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
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)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (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 (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112018002196A8 (pt) | 2015-08-19 | 2021-05-04 | Astrazeneca Ab | formulação anti-ifnar1 estável |
| 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 |
| SG11202003754YA (en) * | 2017-05-16 | 2020-05-28 | Bhamis 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 |
| CN115991781A (zh) * | 2018-08-24 | 2023-04-21 | 江苏恒瑞医药股份有限公司 | 结合人il-4r的抗体、其抗原结合片段及其医药用途 |
| KR102330596B1 (ko) * | 2018-11-09 | 2021-11-26 | 아주대학교산학협력단 | 인간 il-4 수용체 알파에 대한 고친화도 인간 항체 및 이의 용도 |
| CN110746507B (zh) * | 2018-12-25 | 2020-06-26 | 江苏荃信生物医药有限公司 | 抗人白介素4受体α单克隆抗体及其应用 |
| BR112021012647A2 (pt) * | 2018-12-27 | 2021-09-14 | Akeso Biopharma, Inc | Anticorpo, polipeptídeo isolado, polinucleotídeo isolado, vetor, célula hospedeira, métodos para preparar o anticorpo e para a prevenção e/ou tratamento e/ou tratamento adjuvante e/ou diagnóstico de uma doença, conjugado de anticorpo, anticorpo multiespecífico, proteína de fusão, composição farmacêutica, kit, usos do anticorpo, método in vivo ou in vitro, célula de hibridoma e anticorpo monoclonal |
| UA128098C2 (uk) | 2019-02-18 | 2024-04-03 | Елі Ліллі Енд Компані | Водна фармацевтична композиція антитіла проти il-17a |
| 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 |
| KR20220143882A (ko) | 2020-02-21 | 2022-10-25 | 지앙수 헨그루이 파마슈티컬스 컴퍼니 리미티드 | 항-il-4r 항체를 함유하는 약학적 조성물 및 이의 용도 |
| WO2021173537A1 (en) * | 2020-02-24 | 2021-09-02 | Medimmune, Llc | Formulations of anti-endothelial lipase antibodies |
| MX2022010665A (es) * | 2020-02-27 | 2022-09-23 | Chia Tai Tianqing Pharmaceutical Group Co Ltd | Anticuerpos que se unen al receptor de interleucina 4 (il4r) y usos de los mismos. |
| JP7454882B2 (ja) * | 2020-04-17 | 2024-03-25 | シャンハイマブギークバイオテック．カンパニー，リミティド | 抗ヒトインターロイキン－４受容体α抗体及びその調製方法並びに使用 |
| 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 |
| CN114957472B (zh) * | 2020-06-22 | 2023-10-31 | 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 |
| WO2022034044A1 (en) * | 2020-08-10 | 2022-02-17 | Astrazeneca Uk Limited | Sars-cov-2 antibodies for treatment and prevention of covid-19 |
| CN114555639B (zh) * | 2020-09-10 | 2023-12-12 | 舒泰神（北京）生物制药股份有限公司 | 特异性识别白细胞介素-4受体α的抗体及其用途 |
| 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 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4317010B2 (ja) * | 2001-07-25 | 2009-08-19 | ピーディーエル バイオファーマ，インコーポレイティド | ＩｇＧ抗体の安定な凍結乾燥医薬製剤 |
| US8092804B2 (en) * | 2007-12-21 | 2012-01-10 | Medimmune Limited | Binding members for interleukin-4 receptor alpha (IL-4Rα)-173 |
| KR101759457B1 (ko) * | 2007-12-21 | 2017-07-31 | 메디뮨 리미티드 | 인터루킨-4 수용체 알파(ＩＬ-4Ｒα)에 대한 결합 구성원-173 |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| PL3354280T3 (pl) * | 2010-10-06 | 2021-02-08 | Regeneron Pharmaceuticals, Inc. | Stabilizowane preparaty zawierające przeciwciała przeciwko receptorowi interleukiny 4 (IL-4R) |
| US8613919B1 (en) * | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
-
2015
- 2015-09-02 BR BR112017003419A patent/BR112017003419A2/pt not_active Application Discontinuation
- 2015-09-02 JP JP2017512291A patent/JP2017527560A/ja active Pending
- 2015-09-02 EP EP15757288.4A patent/EP3188757A1/en not_active Withdrawn
- 2015-09-02 AU AU2015310879A patent/AU2015310879A1/en not_active Abandoned
- 2015-09-02 CA CA2959571A patent/CA2959571A1/en not_active Abandoned
- 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 CN CN201580047598.2A patent/CN106604744A/zh active Pending
- 2015-09-02 WO PCT/EP2015/070091 patent/WO2016034648A1/en active Application Filing
- 2015-09-02 KR KR1020177008571A patent/KR20170044739A/ko unknown
- 2015-09-02 RU RU2017107847A patent/RU2017107847A/ru not_active Application Discontinuation
-
2017
- 2017-01-30 IL IL250363A patent/IL250363A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2015310879A1 (en) | 2017-03-02 |
| CN106604744A (zh) | 2017-04-26 |
| US20170281769A1 (en) | 2017-10-05 |
| SG11201701458YA (en) | 2017-03-30 |
| IL250363A0 (en) | 2017-03-30 |
| KR20170044739A (ko) | 2017-04-25 |
| RU2017107847A (ru) | 2018-10-03 |
| CA2959571A1 (en) | 2016-03-10 |
| JP2017527560A (ja) | 2017-09-21 |
| WO2016034648A1 (en) | 2016-03-10 |
| EP3188757A1 (en) | 2017-07-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B11A | Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing | ||
| B11Y | Definitive dismissal - extension of time limit for request of examination expired [chapter 11.1.1 patent gazette] |