BR112017003419A2 - formulação de anticorpo anti-il-4r-alfa estável - Google Patents
formulação de anticorpo anti-il-4r-alfa estávelInfo
- Publication number
- BR112017003419A2 BR112017003419A2 BR112017003419A BR112017003419A BR112017003419A2 BR 112017003419 A2 BR112017003419 A2 BR 112017003419A2 BR 112017003419 A BR112017003419 A BR 112017003419A BR 112017003419 A BR112017003419 A BR 112017003419A BR 112017003419 A2 BR112017003419 A2 BR 112017003419A2
- Authority
- BR
- Brazil
- Prior art keywords
- formulation
- antibody
- relates
- stable
- antibody formulation
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 239000012537 formulation buffer Substances 0.000 abstract 2
- 101001002709 Homo sapiens Interleukin-4 Proteins 0.000 abstract 1
- 229910019142 PO4 Inorganic materials 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000012634 fragment Substances 0.000 abstract 1
- 102000055229 human IL4 Human genes 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 abstract 1
- 239000010452 phosphate Substances 0.000 abstract 1
- 239000004034 viscosity adjusting agent Substances 0.000 abstract 1
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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
-
- 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
-
- 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]
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/567—Framework region [FR]
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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Pulmonology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
a presente invenção refere-se a uma formulação de anticorpo estável e de baixa viscosidade, em que a formulação compreende uma elevada concentração de um anticorpo anti-il4r. em algumas modalidades, a invenção refere-se em geral a uma formulação de anticorpo estável compreendendo cerca de 100 mg/ml a cerca de 200 mg/ml de um anticorpo ou fragmento do mesmo que se liga especificamente ao receptor alfa de interleucina-4 humano (hil-4ra), cerca de 50 mm a cerca de 400 mm de um modificador de viscosidade, cerca de 0,002% a cerca de 0,2% de um tensoativo não iônico, e um tampão de formulação. em algumas modalidades, o tampão de formulação está essencialmente livre de fosfato. em algumas modalidades, a invenção diz respeito a um recipiente, uma forma de dosagem e/ou um kit. em algumas modalidades, a invenção diz respeito a um método de preparação e uso da formulação de anticorpo estável.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462045338P | 2014-09-03 | 2014-09-03 | |
| PCT/EP2015/070091 WO2016034648A1 (en) | 2014-09-03 | 2015-09-02 | Stable anti-il-4r-alpha antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112017003419A2 true BR112017003419A2 (pt) | 2017-11-28 |
Family
ID=54035254
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112017003419A BR112017003419A2 (pt) | 2014-09-03 | 2015-09-02 | formulação de anticorpo anti-il-4r-alfa estável |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20170281769A1 (pt) |
| EP (1) | EP3188757A1 (pt) |
| JP (1) | JP2017527560A (pt) |
| KR (1) | KR20170044739A (pt) |
| CN (1) | CN106604744A (pt) |
| AU (1) | AU2015310879A1 (pt) |
| BR (1) | BR112017003419A2 (pt) |
| CA (1) | CA2959571A1 (pt) |
| IL (1) | IL250363A0 (pt) |
| RU (1) | RU2017107847A (pt) |
| SG (1) | SG11201701458YA (pt) |
| WO (1) | WO2016034648A1 (pt) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RS64263B1 (sr) | 2015-08-19 | 2023-07-31 | Astrazeneca Ab | Stabilna anti-ifnar1 formulacija |
| JP2019511531A (ja) * | 2016-04-13 | 2019-04-25 | メディミューン，エルエルシー | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 |
| JOP20170170B1 (ar) * | 2016-08-31 | 2022-09-15 | Omeros Corp | صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق |
| US10646569B2 (en) | 2017-05-16 | 2020-05-12 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| CN110540590B (zh) * | 2018-05-29 | 2023-08-18 | 康诺亚生物医药科技（成都）有限公司 | 一种自免疫抑制物的开发和应用 |
| WO2020016417A1 (en) * | 2018-07-19 | 2020-01-23 | Ichnos Sciences S.A. | Liquid antibody formulation |
| BR112021002989A2 (pt) * | 2018-08-24 | 2021-05-11 | Jiangsu Hengrui Medicine Co., Ltd. | anticorpo para ligação de il-4r de humano, fragmento para ligação de antígeno e uso médico do mesmo |
| EP3878868B1 (en) | 2018-11-09 | 2024-10-09 | Ajou University Industry-Academic Cooperation Foundation | Human antibody having high affinity to human il-4 receptor alpha, and use thereof |
| CN111494626B (zh) * | 2018-12-25 | 2022-06-21 | 江苏荃信生物医药股份有限公司 | 用于治疗il-4和/或il-13介导的信号转导相关的疾病的药物组合物 |
| MX2021007845A (es) * | 2018-12-27 | 2021-09-30 | Akeso Biopharma Inc | Anticuerpos contra il-4ra humano y uso de los mismos. |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| CN111686247B (zh) * | 2019-03-13 | 2022-07-29 | 苏州康乃德生物医药有限公司 | 包含人白介素-4受体α的抗体的液体组合物 |
| CN111592597B (zh) * | 2019-05-29 | 2022-04-26 | 山东博安生物技术股份有限公司 | 白介素4受体(il-4r)结合蛋白及其用途 |
| TWI865727B (zh) | 2020-02-21 | 2024-12-11 | 大陸商江蘇恆瑞醫藥股份有限公司 | 一種抗il-4r抗體醫藥組成物及其用途 |
| US20230131324A1 (en) * | 2020-02-24 | 2023-04-27 | Medimmune, Llc | Formulations of anti-endothelial lipase antibodies |
| KR20220147642A (ko) * | 2020-02-27 | 2022-11-03 | 치아타이 티안큉 파마수티컬 그룹 주식회사 | Il4r에 결합하는 항체 및 이의 용도 |
| RS65199B1 (sr) | 2020-03-26 | 2024-03-29 | Univ Vanderbilt | Humana monoklonska antitela na teški akutni respiratorni sindrom koronavirus 2 (sars-cov-2) |
| CN113527485B (zh) * | 2020-04-17 | 2024-11-15 | 湖南麦济生物技术股份有限公司 | 抗人白细胞介素-4受体α抗体及其制备方法和应用 |
| CN113549151A (zh) * | 2020-04-24 | 2021-10-26 | 苏州康乃德生物医药有限公司 | 与人IL-4Rα中特定表位结合的抗体及其应用 |
| KR102169476B1 (ko) * | 2020-05-20 | 2020-10-23 | (주)신테카바이오 | 제2형 중증급성호흡기증후군 코로나바이러스 감염 질환의 예방 또는 치료용 조성물 |
| CN113797331A (zh) * | 2020-06-16 | 2021-12-17 | 三生国健药业（上海）股份有限公司 | 一种稳定的抗IL-4Rα单克隆抗体液体制剂 |
| CN111690066B (zh) * | 2020-06-22 | 2022-07-22 | 南京融捷康生物科技有限公司 | 抗IL-4Rα的单域抗体以及应用和药物 |
| KR20230045613A (ko) * | 2020-08-10 | 2023-04-04 | 아스트라제네카 유케이 리미티드 | Covid-19의 치료 및 예방을 위한 sars-cov-2 항체 |
| EP4211169A4 (en) * | 2020-09-10 | 2024-12-04 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | ANTIBODIES THAT SPECIFICALLY RECOGNIZE THE INTERLEUKIN-4 RECEPTOR ALPHA AND USES THEREOF |
| TW202342510A (zh) | 2022-02-18 | 2023-11-01 | 英商Ｒｑ生物科技有限公司 | 抗體 |
| KR20240038841A (ko) * | 2022-09-16 | 2024-03-26 | 연세대학교 산학협력단 | 신규한 인간 인터류킨-4 수용체 결합 나노바디 및 이의 용도 |
| WO2024259656A1 (en) * | 2023-06-21 | 2024-12-26 | Shanghai Mabgeek Biotech Co., Ltd. | Formulation of an anti-il-4 receptor alpha mab or an antigen-binding fragment thereof comprising 2hpbetacd and leucine |
| CN119215163A (zh) * | 2023-06-30 | 2024-12-31 | 百奥泰生物制药股份有限公司 | 抗IL-4Rα抗体制剂及其制备方法和应用 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1409018B1 (en) * | 2001-07-25 | 2010-01-06 | Facet Biotech Corporation | Stable lyophilized pharmaceutical formulation the igg antibody daclizumab |
| CN104788563A (zh) * | 2007-12-21 | 2015-07-22 | 米迪缪尼有限公司 | 白介素-4受体α(IL-4Rα)-173的结合成员 |
| US8092804B2 (en) * | 2007-12-21 | 2012-01-10 | Medimmune Limited | Binding members for interleukin-4 receptor alpha (IL-4Rα)-173 |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| NZ609557A (en) * | 2010-10-06 | 2014-12-24 | Regeneron Pharma | Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies |
| US8613919B1 (en) * | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
-
2015
- 2015-09-02 WO PCT/EP2015/070091 patent/WO2016034648A1/en active Application Filing
- 2015-09-02 CA CA2959571A patent/CA2959571A1/en not_active Abandoned
- 2015-09-02 AU AU2015310879A patent/AU2015310879A1/en not_active Abandoned
- 2015-09-02 JP JP2017512291A patent/JP2017527560A/ja active Pending
- 2015-09-02 BR BR112017003419A patent/BR112017003419A2/pt not_active Application Discontinuation
- 2015-09-02 SG SG11201701458YA patent/SG11201701458YA/en unknown
- 2015-09-02 US US15/508,647 patent/US20170281769A1/en not_active Abandoned
- 2015-09-02 EP EP15757288.4A patent/EP3188757A1/en not_active Withdrawn
- 2015-09-02 RU RU2017107847A patent/RU2017107847A/ru not_active Application Discontinuation
- 2015-09-02 CN CN201580047598.2A patent/CN106604744A/zh active Pending
- 2015-09-02 KR KR1020177008571A patent/KR20170044739A/ko not_active Withdrawn
-
2017
- 2017-01-30 IL IL250363A patent/IL250363A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2016034648A1 (en) | 2016-03-10 |
| RU2017107847A (ru) | 2018-10-03 |
| US20170281769A1 (en) | 2017-10-05 |
| KR20170044739A (ko) | 2017-04-25 |
| CN106604744A (zh) | 2017-04-26 |
| EP3188757A1 (en) | 2017-07-12 |
| JP2017527560A (ja) | 2017-09-21 |
| SG11201701458YA (en) | 2017-03-30 |
| CA2959571A1 (en) | 2016-03-10 |
| IL250363A0 (en) | 2017-03-30 |
| AU2015310879A1 (en) | 2017-03-02 |
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