JP6463968B2 - アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 - Google Patents
アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 Download PDFInfo
- Publication number
- JP6463968B2 JP6463968B2 JP2014519158A JP2014519158A JP6463968B2 JP 6463968 B2 JP6463968 B2 JP 6463968B2 JP 2014519158 A JP2014519158 A JP 2014519158A JP 2014519158 A JP2014519158 A JP 2014519158A JP 6463968 B2 JP6463968 B2 JP 6463968B2
- Authority
- JP
- Japan
- Prior art keywords
- composition
- concentration
- polypeptide
- arginine
- sucrose
- 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
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- 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
- C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- 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
- C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- 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
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/51—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 the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
-
- 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
- A61K47/02—Inorganic compounds
-
- 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]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/525—Tumour necrosis factor [TNF]
-
- 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
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Cell Biology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Toxicology (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161504110P | 2011-07-01 | 2011-07-01 | |
| US61/504,110 | 2011-07-01 | ||
| PCT/US2012/044988 WO2013006454A1 (en) | 2011-07-01 | 2012-06-29 | Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017098806A Division JP2017186349A (ja) | 2011-07-01 | 2017-05-18 | アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014518276A JP2014518276A (ja) | 2014-07-28 |
| JP2014518276A5 JP2014518276A5 (enExample) | 2015-08-13 |
| JP6463968B2 true JP6463968B2 (ja) | 2019-02-06 |
Family
ID=46579322
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014519158A Active JP6463968B2 (ja) | 2011-07-01 | 2012-06-29 | アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 |
| JP2017098806A Pending JP2017186349A (ja) | 2011-07-01 | 2017-05-18 | アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017098806A Pending JP2017186349A (ja) | 2011-07-01 | 2017-05-18 | アルギニンを含まない腫瘍壊死因子受容体：ｆｃ融合ポリペプチド組成物およびその使用方法 |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10995130B2 (enExample) |
| EP (1) | EP2726090B1 (enExample) |
| JP (2) | JP6463968B2 (enExample) |
| KR (1) | KR102061355B1 (enExample) |
| CN (2) | CN103930124B (enExample) |
| AU (2) | AU2012279205B2 (enExample) |
| BR (1) | BR112013033671B1 (enExample) |
| CA (1) | CA2840711C (enExample) |
| DK (1) | DK2726090T3 (enExample) |
| EA (1) | EA026226B1 (enExample) |
| MX (2) | MX421100B (enExample) |
| WO (1) | WO2013006454A1 (enExample) |
| ZA (1) | ZA201400490B (enExample) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3673919A1 (en) | 2005-06-14 | 2020-07-01 | Amgen Inc. | Self-buffering protein formulations |
| SG10201601621PA (en) | 2011-06-28 | 2016-04-28 | Inhibrx Llc | Serpin fusion polypeptides and methods of use thereof |
| CA2840711C (en) | 2011-07-01 | 2023-10-17 | Biogen Idec Ma Inc. | Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use |
| US10493151B2 (en) | 2011-10-18 | 2019-12-03 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with sodium chloride |
| IN2014CN02527A (enExample) * | 2011-10-18 | 2015-06-26 | Coherus Biosciences Inc | |
