MX363380B - Formulacion de anticuerpos. - Google Patents
Formulacion de anticuerpos.Info
- Publication number
- MX363380B MX363380B MX2014015262A MX2014015262A MX363380B MX 363380 B MX363380 B MX 363380B MX 2014015262 A MX2014015262 A MX 2014015262A MX 2014015262 A MX2014015262 A MX 2014015262A MX 363380 B MX363380 B MX 363380B
- Authority
- MX
- Mexico
- Prior art keywords
- iii
- polysorbate
- histidine
- stabilizer
- surfactant
- 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
-
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/26—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
- A61K9/0019—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
- 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
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- 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
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- 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
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Oncology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente invención se refiere a una composición acuosa que tiene un pH de 6.0 y que comprende un anticuerpo del Receptor de Factor de Activación de células B (BAFFR) hipofucosilado o no fucosilado en donde el anticuerpo tiene una concentración de 150 mg/mL y en donde dicho anticuerpo anti-BAFFR comprende CDR1, CDR2 y CDR3 de cadena pesada de SEQ ID Nos: 3, 4 y 5 respectivamente, y CDR1, CDR2 y CDR3 de cadena ligera de SEQ ID Nos; 6, 7 y 8, and: (a)(i) sacarosa 220 m M como estabilizante, (ii) histidina 20 m M como agente agente regulador del Ph (iii) polisorbato 20 al 0.04% como tensoactivo; o (b) (i) trehalosa 200 mM como estabilizador , (iii) histidina 20 mM como agente regulador de pH, (iii) polisorbato 20 al 0.04% como tensoactivo; o (c) (i) sacarosa 120 m M como estabilizador, (ii) histidina 20 mM como agente regulador del p H, (iii) polisorbato 20 al 0.04$ como tensoactivo, y (iv) 50 mM de arginina.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261658472P | 2012-06-12 | 2012-06-12 | |
| PCT/IB2013/054777 WO2013186700A1 (en) | 2012-06-12 | 2013-06-11 | Antibody formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2014015262A MX2014015262A (es) | 2015-06-23 |
| MX363380B true MX363380B (es) | 2019-03-21 |
Family
ID=48914378
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2014015262A MX363380B (es) | 2012-06-12 | 2013-06-11 | Formulacion de anticuerpos. |
Country Status (35)
| Country | Link |
|---|---|
| US (4) | US9216219B2 (es) |
| EP (2) | EP3593814B1 (es) |
| JP (1) | JP6265978B2 (es) |
| KR (1) | KR102124820B1 (es) |
| CN (1) | CN104363920B (es) |
| AR (1) | AR091413A1 (es) |
| AU (1) | AU2013276112B2 (es) |
| BR (1) | BR112014030820B1 (es) |
| CA (1) | CA2875386C (es) |
| CL (1) | CL2014003370A1 (es) |
| CO (1) | CO7151487A2 (es) |
| CY (1) | CY1122181T1 (es) |
| DK (1) | DK2858671T3 (es) |
| EA (1) | EA033373B1 (es) |
| EC (1) | ECSP15017314A (es) |
| ES (1) | ES2751659T3 (es) |
| GT (1) | GT201400285A (es) |
| HR (1) | HRP20191827T1 (es) |
| HU (1) | HUE045523T2 (es) |
| IL (1) | IL235966B (es) |
| LT (1) | LT2858671T (es) |
| MA (1) | MA37616A1 (es) |
| MX (1) | MX363380B (es) |
| MY (1) | MY179818A (es) |
| NZ (1) | NZ630885A (es) |
| PE (1) | PE20150200A1 (es) |
| PH (1) | PH12014502778A1 (es) |
| PL (1) | PL2858671T3 (es) |
| PT (1) | PT2858671T (es) |
| SG (1) | SG11201408174UA (es) |
| SI (1) | SI2858671T1 (es) |
| TN (1) | TN2014000488A1 (es) |
| TW (1) | TWI653983B (es) |
| WO (1) | WO2013186700A1 (es) |
| ZA (1) | ZA201408547B (es) |
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|---|---|---|---|---|
| RS62853B1 (sr) | 2010-01-06 | 2022-02-28 | Takeda Pharmaceuticals Co | Proteini koji vezuju kalikrein plazme |
| US9458240B2 (en) | 2010-12-10 | 2016-10-04 | Novartis Pharma Ag | Anti-BAFFR antibody formulations |
| AU2012204202A1 (en) | 2011-01-06 | 2013-07-11 | Dyax Corp. | Plasma kallikrein binding proteins |
| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| TWI660972B (zh) | 2012-09-10 | 2019-06-01 | 愛爾蘭商尼歐托普生物科學公司 | 抗ｍｃａｍ抗體及相關使用方法 |
| CA3208188A1 (en) | 2013-03-15 | 2014-09-25 | Takeda Pharmaceutical Company Limited | Anti-plasma kallikrein antibodies |
