AR100268A1 - Formulación líquida que comprende compuesto neutralizante de gm-csf - Google Patents
Formulación líquida que comprende compuesto neutralizante de gm-csfInfo
- Publication number
- AR100268A1 AR100268A1 ARP150101336A ARP150101336A AR100268A1 AR 100268 A1 AR100268 A1 AR 100268A1 AR P150101336 A ARP150101336 A AR P150101336A AR P150101336 A ARP150101336 A AR P150101336A AR 100268 A1 AR100268 A1 AR 100268A1
- Authority
- AR
- Argentina
- Prior art keywords
- composition according
- csf
- neutralizing compound
- neutralizes
- formulation
- Prior art date
Links
Classifications
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- 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
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- 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
-
- 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
- A61P37/08—Antiallergic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- C07K16/243—Colony Stimulating Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Dermatology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Formulaciones acuosas que comprenden un compuesto neutralizante que neutraliza GM-CSF en las concentraciones de por lo menos alrededor de 20 mg/ml, un modificador de tonicidad, un buffer y uno o más de agentes tensioactivos, los aminoácidos, antioxidantes y/o queladores, en donde la composición es estable. Los ingredientes de la formulación preferentemente proporcionan estabilidad al compuesto que neutraliza GM-CSF en vista del almacenamiento prolongado. En un aspecto preferido, la formulación es para usar en tratamiento, preferentemente para usar en el tratamiento de trastornos inflamatorios y autoinmunes, preferentemente incluyendo trastornos alérgicos y psoriáticos, además de alteraciones artríticas y asmáticas. Además, se proporciona un kit que comprende la formulación. Reivindicación 4: La composición de acuerdo con la reivindicación 1 hasta 3, en donde el modificador de tonicidad se selecciona de manitol, sorbitol, sacarosa y/o trehalosa. Reivindicación 5: La composición de acuerdo con cualquiera de las reivindicaciones 1 hasta 4, en donde el buffer se selecciona de un buffer de histidina, acetato y/o de citrato. Reivindicación 6: La composición de acuerdo con cualquiera de los puntos 1 hasta 5, en donde el agente tensioactivo se selecciona de uno o más de polisorbato 20, polisorbato 80, poloxámeros y combinaciones de los anteriores. Reivindicación 15: La composición de acuerdo con cualquiera de las reivindicaciones 1 hasta 14, en donde el compuesto que neutraliza GM-CSF se selecciona del grupo que consiste en un polipéptido, un péptido mimético, un ácido nucleico, y una molécula pequeña. Reivindicación 16: La composición de acuerdo con la reivindicación 15, en donde el polipéptido es un anticuerpo o uno de sus fragmentos funcionales que se une a un GM-CSF o al receptor de GM-CSF. Reivindicación 17: La composición de acuerdo con la reivindicación 16, en donde el anticuerpo o el fragmento funcional del mismo es un anticuerpo monoclonal humano o uno de sus fragmentos funcionales. Reivindicación 18: La composición de acuerdo con cualquiera de las reivindicaciones que anteceden que comprende i) alrededor de 50 mg/ml hasta alrededor de 180 mg/ml de un compuesto neutralizante que neutraliza GM-CSF, ii) alrededor de 5% (p/v) de sorbitol, iii) alrededor de 30 mM de L-histidina y iv) desde alrededor de 0,001% hasta alrededor de 1% (p/v) de agente tensioactivo y v) tiene un pH de alrededor de 5,8.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14167405 | 2014-05-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR100268A1 true AR100268A1 (es) | 2016-09-21 |
Family
ID=50721582
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP150101336A AR100268A1 (es) | 2014-05-07 | 2015-05-04 | Formulación líquida que comprende compuesto neutralizante de gm-csf |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US11173208B2 (es) |
| EP (1) | EP3139960B1 (es) |
| JP (1) | JP6769879B2 (es) |
| KR (1) | KR102385802B1 (es) |
| CN (1) | CN106659785B (es) |
| AR (1) | AR100268A1 (es) |
| AU (1) | AU2015257798C1 (es) |
| BR (1) | BR112016025126B1 (es) |
| CA (1) | CA2946230A1 (es) |
| EA (1) | EA201691883A1 (es) |
| ES (1) | ES2974895T3 (es) |
| MX (1) | MX2016014411A (es) |
| PH (1) | PH12016502100A1 (es) |
| TW (1) | TWI682788B (es) |
| WO (1) | WO2015169742A1 (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20190255A1 (ar) | 2017-04-28 | 2019-10-27 | Amgen Inc | صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها |
| CN107167613B (zh) * | 2017-06-22 | 2018-10-02 | 深圳清华大学研究院 | 用于等离子体金芯片的蛋白点样缓冲液 |
| US20240336685A1 (en) * | 2018-10-01 | 2024-10-10 | Amgen Inc. | Methods for reducing aggregation of bispecific antibodies |
| US11684655B2 (en) | 2019-05-31 | 2023-06-27 | Spectrum Pharmaceuticals, Inc. | Methods of treating neutorpenia using G-CSF protein complex |
| KR20220099585A (ko) * | 2019-10-25 | 2022-07-13 | 암젠 인크 | 낮은 단백질 농도에서 단백질 손실을 최소화하기 위한 조성물 및 방법 |
| WO2022115914A1 (en) * | 2020-12-04 | 2022-06-09 | Csl Innovation | Methods for treating inflammatory skin conditions |
| KR102375269B1 (ko) * | 2021-01-27 | 2022-03-17 | 한미약품 주식회사 | 단백질 액상 제제 및 이의 제조방법 |
| CN117615788A (zh) * | 2021-05-12 | 2024-02-27 | 安奈普泰斯生物有限公司 | 抗体组合物 |
| WO2024114735A1 (en) * | 2022-12-01 | 2024-06-06 | I-Mab Biopharma (Hangzhou) Co., Ltd. | Liquid pharmaceutical formulation of anti-gm-csf antibody and uses thereof |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2916711A1 (de) | 1979-04-25 | 1980-11-06 | Behringwerke Ag | Blutgerinnungsfaktoren und verfahren zu ihrer herstellung |
| US4783441A (en) | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| DE3583880D1 (de) | 1984-04-09 | 1991-10-02 | Takeda Chemical Industries Ltd | Stabile interleukin-2-zusammensetzung. |
| WO1988007089A1 (en) | 1987-03-18 | 1988-09-22 | Medical Research Council | Altered antibodies |
| GB8903593D0 (en) | 1989-02-16 | 1989-04-05 | Pafra Ltd | Storage of materials |
| US5747032A (en) | 1990-08-10 | 1998-05-05 | Amrad Corporation Limited | Monoclonal antibody to human granulocyte macrophage colony stimulating factor |
| US5580856A (en) | 1994-07-15 | 1996-12-03 | Prestrelski; Steven J. | Formulation of a reconstituted protein, and method and kit for the production thereof |
| ES2434840T3 (es) * | 1995-07-27 | 2013-12-17 | Genentech, Inc. | Formulación de proteína liofilizada isotónica estable |
| US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| KR100508289B1 (ko) | 1998-04-21 | 2005-08-17 | 마이크로메트 에이지 | Ｃｄ１９×ｃｄ３ 특이 폴리펩티드 및 그의 용도 |
| DK1441589T3 (da) * | 2001-11-08 | 2012-08-06 | Abbott Biotherapeutics Corp | Stabil, flydende, farmaceutisk sammensætning af IgG-antistoffer |
| ES2618832T3 (es) | 2002-02-27 | 2017-06-22 | Immunex Corporation | Composición TNFR-FC estabilizada que comprende arginina |
| US7511476B2 (en) * | 2005-01-04 | 2009-03-31 | Digisensors, Inc. | Electromagnetic sensor systems and methods of use thereof |
| EA013162B1 (ru) * | 2005-04-18 | 2010-02-26 | Микромет Аг | Антитела-нейтрализаторы гранулоцитарно-макрофагального колониестимулирующего фактора человека |
