ECSP21043639A - Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf - Google Patents
Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegfInfo
- Publication number
- ECSP21043639A ECSP21043639A ECSENADI202143639A ECDI202143639A ECSP21043639A EC SP21043639 A ECSP21043639 A EC SP21043639A EC SENADI202143639 A ECSENADI202143639 A EC SENADI202143639A EC DI202143639 A ECDI202143639 A EC DI202143639A EC SP21043639 A ECSP21043639 A EC SP21043639A
- Authority
- EC
- Ecuador
- Prior art keywords
- high concentration
- antibody
- protein solution
- formulation containing
- vegf antibody
- Prior art date
Links
Classifications
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- 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
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Indicating Or Recording The Presence, Absence, Or Direction Of Movement (AREA)
- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
- Magnetic Resonance Imaging Apparatus (AREA)
Abstract
La presente divulgación proporciona anticuerpos anti-VEGF formulados como alta concentración, composiciones farmacéuticas acuosas, adecuadas para una inyección, con preferencia una inyección intravítrea. Las composiciones farmacéuticas acuosas son útiles para el suministro de una alta concentración del ingrediente activo del anticuerpo a un paciente sin altos niveles de agregación de anticuerpos y sin un alto nivel de material particulado sub-visible. Una composición acuosa de la divulgación comprende un anticuerpo que tiene una concentración de al menos 50 mg/ml. Una composición farmacéutica acuosa de la divulgación incluye un azúcar, un agente tamponador, y un surfactante.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862781003P | 2018-12-18 | 2018-12-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP21043639A true ECSP21043639A (es) | 2021-07-30 |
Family
ID=69165422
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ECSENADI202143639A ECSP21043639A (es) | 2018-12-18 | 2021-06-16 | Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf |
Country Status (24)
| Country | Link |
|---|---|
| US (2) | US11945859B2 (es) |
| EP (1) | EP3897714A1 (es) |
| JP (2) | JP7089121B2 (es) |
| KR (1) | KR20210106476A (es) |
| CN (1) | CN113194993A (es) |
| AR (1) | AR117707A1 (es) |
| AU (1) | AU2019407063B2 (es) |
| BR (1) | BR112021011290A2 (es) |
| CA (1) | CA3119241A1 (es) |
| CL (1) | CL2021001587A1 (es) |
| CO (1) | CO2021007830A2 (es) |
| CR (1) | CR20210318A (es) |
| EC (1) | ECSP21043639A (es) |
| IL (1) | IL283456A (es) |
| JO (1) | JOP20210152A1 (es) |
| MX (1) | MX2021007393A (es) |
| MY (1) | MY206282A (es) |
| NZ (1) | NZ775956A (es) |
| PE (1) | PE20211602A1 (es) |
| PH (1) | PH12021551307A1 (es) |
| SG (1) | SG11202104653XA (es) |
| TW (1) | TWI857996B (es) |
| WO (1) | WO2020128792A1 (es) |
| ZA (1) | ZA202102986B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI0914251B1 (pt) | 2008-06-25 | 2022-07-19 | Novartis Ag | Imunoligante recombinante, seu fragmento de ligação ao antígeno, uso dos mesmos, e composição |
| PL2307458T3 (pl) | 2008-06-25 | 2018-08-31 | Esbatech, An Alcon Biomedical Research Unit Llc | Humanizacja przeciwciał króliczych z zastosowaniem uniwersalnego zrębu przeciwciała |
| KR102050040B1 (ko) | 2008-06-25 | 2019-11-28 | 에스바테크 - 어 노바티스 컴파니 엘엘씨 | ＴＮＦα를 저해하는 안정한 가용성 항체 |
| TWI806150B (zh) | 2014-11-07 | 2023-06-21 | 瑞士商諾華公司 | 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物 |
| EP3886946A1 (en) | 2019-06-05 | 2021-10-06 | Regeneron Pharmaceuticals, Inc. | Devices and methods for precision dose delivery |
| USD1120314S1 (en) | 2022-11-30 | 2026-03-24 | Regeneron Pharmaceuticals, Inc. | Dose delivery device |
| CN117820474A (zh) * | 2023-04-25 | 2024-04-05 | 南京贝思奥生物科技有限公司 | 改善眼部血管新生相关疾病的药物及其应用 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| BRPI0914251B1 (pt) | 2008-06-25 | 2022-07-19 | Novartis Ag | Imunoligante recombinante, seu fragmento de ligação ao antígeno, uso dos mesmos, e composição |
| PL2307458T3 (pl) | 2008-06-25 | 2018-08-31 | Esbatech, An Alcon Biomedical Research Unit Llc | Humanizacja przeciwciał króliczych z zastosowaniem uniwersalnego zrębu przeciwciała |
| KR102050040B1 (ko) | 2008-06-25 | 2019-11-28 | 에스바테크 - 어 노바티스 컴파니 엘엘씨 | ＴＮＦα를 저해하는 안정한 가용성 항체 |
| WO2012076670A2 (en) | 2010-12-10 | 2012-06-14 | Novartis Ag | Antibody formulation |
| US20140213759A1 (en) | 2011-06-16 | 2014-07-31 | Lonza Braine S.A. | Process For Extraction Of Peptides And Its Application In Liquid Phase Peptide Synthesis |
| AR086823A1 (es) | 2011-06-30 | 2014-01-22 | Genentech Inc | Formulaciones de anticuerpo anti-c-met, metodos |
| US20140004131A1 (en) | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
| US9216219B2 (en) * | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| DE202013000688U1 (de) | 2012-07-03 | 2013-03-05 | Novartis Ag | Glas-Spritze |
| US9388239B2 (en) | 2014-05-01 | 2016-07-12 | Consejo Nacional De Investigation Cientifica | Anti-human VEGF antibodies with unusually strong binding affinity to human VEGF-A and cross reactivity to human VEGF-B |
| TWI806150B (zh) * | 2014-11-07 | 2023-06-21 | 瑞士商諾華公司 | 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物 |
| US20160144025A1 (en) | 2014-11-25 | 2016-05-26 | Regeneron Pharmaceuticals, Inc. | Methods and formulations for treating vascular eye diseases |
| KR20200131839A (ko) | 2018-03-16 | 2020-11-24 | 노파르티스 아게 | 안질환의 치료 방법 |
-
2019
- 2019-12-16 PE PE2021000916A patent/PE20211602A1/es unknown
- 2019-12-16 NZ NZ775956A patent/NZ775956A/en unknown
- 2019-12-16 CN CN201980081759.8A patent/CN113194993A/zh active Pending
- 2019-12-16 PH PH1/2021/551307A patent/PH12021551307A1/en unknown
- 2019-12-16 CA CA3119241A patent/CA3119241A1/en active Pending
- 2019-12-16 AR ARP190103687A patent/AR117707A1/es unknown
- 2019-12-16 TW TW108146070A patent/TWI857996B/zh active
- 2019-12-16 US US16/715,580 patent/US11945859B2/en active Active
- 2019-12-16 BR BR112021011290A patent/BR112021011290A2/pt unknown
- 2019-12-16 MX MX2021007393A patent/MX2021007393A/es unknown
- 2019-12-16 AU AU2019407063A patent/AU2019407063B2/en active Active
- 2019-12-16 WO PCT/IB2019/060859 patent/WO2020128792A1/en not_active Ceased
- 2019-12-16 EP EP19836538.9A patent/EP3897714A1/en active Pending
- 2019-12-16 MY MYPI2021002599A patent/MY206282A/en unknown
- 2019-12-16 CR CR20210318A patent/CR20210318A/es unknown
- 2019-12-16 JP JP2021534608A patent/JP7089121B2/ja active Active
- 2019-12-16 KR KR1020217021741A patent/KR20210106476A/ko active Pending
- 2019-12-16 SG SG11202104653XA patent/SG11202104653XA/en unknown
-
2021
- 2021-05-04 ZA ZA2021/02986A patent/ZA202102986B/en unknown
- 2021-05-25 IL IL283456A patent/IL283456A/en unknown
- 2021-06-15 JO JOP/2021/0152A patent/JOP20210152A1/ar unknown
- 2021-06-15 CO CONC2021/0007830A patent/CO2021007830A2/es unknown
- 2021-06-16 EC ECSENADI202143639A patent/ECSP21043639A/es unknown
- 2021-06-16 CL CL2021001587A patent/CL2021001587A1/es unknown
-
2022
- 2022-04-20 JP JP2022069588A patent/JP2022105056A/ja active Pending
-
2024
- 2024-02-16 US US18/444,288 patent/US20240182554A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| TWI857996B (zh) | 2024-10-11 |
| WO2020128792A1 (en) | 2020-06-25 |
| BR112021011290A2 (pt) | 2021-11-03 |
| JOP20210152A1 (ar) | 2021-06-15 |
| AU2019407063A1 (en) | 2021-05-27 |
| AR117707A1 (es) | 2021-08-25 |
| CR20210318A (es) | 2021-07-14 |
| PH12021551307A1 (en) | 2022-05-16 |
| SG11202104653XA (en) | 2021-07-29 |
| US20200190179A1 (en) | 2020-06-18 |
| MY206282A (en) | 2024-12-06 |
| ZA202102986B (en) | 2024-08-28 |
| EP3897714A1 (en) | 2021-10-27 |
| AU2019407063B2 (en) | 2024-07-04 |
| JP2022513253A (ja) | 2022-02-07 |
| IL283456A (en) | 2021-07-29 |
| MX2021007393A (es) | 2021-09-23 |
| KR20210106476A (ko) | 2021-08-30 |
| PE20211602A1 (es) | 2021-08-18 |
| US11945859B2 (en) | 2024-04-02 |
| CN113194993A (zh) | 2021-07-30 |
| NZ775956A (en) | 2024-12-20 |
| CO2021007830A2 (es) | 2021-06-21 |
| JP2022105056A (ja) | 2022-07-12 |
| JP7089121B2 (ja) | 2022-06-21 |
| CA3119241A1 (en) | 2020-06-25 |
| US20240182554A1 (en) | 2024-06-06 |
| CL2021001587A1 (es) | 2022-02-11 |
| TW202031289A (zh) | 2020-09-01 |
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