| US10513555B2 (en) * | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| CN104730237A (zh) * | 2013-12-23 | 2015-06-24 | 国家纳米科学中心 | 试纸及其应用以及检测甲胎蛋白抗原、乙肝表面抗原或HIV的gp41抗体的方法 |
| PT3096798T (pt) | 2014-01-21 | 2021-02-25 | Dyax Corp | Proteínas de ligação à calicreína plasmática e seus usos no tratamento de angioedema hereditário |
| CA2938933A1 (en) | 2014-03-12 | 2015-09-17 | Prothena Biosciences Limited | Anti-laminin4 antibodies specific for lg4-5 |
| JP6728053B2 (ja) | 2014-03-12 | 2020-07-22 | プロセナ バイオサイエンシーズ リミテッド | 抗ｍｃａｍ抗体及び関連する使用方法 |
| AU2015235967B2 (en) | 2014-03-27 | 2020-10-22 | Takeda Pharmaceutical Company Limited | Compositions and methods for treatment of diabetic macular edema |
| KR101597037B1 (ko) | 2014-06-26 | 2016-02-24 | 엘지디스플레이 주식회사 | 구동소자의 전기적 특성 편차를 보상할 수 있는 유기발광 표시장치 |
| TWI761959B (zh) | 2014-11-07 | 2022-04-21 | 瑞士商諾華公司 | 治療眼部疾病之方法 |
| US10464999B2 (en) | 2015-01-28 | 2019-11-05 | Prothena Biosciences Limited | Anti-transthyretin antibodies |
| IL305207A (en) * | 2015-03-30 | 2023-10-01 | Takeda Pharmaceuticals Co | Plasma kallikrein inhibitors and their uses to prevent the outbreak of hereditary angioedema |
| WO2017046776A2 (en) * | 2015-09-16 | 2017-03-23 | Prothena Biosciences Limited | Use of anti-mcam antibodies for treatment or prophylaxis of giant cell arteritis, polymyalgia rheumatica or takayasu's arteritis |
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| KR102617264B1 (ko) | 2016-10-19 | 2023-12-29 | 인벤라 인코포레이티드 | 항체 구조물 |
| JP7681879B2 (ja) | 2016-12-22 | 2025-05-23 | ウニヴェルシタ・デリ・ストゥディ・マニャ・グレチア・カタンツァーロ | Ｃｄ４３の固有のシアログリコシル化がん関連エピトープを標的化するモノクローナル抗体 |
| CN110366429B (zh) * | 2017-03-01 | 2024-10-11 | 免疫医疗有限公司 | 单克隆抗体的配制品 |
| WO2018162446A1 (en) * | 2017-03-06 | 2018-09-13 | Merck Patent Gmbh | Aqueous anti-pd-l1 antibody formulation |
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| JOP20190260A1 (ar) * | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| KR20230066126A (ko) * | 2017-07-27 | 2023-05-12 | 알렉시온 파마슈티칼스, 인코포레이티드 | 고농도 항-c5 항체 제형 |
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| WO2019071206A1 (en) | 2017-10-06 | 2019-04-11 | Prothena Biosciences Limited | METHODS OF DETECTING TRANSTHYRETIN |
| MX2020005433A (es) * | 2017-11-29 | 2020-08-27 | Prothena Biosciences Ltd | Formulacion liofilizada de un anticuerpo monoclonal contra la transtirretina. |
| CA3102349A1 (en) | 2018-06-05 | 2019-12-12 | King's College London | Btnl3/8 targeting constructs for delivery of payloads to the gastrointestinal system |
| WO2020006266A1 (en) | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| MX2021007393A (es) * | 2018-12-18 | 2021-09-23 | Novartis Ag | Formulacion de solucion de proteinas que contiene una alta concentracion de un anticuerpo anti-vegf. |
| SG11202108627SA (en) | 2019-02-18 | 2021-09-29 | Lilly Co Eli | Therapeutic antibody formulation |
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| CN115073598B (zh) * | 2021-03-15 | 2024-02-20 | 盛禾(中国)生物制药有限公司 | 一种抗baffr抗体及其应用 |
| EP4334351A1 (en) | 2021-05-04 | 2024-03-13 | Novartis AG | Treatment for systemic lupus erythematosus using anti-baffr antibodies |
| CN117203240A (zh) | 2021-05-04 | 2023-12-08 | 诺华股份有限公司 | 使用抗baffr抗体治疗狼疮肾炎 |
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| CN116712390B (zh) * | 2023-08-04 | 2023-11-14 | 上海览屹医药科技有限公司 | 一种高浓度高稳定性的抗体制剂及其制备方法 |
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| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
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2013
- 2013-06-07 US US13/912,355 patent/US9216219B2/en active Active
- 2013-06-10 MA MA37616A patent/MA37616A1/fr unknown
- 2013-06-11 LT LT13744818T patent/LT2858671T/lt unknown
- 2013-06-11 DK DK13744818.9T patent/DK2858671T3/da active
- 2013-06-11 ES ES13744818T patent/ES2751659T3/es active Active
- 2013-06-11 CN CN201380031181.8A patent/CN104363920B/zh active Active
- 2013-06-11 EP EP19185836.4A patent/EP3593814B1/en active Active
- 2013-06-11 TW TW102120795A patent/TWI653983B/zh active
- 2013-06-11 EP EP13744818.9A patent/EP2858671B1/en active Active
- 2013-06-11 SG SG11201408174UA patent/SG11201408174UA/en unknown
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2014
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2015
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2017
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