AU2013336279B2 - Stable pharmaceutical composition of TNFR:Fc fusion protein - Google Patents
Stable pharmaceutical composition of TNFR:Fc fusion protein Download PDFInfo
- Publication number
- AU2013336279B2 AU2013336279B2 AU2013336279A AU2013336279A AU2013336279B2 AU 2013336279 B2 AU2013336279 B2 AU 2013336279B2 AU 2013336279 A AU2013336279 A AU 2013336279A AU 2013336279 A AU2013336279 A AU 2013336279A AU 2013336279 B2 AU2013336279 B2 AU 2013336279B2
- Authority
- AU
- Australia
- Prior art keywords
- composition
- etanercept
- pharmaceutical composition
- phosphate
- tnfr
- 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.)
- Active
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Classifications
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- C—CHEMISTRY; METALLURGY
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- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
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- C—CHEMISTRY; METALLURGY
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Landscapes
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- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Cell Biology (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Rheumatology (AREA)
- Toxicology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Applications Claiming Priority (5)
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| IN1236/KOL/2012 | 2012-10-26 | ||
| IN1235KO2012 | 2012-10-26 | ||
| IN1236KO2012 | 2012-10-26 | ||
| IN1235/KOL/2012 | 2012-10-26 | ||
| PCT/IB2013/059612 WO2014064637A1 (en) | 2012-10-26 | 2013-10-24 | Stable pharmaceutical composition of tnfr:fc fusion protein |
Publications (2)
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| AU2013336279A1 AU2013336279A1 (en) | 2015-05-14 |
| AU2013336279B2 true AU2013336279B2 (en) | 2018-07-19 |
Family
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| AU2013336279A Active AU2013336279B2 (en) | 2012-10-26 | 2013-10-24 | Stable pharmaceutical composition of TNFR:Fc fusion protein |
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| EP (1) | EP2919801B1 (enExample) |
| JP (1) | JP6431844B2 (enExample) |
| KR (1) | KR102132050B1 (enExample) |
| CN (1) | CN104936607A (enExample) |
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| BR (1) | BR112015009462A2 (enExample) |
| CA (1) | CA2889271A1 (enExample) |
| ES (1) | ES2806946T3 (enExample) |
| MX (1) | MX366622B (enExample) |
| PL (1) | PL2919801T3 (enExample) |
| PT (1) | PT2919801T (enExample) |
| RU (1) | RU2664691C2 (enExample) |
| WO (1) | WO2014064637A1 (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP1909831A4 (en) | 2005-06-14 | 2013-02-20 | Amgen Inc | SELF-BUFFING PROTEIN FORMULATIONS |
| JP2016518386A (ja) * | 2013-05-02 | 2016-06-23 | マブキシェンス エス．アー． | ＴＮＦＲ：Ｆｃ融合ポリペプチドの代替配合物 |
| JP6480154B2 (ja) * | 2014-11-06 | 2019-03-06 | 持田製薬株式会社 | エタネルセプトの凍結乾燥製剤 |
| MX389818B (es) * | 2015-08-13 | 2025-03-20 | Landsteiner Scient S A De C V | Composicion de estabilidad mejorada de etanercept. |
| ES2962373T3 (es) * | 2016-04-13 | 2024-03-18 | Medimmune Llc | Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas |
| AU2017345490B2 (en) | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| CA3071930A1 (en) | 2017-08-08 | 2019-02-14 | Csl Behring Ag | Hemopexin formulations |
| US11253569B2 (en) | 2018-05-03 | 2022-02-22 | Seattle Children's Hospital | Methods of treating Kawasaki Disease |
| WO2022264097A1 (en) | 2021-06-17 | 2022-12-22 | Lupin Limited | Pharmaceutical composition of anti-tumour necrosis factor (anti-tnf) agent for management of infectious diseases caused by coronaviruses |
Citations (2)
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| WO2011141926A2 (en) * | 2010-05-10 | 2011-11-17 | Intas Biopharmaceuticals Limited | Liquid formulation of polypeptides containing an fc domain of an immunoglobulin |
| WO2012065072A2 (en) * | 2010-11-11 | 2012-05-18 | Abbott Biotechnology Ltd. | IMPROVED HIGH CONCENTRATION ANTI-TNFα ANTIBODY LIQUID FORMULATIONS |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5215743A (en) | 1988-04-13 | 1993-06-01 | Maninder Singh | Tumor necrosis factor formulations |
