BR112015014853A2 - Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura - Google Patents
Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufaturaInfo
- Publication number
- BR112015014853A2 BR112015014853A2 BR112015014853A BR112015014853A BR112015014853A2 BR 112015014853 A2 BR112015014853 A2 BR 112015014853A2 BR 112015014853 A BR112015014853 A BR 112015014853A BR 112015014853 A BR112015014853 A BR 112015014853A BR 112015014853 A2 BR112015014853 A2 BR 112015014853A2
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical formulation
- article
- manufacture
- lyophilized
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Oncology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261745293P | 2012-12-21 | 2012-12-21 | |
| PCT/EP2013/077166 WO2014096051A1 (en) | 2012-12-21 | 2013-12-18 | Anti her2 antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112015014853A2 true BR112015014853A2 (pt) | 2017-08-22 |
Family
ID=49779926
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112015014853A BR112015014853A2 (pt) | 2012-12-21 | 2013-12-18 | Formulação farmacêutica, formulação farmacêutica liofilizada, uso de uma formulação farmacêutica e artigo de manufatura |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20150343058A1 (https=) |
| EP (1) | EP2934582B1 (https=) |
| JP (2) | JP6400595B2 (https=) |
| AU (1) | AU2013360812B2 (https=) |
| BR (1) | BR112015014853A2 (https=) |
| CA (1) | CA2895869C (https=) |
| DK (1) | DK2934582T3 (https=) |
| EA (1) | EA201391729A1 (https=) |
| ES (1) | ES2773103T3 (https=) |
| IL (1) | IL239509A0 (https=) |
| MX (2) | MX367748B (https=) |
| PL (1) | PL2934582T3 (https=) |
| SG (1) | SG11201504897YA (https=) |
| WO (1) | WO2014096051A1 (https=) |
| ZA (1) | ZA201504564B (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| KR101776879B1 (ko) | 2015-01-19 | 2017-09-08 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
| GB2542391A (en) * | 2015-09-17 | 2017-03-22 | Annexin Pharmaceuticals Ab | Process of manufacture |
| SG11202100653YA (en) * | 2018-07-25 | 2021-02-25 | Daiichi Sankyo Co Ltd | Effective method for manufacturing antibody-drug conjugate |
| WO2020022475A1 (ja) | 2018-07-27 | 2020-01-30 | 第一三共株式会社 | 抗体－薬物コンジュゲートの薬物部位を認識する蛋白質 |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| SG11202109160UA (en) * | 2019-03-22 | 2021-10-28 | Somalogic Inc | Reducing intersample analyte variability in complex biological matrices |
| JP2022538293A (ja) * | 2019-06-28 | 2022-09-01 | ジェネンテック， インコーポレイテッド | 液体タンパク質製剤を安定化するための組成物及び方法 |
| US20220273796A1 (en) * | 2019-07-19 | 2022-09-01 | Ichnos Sciences SA | Lyophilized antibody formulation |
| KR20220148200A (ko) | 2020-02-28 | 2022-11-04 | 리제너론 파마슈티칼스 인코포레이티드 | Her2에 결합하는 이중특이적 항원 결합 분자 및 이의 사용 방법 |
| CN114504642B (zh) * | 2020-11-17 | 2026-03-27 | 江苏奥赛康生物医药有限公司 | 一种含抗cldn18.2抗体的液体药物组合物 |
| CN114762727A (zh) * | 2021-01-15 | 2022-07-19 | 海正生物制药有限公司 | 一种稳定的帕妥珠单抗的药物组合物 |
| CA3237877A1 (en) * | 2021-11-12 | 2023-05-19 | Aditya JARARE | Novel formulation for drying of polymer dye conjugated antibodies |
| WO2023140807A1 (en) * | 2022-01-19 | 2023-07-27 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical compositions of trastuzumab |
| TWI864690B (zh) * | 2022-04-22 | 2024-12-01 | 台康生技股份有限公司 | 用於皮下投予之包含抗-her2抗體的藥學組合物 |
| WO2025085781A1 (en) | 2023-10-19 | 2025-04-24 | Genentech, Inc. | Combinations of il15/il15r alpha heterodimeric fc-fusion proteins and her2xcd3 bispecific antibodies for the treatment of her2-positive cancers |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE68908175T2 (de) * | 1988-05-27 | 1994-03-03 | Centocor Inc | Gefriergetrocknete formulierung für antikörperprodukte. |
