MX367748B - Formulación de anticuerpo anti her2. - Google Patents
Formulación de anticuerpo anti her2.Info
- Publication number
- MX367748B MX367748B MX2015008194A MX2015008194A MX367748B MX 367748 B MX367748 B MX 367748B MX 2015008194 A MX2015008194 A MX 2015008194A MX 2015008194 A MX2015008194 A MX 2015008194A MX 367748 B MX367748 B MX 367748B
- Authority
- MX
- Mexico
- Prior art keywords
- her2 antibody
- antibody formulation
- anti her2
- lyoprotectant
- antibody
- Prior art date
Links
- 101100314454 Caenorhabditis elegans tra-1 gene Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000008351 acetate buffer Substances 0.000 abstract 1
- 239000004067 bulking agent Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], 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 (2)
| Publication Number | Publication Date |
|---|---|
| MX2015008194A MX2015008194A (es) | 2016-02-05 |
| MX367748B true MX367748B (es) | 2019-09-04 |
Family
ID=49779926
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2015008194A MX367748B (es) | 2012-12-21 | 2013-12-18 | Formulación de anticuerpo anti her2. |
| MX2019010479A MX2019010479A (es) | 2012-12-21 | 2015-06-22 | Formulacion de anticuerpo anti her2. |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019010479A MX2019010479A (es) | 2012-12-21 | 2015-06-22 | Formulacion de anticuerpo anti her2. |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20150343058A1 (enExample) |
| EP (1) | EP2934582B1 (enExample) |
| JP (2) | JP6400595B2 (enExample) |
| AU (1) | AU2013360812B2 (enExample) |
| BR (1) | BR112015014853A2 (enExample) |
| CA (1) | CA2895869C (enExample) |
| DK (1) | DK2934582T3 (enExample) |
| EA (1) | EA201391729A1 (enExample) |
| ES (1) | ES2773103T3 (enExample) |
| IL (1) | IL239509A0 (enExample) |
| MX (2) | MX367748B (enExample) |
| PL (1) | PL2934582T3 (enExample) |
| SG (1) | SG11201504897YA (enExample) |
| WO (1) | WO2014096051A1 (enExample) |
| ZA (1) | ZA201504564B (enExample) |
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 |
| EP3828206A4 (en) * | 2018-07-25 | 2022-04-20 | Daiichi Sankyo Company, Limited | METHOD OF PREPARING AN ANTIBODY DRUG CONJUGATE |
| CN112533958B (zh) | 2018-07-27 | 2024-11-15 | 第一三共株式会社 | 识别抗体-药物缀合物的药物部分的蛋白 |
| JOP20210229A1 (ar) | 2019-02-18 | 2023-01-30 | Lilly Co Eli | صيغة جسم مضاد علاجي |
| SG11202109160UA (en) * | 2019-03-22 | 2021-10-28 | Somalogic Inc | Reducing intersample analyte variability in complex biological matrices |
| IL289219B2 (en) * | 2019-06-28 | 2025-06-01 | Genentech Inc | Composition and methods for stabilizing liquid protein formulations |
| US20220273796A1 (en) * | 2019-07-19 | 2022-09-01 | Ichnos Sciences SA | Lyophilized antibody formulation |
| AU2021228225A1 (en) | 2020-02-28 | 2022-09-01 | Regeneron Pharmaceuticals, Inc. | Bispecific antigen binding molecules that bind HER2, and methods of use thereof |
| CN114504642A (zh) * | 2020-11-17 | 2022-05-17 | 江苏奥赛康药业有限公司 | 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 |
| US20250052742A1 (en) * | 2021-11-12 | 2025-02-13 | Beckman Coulter, Inc. | 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 |
| JP2025513655A (ja) * | 2022-04-22 | 2025-04-25 | エルゲニックス インク | 皮下投与用抗ｈｅｒ２抗体含有医薬組成物 |
| 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 |
|---|---|---|---|---|
| JPH03504605A (ja) * | 1988-05-27 | 1991-10-09 | セントカー・インコーポレーテツド | 抗体産生物の凍結乾燥した配合物 |
| SI2275119T1 (sl) * | 1995-07-27 | 2013-12-31 | Genentech, Inc. | Stabilna izotonična liofilizirana proteinska formulacija |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| CA2292730C (en) * | 1997-06-13 | 2008-09-16 | Genentech, Inc. | Stabilized antibody formulation |
| US7452539B2 (en) * | 2001-12-19 | 2008-11-18 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
| CA2490423A1 (en) * | 2002-06-21 | 2003-12-31 | Biogen Idec Inc. | Buffered formulations for concentrating antibodies and methods of use thereof |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| AU2006255415B2 (en) * | 2005-06-07 | 2011-10-06 | Esbatech, An Alcon Biomedical Research Unit Llc | Stable and soluble antibodies inhibiting TNFalpha |
| CN101217979A (zh) * | 2005-06-14 | 2008-07-09 | 安姆根有限公司 | 自缓冲蛋白制剂 |
| US9345661B2 (en) * | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
-
2013
- 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
- 2013-12-18 MX MX2015008194A patent/MX367748B/es active IP Right Grant
- 2013-12-18 ES ES13808043T patent/ES2773103T3/es active Active
- 2013-12-18 BR BR112015014853A patent/BR112015014853A2/pt not_active Application Discontinuation
- 2013-12-18 PL PL13808043T patent/PL2934582T3/pl unknown
- 2013-12-18 DK DK13808043.7T patent/DK2934582T3/da active
- 2013-12-18 WO PCT/EP2013/077166 patent/WO2014096051A1/en not_active Ceased
- 2013-12-18 SG SG11201504897YA patent/SG11201504897YA/en unknown
- 2013-12-18 CA CA2895869A patent/CA2895869C/en active Active
- 2013-12-18 EP EP13808043.7A patent/EP2934582B1/en active Active
- 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 |
|---|---|
| SG11201504897YA (en) | 2015-07-30 |
| MX2015008194A (es) | 2016-02-05 |
| EA201391729A1 (ru) | 2014-09-30 |
| BR112015014853A2 (pt) | 2017-08-22 |
| US20150343058A1 (en) | 2015-12-03 |
| WO2014096051A1 (en) | 2014-06-26 |
| IL239509A0 (en) | 2015-08-31 |
| PL2934582T3 (pl) | 2020-08-10 |
| AU2013360812B2 (en) | 2018-11-08 |
| DK2934582T3 (da) | 2020-02-24 |
| ES2773103T3 (es) | 2020-07-09 |
| ZA201504564B (en) | 2016-11-30 |
| MX2019010479A (es) | 2019-10-15 |
| WO2014096051A9 (en) | 2014-10-02 |
| JP6400595B2 (ja) | 2018-10-03 |
| CA2895869C (en) | 2020-09-22 |
| JP2016508973A (ja) | 2016-03-24 |
| EP2934582B1 (en) | 2019-11-27 |
| CA2895869A1 (en) | 2014-06-26 |
| HK1215796A1 (en) | 2016-09-15 |
| JP2018199720A (ja) | 2018-12-20 |
| US20200061190A1 (en) | 2020-02-27 |
| AU2013360812A1 (en) | 2015-07-09 |
| EP2934582A1 (en) | 2015-10-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |