TWI716649B - 高純度及優良產量之正確折疊之恩博(etanercept) - Google Patents
高純度及優良產量之正確折疊之恩博(etanercept) Download PDFInfo
- Publication number
- TWI716649B TWI716649B TW106136921A TW106136921A TWI716649B TW I716649 B TWI716649 B TW I716649B TW 106136921 A TW106136921 A TW 106136921A TW 106136921 A TW106136921 A TW 106136921A TW I716649 B TWI716649 B TW I716649B
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- Prior art keywords
- protein
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Classifications
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- 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
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Toxicology (AREA)
- Zoology (AREA)
- Cell Biology (AREA)
- Analytical Chemistry (AREA)
- Rheumatology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261699552P | 2012-09-11 | 2012-09-11 | |
| US61/699,552 | 2012-09-11 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| TW201803593A TW201803593A (zh) | 2018-02-01 |
| TWI716649B true TWI716649B (zh) | 2021-01-21 |
Family
ID=50233493
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW106136921A TWI716649B (zh) | 2012-09-11 | 2013-09-11 | 高純度及優良產量之正確折疊之恩博(etanercept) |
| TW102132831A TWI609877B (zh) | 2012-09-11 | 2013-09-11 | 高純度及優良產量之正確折疊之恩博(etanercept) |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW102132831A TWI609877B (zh) | 2012-09-11 | 2013-09-11 | 高純度及優良產量之正確折疊之恩博(etanercept) |
Country Status (33)
| Country | Link |
|---|---|
| US (6) | US20140072560A1 (https=) |
| EP (1) | EP2895188B1 (https=) |
| JP (3) | JP2015533797A (https=) |
| KR (2) | KR102133699B1 (https=) |
| CN (2) | CN110051823A (https=) |
| AR (1) | AR092532A1 (https=) |
| AU (2) | AU2013315750B9 (https=) |
| BR (1) | BR112015005161A2 (https=) |
| CA (1) | CA2882551A1 (https=) |
| CL (1) | CL2015000572A1 (https=) |
| CO (1) | CO7400876A2 (https=) |
| CY (1) | CY1120062T1 (https=) |
| DK (1) | DK2895188T3 (https=) |
| DO (1) | DOP2015000055A (https=) |
| EA (1) | EA031324B1 (https=) |
| EC (1) | ECSP15014138A (https=) |
| ES (1) | ES2657377T3 (https=) |
| HR (1) | HRP20180182T1 (https=) |
| HU (1) | HUE036524T2 (https=) |
| IL (2) | IL237311B (https=) |
| IN (1) | IN2015KN00452A (https=) |
| LT (1) | LT2895188T (https=) |
| MX (2) | MX360044B (https=) |
| NO (1) | NO2972131T3 (https=) |
| PE (2) | PE20150996A1 (https=) |
| PL (1) | PL2895188T3 (https=) |
| PT (1) | PT2895188T (https=) |
| RS (1) | RS57013B1 (https=) |
| SG (1) | SG11201501460RA (https=) |
| SI (1) | SI2895188T1 (https=) |
| SM (1) | SMT201800163T1 (https=) |
| TW (2) | TWI716649B (https=) |
| WO (1) | WO2014043103A1 (https=) |
Families Citing this family (21)
| 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 |
| BR112014009146A8 (pt) | 2011-10-18 | 2017-06-20 | Coherus Biosciences Inc | formulações de etanercepte estabilizadas com aminoácidos |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| SI2895188T1 (en) * | 2012-09-11 | 2018-05-31 | Coherus Biosciences, Inc. | CORRECTED QUALITY ETHANERCEPT WITH HIGH QUALITY AND EXCELLENT EXPERIENCE |
| MX2016016318A (es) * | 2014-06-13 | 2017-06-12 | Lupin Atlantis Holdings Sa | Proceso para la purificacion de la proteina de fusion. |
| ES2733298T3 (es) | 2014-07-18 | 2019-11-28 | Sandoz Ag | Cuantificación de TNFR2:Fc plegado erróneamente |
| EP3241849A4 (en) | 2014-12-31 | 2018-06-20 | LG Chem, Ltd. | Method for producing tnfr-fc fusion protein containing target content of impurities |
| EP3268042B1 (en) | 2015-03-13 | 2024-11-27 | Samsung Bioepis Co., Ltd. | Anti-tnf-alpha polypeptide composition and use thereof |
