BR112015009259B8 - Composição aquosa compreendendo o composto de neutralização do gm-csf - Google Patents
Composição aquosa compreendendo o composto de neutralização do gm-csfInfo
- Publication number
- BR112015009259B8 BR112015009259B8 BR112015009259A BR112015009259A BR112015009259B8 BR 112015009259 B8 BR112015009259 B8 BR 112015009259B8 BR 112015009259 A BR112015009259 A BR 112015009259A BR 112015009259 A BR112015009259 A BR 112015009259A BR 112015009259 B8 BR112015009259 B8 BR 112015009259B8
- Authority
- BR
- Brazil
- Prior art keywords
- formulation
- csf
- compound
- aqueous composition
- composition including
- 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
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
- 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
- A61P37/02—Immunomodulators
-
- 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
-
- 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
-
- 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
-
- 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
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)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Pulmonology (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (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
FORMULAÇÃO LÍQUIDA COMPREENDENDO O COMPOSTO DE NEUTRALIZAÇÃO DO GM-CSF. A presente invenção refere-se às formulações aquosas compreendendo um composto de neutralização do GM-CSF em concentrações de pelo menos cerca de 20 mg/ml, um modificador da tonicidade e um tampão, em que a composição é estável. Os ingredientes da formulação preferivelmente fornecem estabilidade ao composto de neutralização do GM-CSF em vista da armazenagem a longo prazo. Em um aspecto preferido, a formulação é para uso em terapia, de preferência para uso no tratamento de distúrbios inflamatórios e autoimunes, preferivelmente incluindo os distúrbios alérgicos e de psoríase, assim como doenças artríticas e asmáticas. Além disso, é fornecido um kit compreendendo a formulação da invenção.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261720892P | 2012-10-31 | 2012-10-31 | |
EP12199191 | 2012-12-21 | ||
PCT/EP2013/072761 WO2014068026A1 (en) | 2012-10-31 | 2013-10-31 | Liquid formulation comprising gm-csf neutralizing compound |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112015009259A2 BR112015009259A2 (pt) | 2017-08-22 |
BR112015009259B1 BR112015009259B1 (pt) | 2022-05-17 |
BR112015009259B8 true BR112015009259B8 (pt) | 2022-08-23 |
Family
ID=47504727
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112015009259A BR112015009259B8 (pt) | 2012-10-31 | 2013-10-31 | Composição aquosa compreendendo o composto de neutralização do gm-csf |
Country Status (15)
Country | Link |
---|---|
US (2) | US9919051B2 (pt) |
EP (2) | EP3744344A1 (pt) |
JP (1) | JP6346189B2 (pt) |
KR (1) | KR102106914B1 (pt) |
CN (1) | CN104768580B (pt) |
AR (1) | AR093297A1 (pt) |
AU (1) | AU2013340845B2 (pt) |
BR (1) | BR112015009259B8 (pt) |
CA (1) | CA2889307C (pt) |
EA (1) | EA032829B1 (pt) |
HK (1) | HK1214761A1 (pt) |
MX (1) | MX363807B (pt) |
PH (1) | PH12015500864A1 (pt) |
TW (1) | TWI639440B (pt) |
