CA2840711C - Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use - Google Patents
Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use Download PDFInfo
- Publication number
- CA2840711C CA2840711C CA2840711A CA2840711A CA2840711C CA 2840711 C CA2840711 C CA 2840711C CA 2840711 A CA2840711 A CA 2840711A CA 2840711 A CA2840711 A CA 2840711A CA 2840711 C CA2840711 C CA 2840711C
- Authority
- CA
- Canada
- Prior art keywords
- composition
- composition according
- concentration
- polypeptide
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- 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
- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
-
- 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 [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
- C07K16/241—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)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2840711A1 CA2840711A1 (en) | 2013-01-10 |
| CA2840711C true CA2840711C (en) | 2023-10-17 |
Family
ID=46579322
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2840711A Active CA2840711C (en) | 2011-07-01 | 2012-06-29 | Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10995130B2 (https=) |
| EP (1) | EP2726090B1 (https=) |
| JP (2) | JP6463968B2 (https=) |
| KR (1) | KR102061355B1 (https=) |
| CN (2) | CN103930124B (https=) |
| AU (2) | AU2012279205B2 (https=) |
| BR (1) | BR112013033671B1 (https=) |
| CA (1) | CA2840711C (https=) |
| DK (1) | DK2726090T3 (https=) |
| EA (1) | EA026226B1 (https=) |
| MX (2) | MX358137B (https=) |
| WO (1) | WO2013006454A1 (https=) |
| ZA (1) | ZA201400490B (https=) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0611901A2 (pt) | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| KR102231139B1 (ko) | 2011-06-28 | 2021-03-24 | 인히브릭스, 인크. | 세르핀 융합 폴리펩타이드 및 이의 이용 방법 |
| CN103930124B (zh) | 2011-07-01 | 2021-05-11 | 生物基因Ma公司 | 无精氨酸的tnfr：fc-融合多肽组合物及使用方法 |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| BR112014009146A8 (pt) * | 2011-10-18 | 2017-06-20 | Coherus Biosciences Inc | formulações de etanercepte estabilizadas com aminoácidos |
| HK1209343A1 (en) | 2012-07-09 | 2016-04-01 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
| PE20150964A1 (es) | 2012-09-07 | 2015-07-25 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| SI2895188T1 (en) | 2012-09-11 | 2018-05-31 | Coherus Biosciences, Inc. | CORRECTED QUALITY ETHANERCEPT WITH HIGH QUALITY AND EXCELLENT EXPERIENCE |
| CN104870019A (zh) * | 2012-11-27 | 2015-08-26 | 阿特根公司 | 用于稳定蛋白质和Fc结构域融合的融合蛋白的组合物 |
| CN105873601A (zh) * | 2013-05-02 | 2016-08-17 | 马柏克辛斯公司 | TNFR:Fc融合多肽的替代配方 |
| 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 |
| ES2572919T3 (es) | 2014-05-23 | 2016-06-03 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946767B1 (en) | 2014-05-23 | 2016-10-05 | Ares Trading S.A. | Liquid pharmaceutical composition |
| PT2946765T (pt) | 2014-05-23 | 2016-11-10 | Ares Trading Sa | Composição farmacêutica líquida |
| US9821059B2 (en) * | 2014-10-17 | 2017-11-21 | Alteogen Inc. | Composition for stabilizing protein and pharmaceutical formulation comprising the same |
| CA2970577A1 (en) * | 2014-12-22 | 2016-06-30 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3268042B1 (en) * | 2015-03-13 | 2024-11-27 | Samsung Bioepis Co., Ltd. | Anti-tnf-alpha polypeptide composition and use thereof |
| 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 |
| PT3528787T (pt) | 2016-10-21 | 2026-03-11 | Amgen Inc | Formulações farmacêuticas e métodos para produzir as mesmas |
| WO2018080196A2 (ko) * | 2016-10-28 | 2018-05-03 | (주)셀트리온 | 안정한 약제학적 제제 |
| US11253569B2 (en) | 2018-05-03 | 2022-02-22 | Seattle Children's Hospital | 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 |
| WO2023049814A2 (en) * | 2021-09-22 | 2023-03-30 | Sirnaomics, Inc. | Nanoparticle pharmaceutical compositions with reduced nanoparticle size and improved polydispersity index |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US20040220103A1 (en) | 1999-04-19 | 2004-11-04 | Immunex Corporation | Soluble tumor necrosis factor receptor treatment of medical disorders |