| HK1209343A1 (en) * | 2012-07-09 | 2016-04-01 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
| LT2892550T (lt) | 2012-09-07 | 2020-04-10 | Coherus Biosciences, Inc. | Stabilios adalimumabo vandeninės kompozicijos |
| CA2882551A1 (en) | 2012-09-11 | 2014-03-20 | Coherus Biosciences, Inc. | Correctly folded etanercept in high purity and excellent yield |
| JP6026002B2 (ja) * | 2012-11-27 | 2016-11-16 | アルテオジェン インコーポレイテッド | タンパク質とＦｃドメインを融合した融合タンパク質の安定化用組成物 |
| MX2015015051A (es) * | 2013-05-02 | 2016-06-10 | Mabxience S A | Formulaciones alternativas para polipeptidos de fusion tnfr:fc. |
| WO2015056613A1 (ja) * | 2013-10-15 | 2015-04-23 | Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 | 安定化されたポリペプチド水性製剤 |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP2946767B1 (en) | 2014-05-23 | 2016-10-05 | Ares Trading S.A. | Liquid pharmaceutical composition |
| LT2946765T (lt) | 2014-05-23 | 2016-11-25 | Ares Trading S.A. | Skysta farmacinė kompozicija |
| US9821059B2 (en) | 2014-10-17 | 2017-11-21 | Alteogen Inc. | Composition for stabilizing protein and pharmaceutical formulation comprising the same |
| BR112017013269A2 (pt) | 2014-12-22 | 2018-02-27 | Ares Trading S.A. | ?composição farmacêutica líquida? |
| KR20240132521A (ko) * | 2015-03-13 | 2024-09-03 | 삼성바이오에피스 주식회사 | 항-tnf-알파 폴리펩티드 조성물 및 그 용도 |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
| WO2018075818A1 (en) | 2016-10-21 | 2018-04-26 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| KR20180046888A (ko) * | 2016-10-28 | 2018-05-09 | (주)셀트리온 | 안정한 약제학적 제제 |
| CA3042126A1 (en) | 2018-05-03 | 2019-11-03 | Michael A. Portman | Methods of treating kawasaki disease |
| CN111228225B (zh) * | 2018-11-28 | 2022-08-26 | 鲁南制药集团股份有限公司 | 一种重组人肿瘤坏死因子受体-Fc融合蛋白冻干制剂 |
| GB201901547D0 (en) * | 2019-02-05 | 2019-03-27 | Arecor Ltd | Stabilized Fc Fusion protein solutions |
| CN118510549A (zh) * | 2021-09-22 | 2024-08-16 | 圣诺制药公司 | 具有减小的纳米颗粒尺寸和改善的多分散性指数的纳米颗粒药物组合物 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US5447851B1 (en) | 1992-04-02 | 1999-07-06 | Univ Texas System Board Of | Dna encoding a chimeric polypeptide comprising the extracellular domain of tnf receptor fused to igg vectors and host cells |
| US20010021380A1 (en) | 1999-04-19 | 2001-09-13 | Pluenneke John D. | Soluble tumor necrosis factor receptor treatment of medical disorders |
| US20040220103A1 (en) * | 1999-04-19 | 2004-11-04 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| EP1171148A2 (en) | 1999-04-19 | 2002-01-16 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical desorders |
| US6818613B2 (en) | 2001-11-07 | 2004-11-16 | Ortho-Mcneil Pharmaceutical, Inc. | Aqueous sustained-release formulations of proteins |
| MXPA04007924A (es) * | 2002-02-14 | 2005-05-17 | Chugai Pharmaceutical Co Ltd | Formulaciones en solucion que contienen anticuerpo. |
| WO2003072060A2 (en) | 2002-02-27 | 2003-09-04 | Immunex Corporation | Polypeptide formulation |
| EP1946776B1 (en) * | 2002-02-27 | 2017-01-18 | Immunex Corporation | Stabilized tnfr-fc composition comprising arginine |
| KR100471843B1 (ko) | 2002-06-11 | 2005-03-08 | 현대자동차주식회사 | 자동차의 아웃사이드 웨더스트립 장착구조 |
| SI3417875T1 (sl) | 2003-02-10 | 2021-01-29 | Biogen Ma Inc. | Formulacija imunoglobulina in metode za njegovo pripravo |
| EP1603596B1 (en) * | 2003-02-28 | 2008-05-07 | Ares Trading S.A. | Liquid formulations of tumor necrosis factor-binding protein tbp-1 |
| EP1654281A1 (en) * | 2003-08-01 | 2006-05-10 | Amgen, Inc. | Crystalline tumor necrosis factor receptor 2 polypeptides |