WO (1) | WO2014068026A1 (pt) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2014314053C1 (en) | 2013-08-30 | 2023-11-02 | Takeda Pharmaceutical Company Limited | Antibodies neutralizing GM-CSF for use in the treatment of rheumatoid arthritis or as analgesics |
CN106659785B (zh) * | 2014-05-07 | 2021-04-30 | 武田有限公司 | 包含gm-csf中和化合物的液体制剂 |
EP2946766B1 (en) * | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
EP2946767B1 (en) | 2014-05-23 | 2016-10-05 | Ares Trading S.A. | Liquid pharmaceutical composition |
LT2946765T (lt) | 2014-05-23 | 2016-11-25 | Ares Trading S.A. | Skysta farmacinė kompozicija |
CN109219616B (zh) * | 2016-09-19 | 2022-10-21 | 天境生物科技(杭州)有限公司 | Gm-csf抗体及其用途 |
EP3589318A1 (en) * | 2017-03-01 | 2020-01-08 | MedImmune Limited | Formulations of monoclonal antibodies |
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 |
WO2021011404A1 (en) * | 2019-07-12 | 2021-01-21 | Contrafect Corporation | Therapeutic protein formulations comprising antibodies and uses thereof |
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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 |
EP0158487B1 (en) | 1984-04-09 | 1991-08-28 | Takeda Chemical Industries, Ltd. | Stable composition of interleukin-2 |
GB8624899D0 (en) | 1986-10-17 | 1986-11-19 | Sandoz Ltd | Monoclonal antibodies |
WO1988007089A1 (en) | 1987-03-18 | 1988-09-22 | Medical Research Council | Altered antibodies |
US5070013A (en) | 1988-05-31 | 1991-12-03 | Schering Corporation | Immunochemical assay for human granulocyte-macrophage colony stimulating factor |
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 |
CA2060741A1 (en) | 1991-02-11 | 1992-08-12 | Robert S. Greenfield | Gm-csf inhibiting oligopeptides |
US5580856A (en) | 1994-07-15 | 1996-12-03 | Prestrelski; Steven J. | Formulation of a reconstituted protein, and method and kit for the production thereof |
US6309636B1 (en) | 1995-09-14 | 2001-10-30 | Cancer Research Institute Of Contra Costa | Recombinant peptides derived from the Mc3 anti-BA46 antibody, methods of use thereof, and methods of humanizing antibody peptides |
US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
GB9722131D0 (en) | 1997-10-20 | 1997-12-17 | Medical Res Council | Method |
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AU2001232267A1 (en) | 2000-02-14 | 2001-08-20 | Japan As Represented By Director General Of Agency Of National Institute Of Infectious Deseases | Remedies for hepatitis c |
US20030113316A1 (en) * | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
ATE444308T1 (de) | 2002-02-13 | 2009-10-15 | Ludwig Inst Cancer Res | Fusionsproteine humanisierter g250-spezifischer antikörper sowie verwendungen davon |
ES2311094T3 (es) | 2002-02-27 | 2009-02-01 | Immunex Corporation | Composicion estabilizada de tnfr-fc que comprende arginina. |
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JP4879884B2 (ja) * | 2004-04-12 | 2012-02-22 | メディミューン,エルエルシー | 抗−il−9抗体製剤及びその使用法 |
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CN103342751B (zh) * | 2005-04-18 | 2015-12-23 | 安进研发(慕尼黑)股份有限公司 | 人粒细胞巨噬细胞集落刺激因子的抗体中和剂 |
HUE058876T2 (hu) | 2005-05-18 | 2022-09-28 | Morphosys Ag | Anti-GM-CSF antitestek és felhasználásuk |
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 |
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AU2009243184B2 (en) | 2008-04-28 | 2015-06-04 | Humanigen, Inc. | Antibodies to granulocyte-macrophage colony-stimulating factor |