| US5997856A (en) * | 1988-10-05 | 1999-12-07 | Chiron Corporation | Method and compositions for solubilization and stabilization of polypeptides, especially proteins |
| DE4239877C1 (de) * | 1992-11-27 | 1994-03-17 | Boehringer Ingelheim Int | Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung |
| CA2304808C (en) * | 1997-09-23 | 2011-03-22 | Michael Tschope | Liquid interferon-.beta. formulations |
| US20030180287A1 (en) * | 2002-02-27 | 2003-09-25 | Immunex Corporation | Polypeptide formulation |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| ES2304602T3 (es) | 2003-02-28 | 2008-10-16 | Ares Trading S.A. | Formulaciones liquidas de la proteina de union al factor de necrosis tumoral tbp-1. |
| ES2310122B1 (es) * | 2007-04-20 | 2009-10-30 | Instituto Cientifico Y Tecnologico De Navarra, S.A | Nanoparticulas que comprenden una ciclodextrina y una molecula biologicamente activa y sus aplicaciones. |
| US9296806B2 (en) * | 2008-04-30 | 2016-03-29 | Wockhardt Limited | Processes for refolding of insulin |
| NZ613809A (en) * | 2009-05-04 | 2015-02-27 | Abbvie Biotechnology Ltd | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| US9453067B2 (en) * | 2011-04-20 | 2016-09-27 | Sandoz Ag | Stable pharmaceutical liquid formulations of the fusion protein TNFR:Fc |
-
2013
- 2013-10-24 PL PL13795585T patent/PL2919801T3/pl unknown
- 2013-10-24 MX MX2015005231A patent/MX366622B/es active IP Right Grant
- 2013-10-24 CN CN201380062888.5A patent/CN104936607A/zh active Pending
- 2013-10-24 PT PT137955852T patent/PT2919801T/pt unknown
- 2013-10-24 CA CA2889271A patent/CA2889271A1/en not_active Abandoned
- 2013-10-24 EP EP13795585.2A patent/EP2919801B1/en active Active
- 2013-10-24 AU AU2013336279A patent/AU2013336279B2/en active Active
- 2013-10-24 KR KR1020157012856A patent/KR102132050B1/ko not_active Expired - Fee Related
- 2013-10-24 WO PCT/IB2013/059612 patent/WO2014064637A1/en not_active Ceased
- 2013-10-24 RU RU2015119603A patent/RU2664691C2/ru active
- 2013-10-24 JP JP2015538612A patent/JP6431844B2/ja not_active Expired - Fee Related
- 2013-10-24 BR BR112015009462A patent/BR112015009462A2/pt not_active IP Right Cessation
- 2013-10-24 US US14/438,404 patent/US10058589B2/en active Active
- 2013-10-24 ES ES13795585T patent/ES2806946T3/es active Active
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2018
- 2018-04-23 US US15/959,650 patent/US20180236030A1/en not_active Abandoned
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011141926A2 (en) * | 2010-05-10 | 2011-11-17 | Intas Biopharmaceuticals Limited | Liquid formulation of polypeptides containing an fc domain of an immunoglobulin |
| WO2012065072A2 (en) * | 2010-11-11 | 2012-05-18 | Abbott Biotechnology Ltd. | IMPROVED HIGH CONCENTRATION ANTI-TNFα ANTIBODY LIQUID FORMULATIONS |
Non-Patent Citations (2)
| Title |
|---|
| Anonymous, "Enbrel, INN etanercept", (20090911), pages 184 - 185, European Medicines Agency, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000262/WC500027361.pdf, (retrieved 14/07/2017) * |
| YOSHIKO KITA ET AL, "Salts and Glycine Increase Reversibility and Decrease Aggregation during Thermal Unfolding of Ribonuclease-A.", BIOSCIENCE, BIOTECHNOLOGY, AND BIOCHEMISTRY, (20020101), vol. 66, no. 4, , pages 880 - 882 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2889271A1 (en) | 2014-05-01 |
| KR20150074069A (ko) | 2015-07-01 |
| EP2919801A1 (en) | 2015-09-23 |
| US20150283241A1 (en) | 2015-10-08 |
| RU2015119603A (ru) | 2016-12-20 |
| ES2806946T3 (es) | 2021-02-19 |
| PL2919801T3 (pl) | 2021-01-25 |
| US10058589B2 (en) | 2018-08-28 |
| JP6431844B2 (ja) | 2018-11-28 |
| MX366622B (es) | 2019-07-16 |
| AU2013336279A1 (en) | 2015-05-14 |
| JP2015535237A (ja) | 2015-12-10 |
| RU2664691C2 (ru) | 2018-08-21 |
| EP2919801B1 (en) | 2020-04-29 |
| BR112015009462A2 (pt) | 2017-07-04 |
| WO2014064637A1 (en) | 2014-05-01 |
| MX2015005231A (es) | 2015-10-29 |
| CN104936607A (zh) | 2015-09-23 |
| US20180236030A1 (en) | 2018-08-23 |
| PT2919801T (pt) | 2020-07-30 |
| KR102132050B1 (ko) | 2020-07-10 |
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