| US20010021380A1 (en) | 1999-04-19 | 2001-09-13 | Pluenneke John D. | 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 |
| CN101721362B (zh) * | 2002-02-14 | 2018-07-03 | 中外制药株式会社 | 包含抗体的溶液制剂 |
| EP3210624A1 (en) * | 2002-02-27 | 2017-08-30 | Immunex Corporation | Stabilized tnfr-fc composition comprising arginine |
| SI1478394T1 (sl) | 2002-02-27 | 2008-12-31 | Immunex Corp | STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM |
| KR100471843B1 (ko) | 2002-06-11 | 2005-03-08 | 현대자동차주식회사 | 자동차의 아웃사이드 웨더스트립 장착구조 |
| DK2236154T3 (en) | 2003-02-10 | 2018-06-25 | Biogen Ma Inc | IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT |
| JP4980048B2 (ja) * | 2003-02-28 | 2012-07-18 | アレス トレーディング ソシエテ アノニム | 腫瘍壊死因子結合タンパク質の液体製剤 |
| BRPI0413197A (pt) * | 2003-08-01 | 2006-10-03 | Amgen Inc | cristal de eta wercept; método para fabricar um cristal de etanercept; composição; uso de um cristal de etanercept |
| TW200621282A (en) | 2004-08-13 | 2006-07-01 | Wyeth Corp | Stabilizing formulations |
| BRPI0611901A2 (pt) | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| 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 |
| EP2094247B1 (en) | 2006-10-20 | 2022-06-29 | Amgen Inc. | Stable polypeptide formulations |
| KR20100014565A (ko) * | 2007-04-11 | 2010-02-10 | 알콘 리서치, 리미티드 | 알레르기성 비염 및 알레르기성 결막염을 치료하기 위한 ｔｎｆａ의 억제제 및 항히스타민의 용도 |
| US8420081B2 (en) | 2007-11-30 | 2013-04-16 | Abbvie, Inc. | Antibody formulations and methods of making same |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| CN103930124B (zh) | 2011-07-01 | 2021-05-11 | 生物基因Ma公司 | 无精氨酸的tnfr：fc-融合多肽组合物及使用方法 |
-
2012
- 2012-06-29 CN CN201280032584.XA patent/CN103930124B/zh 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 AU AU2012279205A patent/AU2012279205B2/en active Active
- 2012-06-29 MX MX2018009524A patent/MX421100B/es unknown
- 2012-06-29 CA CA2840711A patent/CA2840711C/en active Active
- 2012-06-29 BR BR112013033671-4A patent/BR112013033671B1/pt active IP Right Grant
- 2012-06-29 EP EP12738670.4A patent/EP2726090B1/en active Active
- 2012-06-29 EA EA201490195A patent/EA026226B1/ru unknown
- 2012-06-29 WO PCT/US2012/044988 patent/WO2013006454A1/en not_active Ceased
- 2012-06-29 DK DK12738670.4T patent/DK2726090T3/da active
- 2012-06-29 US US14/128,846 patent/US10995130B2/en active Active
- 2012-06-29 KR KR1020147001595A patent/KR102061355B1/ko active Active
- 2012-06-29 JP JP2014519158A patent/JP6463968B2/ja active 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 |
|---|---|
| US11834491B2 (en) | 2023-12-05 |
| AU2012279205B2 (en) | 2017-08-31 |
| MX2014000093A (es) | 2014-11-12 |
| JP2017186349A (ja) | 2017-10-12 |
| MX2018009524A (es) | 2021-11-16 |
| EA026226B1 (ru) | 2017-03-31 |
| WO2013006454A1 (en) | 2013-01-10 |
| AU2012279205A1 (en) | 2014-02-06 |
| US20210309719A1 (en) | 2021-10-07 |
| DK2726090T3 (da) | 2020-01-20 |
| CN113244374A (zh) | 2021-08-13 |
| AU2017265026A1 (en) | 2017-12-07 |
| US20140255400A1 (en) | 2014-09-11 |
| CN103930124B (zh) | 2021-05-11 |
| BR112013033671A2 (pt) | 2017-01-24 |
| ZA201400490B (en) | 2017-09-27 |
| EA201490195A1 (ru) | 2014-04-30 |
| CA2840711A1 (en) | 2013-01-10 |
| JP2014518276A (ja) | 2014-07-28 |
| US10995130B2 (en) | 2021-05-04 |
| JP6463968B2 (ja) | 2019-02-06 |
| MX421100B (es) | 2025-02-10 |
| AU2017265026B2 (en) | 2019-10-24 |
| CN103930124A (zh) | 2014-07-16 |
| MX358137B (es) | 2018-08-06 |
| EP2726090A1 (en) | 2014-05-07 |
| NZ620160A (en) | 2016-07-29 |
| EP2726090B1 (en) | 2020-01-01 |
| KR20140056218A (ko) | 2014-05-09 |
| KR102061355B1 (ko) | 2019-12-31 |
| BR112013033671B1 (pt) | 2022-10-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20170622 |
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| MPN | Maintenance fee for patent paid |
Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 13TH ANNIV.) - STANDARD Year of fee payment: 13 |
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| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20250527 |
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| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20250527 |