UA102097C2 (ru) | 2008-04-29 | 2013-06-10 | Амген Рисерч (Мюнхен) ГмбХ | Способ лечения воспалительного заболевания с применением соединения, которое нейтрализует gm-csf, и соединения, которое нейтрализует il-17 |
ES2685895T3 (es) | 2008-12-22 | 2018-10-15 | The University Of Melbourne | Tratamiento del dolor |
WO2010128035A1 (en) | 2009-05-05 | 2010-11-11 | Morphosys Ag | Treatment for multiple sclerosis |
US20120121580A1 (en) * | 2009-07-28 | 2012-05-17 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
CA2783715A1 (en) | 2009-12-29 | 2011-07-07 | F. Hoffmann-La Roche Ag | Novel antibody formulation |
CN107693791B (zh) * | 2010-02-26 | 2022-06-07 | 诺沃—诺迪斯克有限公司 | 包含稳定抗体的组合物 |
EP2399604A1 (en) * | 2010-06-25 | 2011-12-28 | F. Hoffmann-La Roche AG | Novel antibody formulation |
JP2015533806A (ja) | 2012-09-20 | 2015-11-26 | モルフォシス・アー・ゲー | 関節リウマチの治療 |
JP6339578B2 (ja) * | 2012-10-31 | 2018-06-06 | タケダ・ゲー・エム・ベー・ハーTakeda GmbH | Gm−csf中和化合物を含む凍結乾燥製剤 |
-
2013
- 2013-10-30 AR ARP130103964A patent/AR093297A1/es not_active Application Discontinuation
- 2013-10-31 JP JP2015538509A patent/JP6346189B2/ja active Active
- 2013-10-31 EA EA201590509A patent/EA032829B1/ru not_active IP Right Cessation
- 2013-10-31 CN CN201380056759.5A patent/CN104768580B/zh active Active
- 2013-10-31 MX MX2015005237A patent/MX363807B/es active IP Right Grant
- 2013-10-31 TW TW102139662A patent/TWI639440B/zh active
- 2013-10-31 BR BR112015009259A patent/BR112015009259B8/pt active IP Right Grant
- 2013-10-31 EP EP20166154.3A patent/EP3744344A1/en not_active Withdrawn
- 2013-10-31 CA CA2889307A patent/CA2889307C/en active Active
- 2013-10-31 EP EP13798590.9A patent/EP2914290B1/en active Active
- 2013-10-31 WO PCT/EP2013/072761 patent/WO2014068026A1/en active Application Filing
- 2013-10-31 US US14/429,204 patent/US9919051B2/en active Active
- 2013-10-31 KR KR1020157008428A patent/KR102106914B1/ko active IP Right Grant
- 2013-10-31 AU AU2013340845A patent/AU2013340845B2/en active Active
-
2015
- 2015-04-17 PH PH12015500864A patent/PH12015500864A1/en unknown
-
2016
- 2016-03-09 HK HK16102711.6A patent/HK1214761A1/zh unknown
-
2018
- 2018-03-15 US US15/922,777 patent/US10758621B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
MX363807B (es) | 2019-04-03 |
BR112015009259A2 (pt) | 2017-08-22 |
KR20150075083A (ko) | 2015-07-02 |
EP2914290B1 (en) | 2020-04-01 |
WO2014068026A1 (en) | 2014-05-08 |
CN104768580B (zh) | 2018-11-02 |
CA2889307C (en) | 2021-11-23 |
US9919051B2 (en) | 2018-03-20 |
US20180207278A1 (en) | 2018-07-26 |
MX2015005237A (es) | 2015-10-29 |
US10758621B2 (en) | 2020-09-01 |
JP6346189B2 (ja) | 2018-06-20 |
EA201590509A1 (ru) | 2015-10-30 |
TW201438735A (zh) | 2014-10-16 |
PH12015500864B1 (en) | 2015-06-22 |
EA032829B1 (ru) | 2019-07-31 |
JP2015536931A (ja) | 2015-12-24 |
US20150314001A1 (en) | 2015-11-05 |
AR093297A1 (es) | 2015-05-27 |
EP2914290A1 (en) | 2015-09-09 |
CA2889307A1 (en) | 2014-05-08 |
HK1214761A1 (zh) | 2016-08-05 |
BR112015009259B1 (pt) | 2022-05-17 |
TWI639440B (zh) | 2018-11-01 |
AU2013340845B2 (en) | 2018-02-22 |
CN104768580A (zh) | 2015-07-08 |
AU2013340845A1 (en) | 2015-03-26 |
EP3744344A1 (en) | 2020-12-02 |
PH12015500864A1 (en) | 2015-06-22 |
KR102106914B1 (ko) | 2020-05-08 |
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