| JP2018537458A (ja) * | 2015-11-18 | 2018-12-20 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングMerck Patent Gesellschaft mit beschraenkter Haftung | 改善されたタンパク質分離のための逆pH塩勾配 |
| BR112018009881A2 (pt) * | 2015-11-18 | 2018-11-13 | Merck Patent Gmbh | separação de proteína aperfeiçoada em cromatografia de troca iônica |
| EP4549463A3 (en) * | 2016-06-17 | 2025-07-30 | F. Hoffmann-La Roche AG | Purification of multispecific antibodies |
| PT3528787T (pt) | 2016-10-21 | 2026-03-11 | Amgen Inc | Formulações farmacêuticas e métodos para produzir as mesmas |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| WO2018173075A1 (en) * | 2017-03-24 | 2018-09-27 | Council Of Scientific And Industrial Research | A process for the purification of recombinant antibody fragments |
| US11253569B2 (en) | 2018-05-03 | 2022-02-22 | Seattle Children's Hospital | Methods of treating Kawasaki Disease |
| CN112876567A (zh) * | 2019-11-29 | 2021-06-01 | 广东菲鹏制药股份有限公司 | Fc融合蛋白及其纯化方法 |
| AU2021262609A1 (en) | 2020-05-01 | 2022-12-22 | Kashiv Biosciences, Llc | An improved process of purification of protein |
| WO2022195505A1 (en) * | 2021-03-16 | 2022-09-22 | Kashiv Biosciences, Llc | Novel formulation of fusion protein |
| WO2022234412A1 (en) * | 2021-05-03 | 2022-11-10 | Lupin Limited | A process for purification of fc-fusion proteins |
| CN118414350A (zh) * | 2021-10-19 | 2024-07-30 | 阿特根公司 | 纯化具有igg fc结构域的融合蛋白的方法 |
| EP4696709A1 (en) * | 2024-12-06 | 2026-02-18 | Qilu Pharmaceutical Co., Ltd. | Variants of etanercept and related processes |
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| HK1209343A1 (en) * | 2012-07-09 | 2016-04-01 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
| SI2895188T1 (en) * | 2012-09-11 | 2018-05-31 | Coherus Biosciences, Inc. | CORRECTED QUALITY ETHANERCEPT WITH HIGH QUALITY AND EXCELLENT EXPERIENCE |
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-
2013
- 2013-09-10 SI SI201330936T patent/SI2895188T1/en unknown
- 2013-09-10 EA EA201590542A patent/EA031324B1/ru unknown
- 2013-09-10 SG SG11201501460RA patent/SG11201501460RA/en unknown
- 2013-09-10 PE PE2015000316A patent/PE20150996A1/es unknown
- 2013-09-10 KR KR1020157009386A patent/KR102133699B1/ko not_active Expired - Fee Related
- 2013-09-10 HU HUE13838016A patent/HUE036524T2/hu unknown
- 2013-09-10 DK DK13838016.7T patent/DK2895188T3/en active
- 2013-09-10 KR KR1020207019733A patent/KR102250937B1/ko not_active Expired - Fee Related
- 2013-09-10 SM SM20180163T patent/SMT201800163T1/it unknown
- 2013-09-10 BR BR112015005161A patent/BR112015005161A2/pt not_active Application Discontinuation
- 2013-09-10 PL PL13838016T patent/PL2895188T3/pl unknown
- 2013-09-10 WO PCT/US2013/058994 patent/WO2014043103A1/en not_active Ceased
- 2013-09-10 MX MX2015003090A patent/MX360044B/es active IP Right Grant
- 2013-09-10 AU AU2013315750A patent/AU2013315750B9/en not_active Ceased
- 2013-09-10 CN CN201811633164.2A patent/CN110051823A/zh active Pending
- 2013-09-10 PE PE2019002512A patent/PE20200607A1/es unknown
- 2013-09-10 PT PT138380167T patent/PT2895188T/pt unknown
- 2013-09-10 RS RS20180095A patent/RS57013B1/sr unknown
- 2013-09-10 JP JP2015531311A patent/JP2015533797A/ja active Pending
- 2013-09-10 CA CA2882551A patent/CA2882551A1/en active Pending
- 2013-09-10 LT LTEP13838016.7T patent/LT2895188T/lt unknown
- 2013-09-10 ES ES13838016.7T patent/ES2657377T3/es active Active
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