| JP5295759B2 (ja) | 2005-05-18 | 2013-09-18 | モルフォシス・アクチェンゲゼルシャフト | 抗ｇｍ−ｃｓｆ抗体とその使用 |
| JP4736037B2 (ja) * | 2005-10-26 | 2011-07-27 | 株式会社イーベック | ヒトｇｍ−ｃｓｆに結合するヒトのモノクローナル抗体並びにその抗原結合部分 |
| CA2641169C (en) | 2006-02-08 | 2017-05-02 | Morphotek, Inc. | Antigenic gm-csf peptides and antibodies to gm-csf |
| SI1999152T1 (sl) | 2006-03-27 | 2013-02-28 | Medimmune Limited | Vezni äślen za gm-csf receptor |
| EP1970384A1 (en) * | 2007-03-14 | 2008-09-17 | Ganymed Pharmaceuticals AG | Monoclonal antibodies for treatment of cancer |
| AU2008269086B2 (en) | 2007-06-25 | 2014-06-12 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| TW200918553A (en) * | 2007-09-18 | 2009-05-01 | Amgen Inc | Human GM-CSF antigen binding proteins |
| WO2009064399A1 (en) | 2007-11-13 | 2009-05-22 | Evec Inc. | Monoclonal antibodies that bind to hgm-csf and medical compositions comprising same |
| WO2009134805A2 (en) | 2008-04-28 | 2009-11-05 | Kalobios Pharmaceuticals, Inc. | Antibodies to granulocyte-macrophage colony-stimulating factor |
| CA2738243C (en) * | 2008-10-29 | 2020-09-29 | Wyeth Llc | Formulations of single domain antigen binding molecules |
| BR112012013148A2 (pt) * | 2009-12-29 | 2017-03-21 | F Hoffmann - La Roche Ag | formulação farmacêutica e uso |
| AU2013320261A1 (en) * | 2012-09-20 | 2015-04-09 | Morphosys Ag | Treatment for rheumatoid arthritis |
| AR093297A1 (es) * | 2012-10-31 | 2015-05-27 | Amgen Res (Munich) Gmbh | Formulacion liquida que comprende un compuesto neutralizante de gm-csf |
-
2015
- 2015-05-04 BR BR112016025126-1A patent/BR112016025126B1/pt active IP Right Grant
- 2015-05-04 CA CA2946230A patent/CA2946230A1/en active Pending
- 2015-05-04 MX MX2016014411A patent/MX2016014411A/es unknown
- 2015-05-04 EA EA201691883A patent/EA201691883A1/ru unknown
- 2015-05-04 EP EP15720968.5A patent/EP3139960B1/en active Active
- 2015-05-04 ES ES15720968T patent/ES2974895T3/es active Active
- 2015-05-04 AU AU2015257798A patent/AU2015257798C1/en active Active
- 2015-05-04 KR KR1020167031014A patent/KR102385802B1/ko active IP Right Grant
- 2015-05-04 CN CN201580037108.0A patent/CN106659785B/zh active Active
- 2015-05-04 WO PCT/EP2015/059709 patent/WO2015169742A1/en active Application Filing
- 2015-05-04 US US15/307,214 patent/US11173208B2/en active Active
- 2015-05-04 AR ARP150101336A patent/AR100268A1/es not_active Application Discontinuation
- 2015-05-04 JP JP2016566811A patent/JP6769879B2/ja active Active
- 2015-05-07 TW TW104114614A patent/TWI682788B/zh active
-
2016
- 2016-10-20 PH PH12016502100A patent/PH12016502100A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20170252436A1 (en) | 2017-09-07 |
| AU2015257798C1 (en) | 2020-10-22 |
| PH12016502100A1 (en) | 2017-02-06 |
| BR112016025126A2 (pt) | 2018-02-20 |
| EP3139960B1 (en) | 2024-01-17 |
| KR102385802B1 (ko) | 2022-04-13 |
| TW201622702A (zh) | 2016-07-01 |
| EP3139960A1 (en) | 2017-03-15 |
| KR20160149210A (ko) | 2016-12-27 |
| JP6769879B2 (ja) | 2020-10-14 |
| WO2015169742A1 (en) | 2015-11-12 |
| CN106659785A (zh) | 2017-05-10 |
| TWI682788B (zh) | 2020-01-21 |
| JP2017514868A (ja) | 2017-06-08 |
| ES2974895T3 (es) | 2024-07-02 |
| US11173208B2 (en) | 2021-11-16 |
| EA201691883A1 (ru) | 2017-05-31 |
| AU2015257798A1 (en) | 2016-11-17 |
| MX2016014411A (es) | 2017-04-06 |
| AU2015257798B2 (en) | 2020-04-23 |
| BR112016025126A8 (pt) | 2022-08-09 |
| BR112016025126B1 (pt) | 2024-02-15 |
| CN106659785B (zh) | 2021-04-30 |
| CA2946230A1 (en) | 2015-11-12 |
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