| TW200621282A (en) | 2004-08-13 | 2006-07-01 | Wyeth Corp | Stabilizing formulations |
| EP3673919A1 (en) * | 2005-06-14 | 2020-07-01 | Amgen Inc. | Self-buffering protein formulations |
| US20110046059A1 (en) * | 2005-09-06 | 2011-02-24 | Zelos Therapeutics, Inc. | Pharmaceutically acceptable formulations/compositions for peptidyl drugs |
| AU2007240732B2 (en) * | 2006-04-21 | 2013-07-04 | Amgen, Inc. | Buffering agents for biopharmaceutical formulations |
| ES2925992T3 (es) | 2006-10-20 | 2022-10-20 | Amgen Inc | Formulaciones estables de polipéptidos |
| WO2008127975A2 (en) * | 2007-04-11 | 2008-10-23 | Alcon Research, Ltd. | Use of an inhibitor of tnfa plus an antihistamine to treat allergic rhinitis and allergic conjunctivitis |
| NZ585702A (en) * | 2007-11-30 | 2013-08-30 | Abbott Lab | Protein formulations and methods of making same |
| US20130209465A1 (en) * | 2010-07-30 | 2013-08-15 | Arecor Ltd. | Stabilized Aqueous Antibody Compositions |
| CA2840711C (en) | 2011-07-01 | 2023-10-17 | Biogen Idec Ma Inc. | Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use |
-
2012
- 2012-06-29 CA CA2840711A patent/CA2840711C/en active Active
- 2012-06-29 KR KR1020147001595A patent/KR102061355B1/ko active Active
- 2012-06-29 BR BR112013033671-4A patent/BR112013033671B1/pt active IP Right Grant
- 2012-06-29 WO PCT/US2012/044988 patent/WO2013006454A1/en not_active Ceased
- 2012-06-29 JP JP2014519158A patent/JP6463968B2/ja active Active
- 2012-06-29 EA EA201490195A patent/EA026226B1/ru unknown
- 2012-06-29 AU AU2012279205A patent/AU2012279205B2/en active Active
- 2012-06-29 MX MX2018009524A patent/MX421100B/es unknown
- 2012-06-29 CN CN201280032584.XA patent/CN103930124B/zh active Active
- 2012-06-29 US US14/128,846 patent/US10995130B2/en active Active
- 2012-06-29 EP EP12738670.4A patent/EP2726090B1/en active Active
- 2012-06-29 CN CN202110408576.1A patent/CN113244374A/zh active Pending
- 2012-06-29 MX MX2014000093A patent/MX358137B/es active IP Right Grant
- 2012-06-29 DK DK12738670.4T patent/DK2726090T3/da active
-
2014
- 2014-01-21 ZA ZA2014/00490A patent/ZA201400490B/en unknown
-
2017
- 2017-05-18 JP JP2017098806A patent/JP2017186349A/ja active Pending
- 2017-11-21 AU AU2017265026A patent/AU2017265026B2/en active Active
-
2021
- 2021-03-30 US US17/216,769 patent/US11834491B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| MX421100B (es) | 2025-02-10 |
| US10995130B2 (en) | 2021-05-04 |
| KR20140056218A (ko) | 2014-05-09 |
| CA2840711A1 (en) | 2013-01-10 |
| AU2017265026B2 (en) | 2019-10-24 |
| JP2014518276A (ja) | 2014-07-28 |
| CA2840711C (en) | 2023-10-17 |
| US11834491B2 (en) | 2023-12-05 |
| BR112013033671A2 (pt) | 2017-01-24 |
| CN103930124B (zh) | 2021-05-11 |
| MX2018009524A (es) | 2021-11-16 |
| EP2726090A1 (en) | 2014-05-07 |
| DK2726090T3 (da) | 2020-01-20 |
| US20210309719A1 (en) | 2021-10-07 |
| ZA201400490B (en) | 2017-09-27 |
| EP2726090B1 (en) | 2020-01-01 |
| EA201490195A1 (ru) | 2014-04-30 |
| WO2013006454A1 (en) | 2013-01-10 |
| NZ620160A (en) | 2016-07-29 |
| KR102061355B1 (ko) | 2019-12-31 |
| JP2017186349A (ja) | 2017-10-12 |
| AU2012279205A1 (en) | 2014-02-06 |
| CN103930124A (zh) | 2014-07-16 |
| EA026226B1 (ru) | 2017-03-31 |
| US20140255400A1 (en) | 2014-09-11 |
| BR112013033671B1 (pt) | 2022-10-18 |
| AU2012279205B2 (en) | 2017-08-31 |
| MX2014000093A (es) | 2014-11-12 |
| CN113244374A (zh) | 2021-08-13 |
| AU2017265026A1 (en) | 2017-12-07 |
| MX358137B (es) | 2018-08-06 |
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