download PDFInfo
- Publication number
- JPWO2005063291A1 JPWO2005063291A1 JP2005516616A JP2005516616A JPWO2005063291A1 JP WO2005063291 A1 JPWO2005063291 A1 JP WO2005063291A1 JP 2005516616 A JP2005516616 A JP 2005516616A JP 2005516616 A JP2005516616 A JP 2005516616A JP WO2005063291 A1 JPWO2005063291 A1 JP WO2005063291A1
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- aqueous pharmaceutical
- pharmaceutical preparation
- preparation according
- stable
- 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.)
- Pending
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Classifications
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2003431400 | 2003-12-25 | ||
| JP2003431400 | 2003-12-25 | ||
| PCT/JP2004/019259 WO2005063291A1 (ja) | 2003-12-25 | 2004-12-22 | 抗体を含有する安定な水性医薬製剤 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPWO2005063291A1 true JPWO2005063291A1 (ja) | 2007-07-19 |
Family
ID=34736431
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2005516616A Pending JPWO2005063291A1 (ja) | 2003-12-25 | 2004-12-22 | 抗体を含有する安定な水性医薬製剤 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20070184050A1 (https=) |
| EP (1) | EP1712240B1 (https=) |
| JP (1) | JPWO2005063291A1 (https=) |
| ES (1) | ES2553987T3 (https=) |
| TW (1) | TW200526247A (https=) |
| WO (1) | WO2005063291A1 (https=) |
Families Citing this family (53)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160279239A1 (en) | 2011-05-02 | 2016-09-29 | Immunomedics, Inc. | Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease |
| US20160355591A1 (en) | 2011-05-02 | 2016-12-08 | Immunomedics, Inc. | Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies |
| MX2007015476A (es) | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| AR059066A1 (es) | 2006-01-27 | 2008-03-12 | Amgen Inc | Combinaciones del inhibidor de la angiopoyetina -2 (ang2) y el inhibidor del factor de crecimiento endotelial vascular (vegf) |
| MX2008013508A (es) * | 2006-04-21 | 2008-10-31 | Novartis Ag | Composiciones farmaceuticas de anticuerpos antagonistas anti-cd40. |
| JP2009534390A (ja) * | 2006-04-21 | 2009-09-24 | アムジェン インコーポレイテッド | 生物医薬品製剤のための緩衝剤 |
| US7833527B2 (en) | 2006-10-02 | 2010-11-16 | Amgen Inc. | Methods of treating psoriasis using IL-17 Receptor A antibodies |
| EP2081553B1 (en) * | 2006-10-06 | 2020-08-12 | Amgen Inc. | Stable antibody formulations |
| CN101557799B (zh) * | 2006-12-05 | 2012-08-22 | 克鲁塞尔荷兰公司 | 液体抗狂犬病抗体制剂 |
| JP5577098B2 (ja) * | 2006-12-21 | 2014-08-20 | アムジエン・インコーポレーテツド | ポリペプチドを含有する安定な緩衝化された製剤 |
| EP2170268A2 (en) | 2007-06-25 | 2010-04-07 | Amgen, Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| US9308257B2 (en) | 2007-11-28 | 2016-04-12 | Medimmune, Llc | Protein formulation |
| TWI543768B (zh) * | 2007-11-30 | 2016-08-01 | 艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| WO2010062896A1 (en) * | 2008-11-28 | 2010-06-03 | Abbott Laboratories | Stable antibody compositions and methods for stabilizing same |
| MX2011011772A (es) * | 2009-05-04 | 2012-02-08 | Abbott Biotech Ltd | Formulaicones estables de anticuerpos humanos anti-tnf-alfa con alta concentracion de proteina. |
| HRP20171939T1 (hr) | 2010-01-15 | 2018-03-23 | Kirin-Amgen, Inc. | Formulacija protutijela i režimi terapije |
| US20120294866A1 (en) * | 2010-01-19 | 2012-11-22 | F. Hoffmann-La Roche Ag | Pharmaceutical formulation for proteins |
| AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| BR112012021576A2 (pt) | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| RU2012153786A (ru) | 2010-05-28 | 2014-07-10 | Ново Нордиск А/С | Стабильные многодозовые композиции, содержащие антитело и консервант |
| SG190069A1 (en) | 2010-11-11 | 2013-06-28 | Abbvie Biotechnology Ltd | IMPROVED HIGH CONCENTRATION ANTI-TNFa ANTIBODY LIQUID FORMULATIONS |
| EP2471554A1 (en) * | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| JP5458188B2 (ja) * | 2011-02-17 | 2014-04-02 | 協和発酵キリン株式会社 | 抗cd40抗体の高濃度製剤 |
| AU2012250924B2 (en) | 2011-05-02 | 2017-05-25 | Immunomedics, Inc. | Ultrafiltration concentration of allotype selected antibodies for small-volume administration |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| DK2884996T3 (da) * | 2012-08-17 | 2020-03-09 | Intervet Int Bv | Immunogen sammensætning af dræbte leptospira-bakterier |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| WO2014039903A2 (en) | 2012-09-07 | 2014-03-13 | Coherus Biosciences, Inc. | Stable aqueous formulations of adalimumab |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| CN106390115A (zh) * | 2015-07-29 | 2017-02-15 | 上海君实生物医药科技股份有限公司 | 一种人源化单克隆抗体的稳定制剂 |
| LT4209499T (lt) | 2015-08-13 | 2024-11-25 | Amgen Inc. | Antigeną surišančių baltymų įkrautas giluminis filtravimas |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| JPWO2017164349A1 (ja) * | 2016-03-25 | 2019-02-07 | 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 |
