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
- 108010008165 Etanercept Proteins 0.000 title abstract 5
- 229960000403 etanercept Drugs 0.000 title abstract 5
- 238000000034 method Methods 0.000 abstract 5
- 238000002360 preparation method Methods 0.000 abstract 3
- 108090000623 proteins and genes Proteins 0.000 abstract 3
- 102000004169 proteins and genes Human genes 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 1
- 238000012434 mixed-mode chromatography Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- 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
-
- 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)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (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)
- Mycology (AREA)
- Microbiology (AREA)
- Pain & Pain Management (AREA)
- Dermatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (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) | KR102250937B1 (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) | TWI609877B (es) |
| WO (1) | WO2014043103A1 (es) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2776657T3 (es) | 2005-06-14 | 2020-07-31 | Amgen Inc | Formulaciones de proteínas autotamponantes |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| EA026410B1 (ru) | 2011-10-18 | 2017-04-28 | Кохерус Байосайенсис, Инк. | Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов |
| WO2014043103A1 (en) * | 2012-09-11 | 2014-03-20 | Coherus Biosciences, Inc. | Correctly folded etanercept in high purity and excellent yield |
| WO2015189832A1 (en) * | 2014-06-13 | 2015-12-17 | Lupin Limited | Process for the purification of tnfr:fc fusion protein |
| EP2975050B1 (en) * | 2014-07-18 | 2019-05-29 | Sandoz Ag | Quantification of misfolded TNFR2:Fc |
| MX394035B (es) * | 2014-12-31 | 2025-03-21 | Lg Chemical Ltd | Procedimiento para preparar una proteina de fusion tnfr-fc que contiene un contenido objetivo de impurezas. |
| KR20240132521A (ko) | 2015-03-13 | 2024-09-03 | 삼성바이오에피스 주식회사 | 항-tnf-알파 폴리펩티드 조성물 및 그 용도 |
| WO2017084737A1 (en) * | 2015-11-18 | 2017-05-26 | Merck Patent Gmbh | Improved protein separation in ion exchange chromatography |
| MX2018005831A (es) * | 2015-11-18 | 2018-08-01 | Merck Patent Gmbh | Gradientes de ph-sal opuestos para separaciones de proteina mejoradas. |
| HRP20241323T1 (hr) * | 2016-06-17 | 2024-12-20 | F. Hoffmann - La Roche Ag | Pročišćavanje multispecifičnih protutijela |
| CA3040899A1 (en) * | 2016-10-21 | 2018-04-26 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| EP3824906A1 (en) | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| EP3601332A1 (en) * | 2017-03-24 | 2020-02-05 | 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 |
| CA3235508A1 (en) * | 2021-10-19 | 2023-05-11 | Soon Jae Park | Method for purifying fusion protein having igg fc domain |
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-
2013
- 2013-09-10 WO PCT/US2013/058994 patent/WO2014043103A1/en not_active Ceased
- 2013-09-10 ES ES13838016.7T patent/ES2657377T3/es active Active
- 2013-09-10 CA CA2882551A patent/CA2882551A1/en active Pending
- 2013-09-10 PE PE2015000316A patent/PE20150996A1/es unknown
- 2013-09-10 LT LTEP13838016.7T patent/LT2895188T/lt unknown
- 2013-09-10 DK DK13838016.7T patent/DK2895188T3/en active
- 2013-09-10 EA EA201590542A patent/EA031324B1/ru unknown
- 2013-09-10 HU HUE13838016A patent/HUE036524T2/hu unknown
- 2013-09-10 PL PL13838016T patent/PL2895188T3/pl unknown
- 2013-09-10 MX MX2015003090A patent/MX360044B/es active IP Right Grant
- 2013-09-10 RS RS20180095A patent/RS57013B1/sr unknown
- 2013-09-10 CN CN201811633164.2A patent/CN110051823A/zh active Pending
- 2013-09-10 IN IN452KON2015 patent/IN2015KN00452A/en unknown
- 2013-09-10 PT PT138380167T patent/PT2895188T/pt unknown
- 2013-09-10 SI SI201330936T patent/SI2895188T1/en unknown
- 2013-09-10 KR KR1020207019733A patent/KR102250937B1/ko not_active Expired - Fee Related
- 2013-09-10 SG SG11201501460RA patent/SG11201501460RA/en unknown
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