ECSP15014138A - Etanercept correctamente plegado de alta pureza y excelente rendimiento - Google Patents
Etanercept correctamente plegado de alta pureza y excelente rendimientoInfo
- Publication number
- ECSP15014138A ECSP15014138A ECIEPI201514138A ECPI201514138A ECSP15014138A EC SP15014138 A ECSP15014138 A EC SP15014138A EC IEPI201514138 A ECIEPI201514138 A EC IEPI201514138A EC PI201514138 A ECPI201514138 A EC PI201514138A EC SP15014138 A ECSP15014138 A EC SP15014138A
- Authority
- EC
- Ecuador
- Prior art keywords
- high purity
- etanercept
- folded
- preparations
- folded etanercept
- Prior art date
Links
Classifications
-
- 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
-
- 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)
Abstract
Método de cromatografía de modo mixto para separar las conformaciones correctamente plegadas de las incorrectamente plegadas de una proteína dada. El método es muy eficaz en la separación de etanercept correctamente plegado del etanercept incorrectamente plegado y de agregados con rendimientos comercialmente atractivos que permiten obtener preparaciones de etanercept de una muy alta pureza en términos de etanercept correctamente plegado versus etanercept incorrectamente plegado. La invención está dirigida además a preparaciones de proteínas y formulaciones que comprenden proteínas correctamente plegadas obtenidas usando los métodos de la presente, y métodos de tratamiento que emplean las preparaciones de gran pureza obtenidas del método de modo mixto.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261699552P | 2012-09-11 | 2012-09-11 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP15014138A true ECSP15014138A (es) | 2016-01-29 |
Family
ID=50233493
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECIEPI201514138A ECSP15014138A (es) | 2012-09-11 | 2015-04-10 | Etanercept correctamente plegado de alta pureza y excelente rendimiento |
Country Status (33)
| Country | Link |
|---|---|
| US (6) | US20140072560A1 (es) |
| EP (1) | EP2895188B1 (es) |
| JP (3) | JP2015533797A (es) |
| KR (2) | KR102133699B1 (es) |
| CN (2) | CN110051823A (es) |
| AR (1) | AR092532A1 (es) |
| AU (2) | AU2013315750B9 (es) |
| BR (1) | BR112015005161A2 (es) |
| CA (1) | CA2882551A1 (es) |
| CL (1) | CL2015000572A1 (es) |
| CO (1) | CO7400876A2 (es) |
| CY (1) | CY1120062T1 (es) |
| DK (1) | DK2895188T3 (es) |
| DO (1) | DOP2015000055A (es) |
| EA (1) | EA031324B1 (es) |
| EC (1) | ECSP15014138A (es) |
| ES (1) | ES2657377T3 (es) |
| HR (1) | HRP20180182T1 (es) |
| HU (1) | HUE036524T2 (es) |
| IL (2) | IL237311B (es) |
| IN (1) | IN2015KN00452A (es) |
| LT (1) | LT2895188T (es) |
| MX (2) | MX360044B (es) |
| NO (1) | NO2972131T3 (es) |
| PE (2) | PE20150996A1 (es) |
| PL (1) | PL2895188T3 (es) |
| PT (1) | PT2895188T (es) |
| RS (1) | RS57013B1 (es) |
| SG (1) | SG11201501460RA (es) |
| SI (1) | SI2895188T1 (es) |
| SM (1) | SMT201800163T1 (es) |
| TW (2) | TWI716649B (es) |
| WO (1) | WO2014043103A1 (es) |
Families Citing this family (21)
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|---|---|---|---|---|
| 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 |
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| 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 |
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| EP4696709A1 (en) * | 2024-12-06 | 2026-02-18 | Qilu Pharmaceutical Co., Ltd. | Variants of etanercept and related processes |
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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
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