| WO2017184880A1 (en) | 2016-04-20 | 2017-10-26 | Coherus Biosciences, Inc. | A method of filling a container with no headspace |
| MA44780A (fr) | 2016-04-28 | 2019-03-06 | Chugai Pharmaceutical Co Ltd | Préparation contenant un anticorps |
| SG11201908091QA (en) * | 2017-03-06 | 2019-10-30 | Merck Patent Gmbh | Aqueous anti-pd-l1 antibody formulation |
| WO2018187074A1 (en) | 2017-04-03 | 2018-10-11 | Immunomedics, Inc. | Subcutaneous administration of antibody-drug conjugates for cancer therapy |
| AU2018263868A1 (en) | 2017-05-02 | 2019-12-12 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| AU2018361430B2 (en) | 2017-11-01 | 2025-08-14 | Chugai Seiyaku Kabushiki Kaisha | Antibody variant and isoform with lowered biological activity |
| KR102885113B1 (ko) | 2018-10-18 | 2025-11-13 | 머크 샤프 앤드 돔 엘엘씨 | 항-rsv 항체의 제제 및 그의 사용 방법 |
| CN120842406A (zh) | 2018-10-31 | 2025-10-28 | 默沙东有限责任公司 | 抗人pd-1抗体晶体及其使用方法 |
| CN113316458B (zh) | 2018-11-07 | 2024-08-02 | 默沙东有限责任公司 | 抗lag3抗体和抗pd-1抗体的共制剂 |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| CU20190104A7 (es) * | 2019-12-17 | 2021-08-06 | Ct Inmunologia Molecular | Formulación estable del anticuerpo nimotuzumab |
| KR20230010239A (ko) * | 2020-05-11 | 2023-01-18 | 메디뮨 리미티드 | 항-il-33 항체의 제형물 |
| AU2021278562A1 (en) | 2020-05-29 | 2022-12-01 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing formulation |
| CA3208339A1 (en) * | 2021-02-17 | 2022-08-25 | David Leonard BIENVENUE | Compositions comprising 4-1bb and ox40 binding proteins and methods of use |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2547556B2 (ja) * | 1987-02-06 | 1996-10-23 | 株式会社 ミドリ十字 | r−グロブリンの液状製剤 |
| JPH0565233A (ja) * | 1991-03-08 | 1993-03-19 | Mitsui Toatsu Chem Inc | モノクローナル抗体含有凍結乾燥製剤 |
| GB9122820D0 (en) * | 1991-10-28 | 1991-12-11 | Wellcome Found | Stabilised antibodies |
| JP2942412B2 (ja) * | 1991-12-26 | 1999-08-30 | 鐘紡株式会社 | 化粧料 |
| US5397703A (en) * | 1992-07-09 | 1995-03-14 | Cetus Oncology Corporation | Method for generation of antibodies to cell surface molecules |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| EP0999853B1 (en) * | 1997-06-13 | 2003-01-02 | Genentech, Inc. | Stabilized antibody formulation |
| AU2444899A (en) * | 1998-01-22 | 1999-08-09 | Astrazeneca Ab | Pharmaceutical formulation comprising an antibody and a citrate buffer |
| AU5588099A (en) * | 1998-08-28 | 2000-03-21 | Dendreon Corporation | Selective apoptosis of neoplastic cells by an hla-dr specific monoclonal antibody |
| CA2371427A1 (en) * | 1999-04-28 | 2000-11-09 | Yamanouchi Pharmaceutical Co., Ltd. | Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof |
| DE60031999T2 (de) * | 1999-10-04 | 2007-06-06 | Novartis Vaccines and Diagnostics, Inc., Emeryville | Stabilisierte flüssige polypeptid-haltige pharmazeutische zusammensetzungen |
| JP4516711B2 (ja) * | 1999-12-28 | 2010-08-04 | 中外製薬株式会社 | 安定な抗体組成物及び注射製剤 |
| AU2002213441B2 (en) * | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| GB0113179D0 (en) * | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
| EP1428537B1 (en) * | 2001-08-29 | 2008-11-19 | Chugai Seiyaku Kabushiki Kaisha | Stabilized preparations containing antibody |
| AU2003211990A1 (en) * | 2002-02-14 | 2003-09-04 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing solution pharmaceuticals |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
-
2004
- 2004-12-22 WO PCT/JP2004/019259 patent/WO2005063291A1/ja not_active Ceased
- 2004-12-22 ES ES04807616.0T patent/ES2553987T3/es not_active Expired - Lifetime
- 2004-12-22 EP EP04807616.0A patent/EP1712240B1/en not_active Expired - Lifetime
- 2004-12-22 JP JP2005516616A patent/JPWO2005063291A1/ja active Pending
- 2004-12-22 US US10/584,249 patent/US20070184050A1/en not_active Abandoned
- 2004-12-24 TW TW093140584A patent/TW200526247A/zh not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| US20070184050A1 (en) | 2007-08-09 |
| EP1712240B1 (en) | 2015-09-09 |
| ES2553987T3 (es) | 2015-12-15 |
| TW200526247A (en) | 2005-08-16 |
| EP1712240A4 (en) | 2012-08-22 |
| WO2005063291A1 (ja) | 2005-07-14 |
| TWI353253B (https=) | 2011-12-01 |
| EP1712240A1 (en) | 2006-10-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A711 | Notification of change in applicant |
Free format text: JAPANESE INTERMEDIATE CODE: A712 Effective date: 20070816 |
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| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20071113 |
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| A711 | Notification of change in applicant |
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| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20110301 |
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| A521 | Request for written amendment filed |
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| A02 | Decision of refusal |
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