DOP2015000055A - Etanercept correctamente plegado de alta pureza y excelente rendimiento - Google Patents
Etanercept correctamente plegado de alta pureza y excelente rendimientoInfo
- Publication number
- DOP2015000055A DOP2015000055A DO2015000055A DO2015000055A DOP2015000055A DO P2015000055 A DOP2015000055 A DO P2015000055A DO 2015000055 A DO2015000055 A DO 2015000055A DO 2015000055 A DO2015000055 A DO 2015000055A DO P2015000055 A DOP2015000055 A DO P2015000055A
- Authority
- DO
- Dominican Republic
- Prior art keywords
- etanercept
- correctly folded
- high purity
- folded
- preparations
- 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)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Cell Biology (AREA)
- Toxicology (AREA)
- Zoology (AREA)
- Analytical Chemistry (AREA)
- Rheumatology (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Dermatology (AREA)
- Pain & Pain Management (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 |
|---|---|
| DOP2015000055A true DOP2015000055A (es) | 2015-04-30 |
Family
ID=50233493
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DO2015000055A DOP2015000055A (es) | 2012-09-11 | 2015-03-10 | 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) | KR102250937B1 (es) |
| CN (2) | CN104902914B (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) | PE20200607A1 (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) | TWI609877B (es) |
| WO (1) | WO2014043103A1 (es) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2007015476A (es) | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| HK1200718A1 (en) | 2011-10-18 | 2015-08-14 | 科荣生生物科学公司 | Etanercept formulations stabilized with sodium chloride |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| EA031324B1 (ru) * | 2012-09-11 | 2018-12-28 | Кохерус Байосайенсис, Инк. | Правильно свернутый этанерцепт с высокой чистотой и высоким уровнем выхода |
| AU2015273049B2 (en) * | 2014-06-13 | 2019-11-14 | Lupin Limited | Process for the purification of TNFR:Fc fusion protein |
| 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 |
| KR20170138426A (ko) | 2015-03-13 | 2017-12-15 | 삼성바이오에피스 주식회사 | 항-tnf-알파 폴리펩티드 조성물 및 그 용도 |
| SG11201804083QA (en) * | 2015-11-18 | 2018-06-28 | Merck Patent Gmbh | Opposite ph-salt gradients for improved protein separations |
| US20180327447A1 (en) * | 2015-11-18 | 2018-11-15 | Merck Patent Gmbh | Improved protein separation in ion exchange chromatography |
| CN109563124A (zh) * | 2016-06-17 | 2019-04-02 | 豪夫迈·罗氏有限公司 | 多特异性抗体的纯化 |
| AU2017345490B2 (en) * | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| CA3057286A1 (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 |
| EP4142792A4 (en) | 2020-05-01 | 2024-11-27 | Kashiv Biosciences, LLC | An improved process of purification of protein |
| US20240156907A1 (en) * | 2021-03-16 | 2024-05-16 | 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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-
2013
- 2013-09-10 EA EA201590542A patent/EA031324B1/ru unknown
- 2013-09-10 HR HRP20180182TT patent/HRP20180182T1/hr unknown
- 2013-09-10 BR BR112015005161A patent/BR112015005161A2/pt not_active Application Discontinuation
- 2013-09-10 CN CN201380058650.5A patent/CN104902914B/zh not_active Expired - Fee Related
- 2013-09-10 ES ES13838016.7T patent/ES2657377T3/es active Active
- 2013-09-10 SM SM20180163T patent/SMT201800163T1/it unknown
- 2013-09-10 SI SI201330936T patent/SI2895188T1/en unknown
- 2013-09-10 PE PE2019002512A patent/PE20200607A1/es unknown
- 2013-09-10 EP EP13838016.7A patent/EP2895188B1/en active Active
- 2013-09-10 CN CN201811633164.2A patent/CN110051823A/zh active Pending
- 2013-09-10 LT LTEP13838016.7T patent/LT2895188T/lt unknown
- 2013-09-10 HU HUE13838016A patent/HUE036524T2/hu unknown
- 2013-09-10 AU AU2013315750A patent/AU2013315750B9/en not_active Ceased
- 2013-09-10 DK DK13838016.7T patent/DK2895188T3/en active
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