| ES2434840T3 (es) * | 1995-07-27 | 2013-12-17 | Genentech, Inc. | Formulación de proteína liofilizada isotónica estable |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| CA2635352C (en) * | 1997-06-13 | 2012-09-11 | Genentech, Inc. | Stabilized antibody formulation |
| US7452539B2 (en) * | 2001-12-19 | 2008-11-18 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
| CN1671741A (zh) * | 2002-06-21 | 2005-09-21 | 拜奥根Idec公司 | 浓缩抗体的缓冲剂制剂及其使用方法 |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| KR101457223B1 (ko) * | 2005-06-07 | 2014-11-04 | 에스바테크 - 어 노바티스 컴파니 엘엘씨 | ＴＮＦα를 억제하는 안정적이고 가용성인 항체 |
| BRPI0611901A2 (pt) * | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| US9345661B2 (en) * | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
-
2013
- 2013-12-18 DK DK13808043.7T patent/DK2934582T3/da active
- 2013-12-18 MX MX2015008194A patent/MX367748B/es active IP Right Grant
- 2013-12-18 CA CA2895869A patent/CA2895869C/en active Active
- 2013-12-18 SG SG11201504897YA patent/SG11201504897YA/en unknown
- 2013-12-18 ES ES13808043T patent/ES2773103T3/es active Active
- 2013-12-18 PL PL13808043T patent/PL2934582T3/pl unknown
- 2013-12-18 EP EP13808043.7A patent/EP2934582B1/en active Active
- 2013-12-18 WO PCT/EP2013/077166 patent/WO2014096051A1/en not_active Ceased
- 2013-12-18 BR BR112015014853A patent/BR112015014853A2/pt not_active Application Discontinuation
- 2013-12-18 US US14/654,096 patent/US20150343058A1/en not_active Abandoned
- 2013-12-18 JP JP2015548495A patent/JP6400595B2/ja not_active Expired - Fee Related
- 2013-12-18 AU AU2013360812A patent/AU2013360812B2/en not_active Ceased
- 2013-12-19 EA EA201391729A patent/EA201391729A1/ru unknown
-
2015
- 2015-06-18 IL IL239509A patent/IL239509A0/en unknown
- 2015-06-22 MX MX2019010479A patent/MX2019010479A/es unknown
- 2015-06-24 ZA ZA2015/04564A patent/ZA201504564B/en unknown
-
2018
- 2018-09-05 JP JP2018165536A patent/JP2018199720A/ja active Pending
-
2019
- 2019-07-08 US US16/504,411 patent/US20200061190A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| JP6400595B2 (ja) | 2018-10-03 |
| WO2014096051A1 (en) | 2014-06-26 |
| US20200061190A1 (en) | 2020-02-27 |
| IL239509A0 (en) | 2015-08-31 |
| WO2014096051A9 (en) | 2014-10-02 |
| AU2013360812A1 (en) | 2015-07-09 |
| MX2019010479A (es) | 2019-10-15 |
| PL2934582T3 (pl) | 2020-08-10 |
| DK2934582T3 (da) | 2020-02-24 |
| ZA201504564B (en) | 2016-11-30 |
| SG11201504897YA (en) | 2015-07-30 |
| CA2895869A1 (en) | 2014-06-26 |
| CA2895869C (en) | 2020-09-22 |
| JP2016508973A (ja) | 2016-03-24 |
| AU2013360812B2 (en) | 2018-11-08 |
| HK1215796A1 (en) | 2016-09-15 |
| MX2015008194A (es) | 2016-02-05 |
| EP2934582A1 (en) | 2015-10-28 |
| EP2934582B1 (en) | 2019-11-27 |
| US20150343058A1 (en) | 2015-12-03 |
| EA201391729A1 (ru) | 2014-09-30 |
| MX367748B (es) | 2019-09-04 |
| ES2773103T3 (es) | 2020-07-09 |
| JP2018199720A (ja) | 2018-12-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06I | Publication of requirement cancelled [chapter 6.9 patent gazette] |
Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B25D | Requested change of name of applicant approved |
Owner name: ICHNOS SCIENCES SA (CH) |
|
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B11B | Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements |