DK2934582T3 - Anti-her2-antistofformulering - Google Patents
Anti-her2-antistofformulering Download PDFInfo
- Publication number
- DK2934582T3 DK2934582T3 DK13808043.7T DK13808043T DK2934582T3 DK 2934582 T3 DK2934582 T3 DK 2934582T3 DK 13808043 T DK13808043 T DK 13808043T DK 2934582 T3 DK2934582 T3 DK 2934582T3
- Authority
- DK
- Denmark
- Prior art keywords
- her2 antibody
- antibody formulation
- formulation
- her2
- antibody
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 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)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (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)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (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 |
|---|---|
| DK2934582T3 true DK2934582T3 (da) | 2020-02-24 |
Family
ID=49779926
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13808043.7T DK2934582T3 (da) | 2012-12-21 | 2013-12-18 | Anti-her2-antistofformulering |
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 |
| KR20210038904A (ko) * | 2018-07-25 | 2021-04-08 | 다이이찌 산쿄 가부시키가이샤 | 항체-약물 콘쥬게이트의 효과적인 제조 방법 |
| US12358999B2 (en) | 2018-07-27 | 2025-07-15 | Daiichi Sankyo Company, Limited | Protein recognizing drug moiety of antibody-drug conjugate |
| US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
| CN113508297A (zh) * | 2019-03-22 | 2021-10-15 | 私募蛋白质体公司 | 降低复杂生物基质中样品间分析物的可变性 |
| AU2020304649B2 (en) * | 2019-06-28 | 2025-09-04 | Genentech, Inc. | Composition and methods for stabilizing liquid protein formulations |
| WO2021013689A1 (en) * | 2019-07-19 | 2021-01-28 | Ichnos Sciences SA | Lyophilized antibody formulation |
| CN115175737A (zh) | 2020-02-28 | 2022-10-11 | 瑞泽恩制药公司 | 结合her2的双特异性抗原结合分子及其使用方法 |
| 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 |
| MX2024005772A (es) * | 2021-11-12 | 2024-07-22 | Beckman Coulter Inc | Novedosa formulación para la tinción de anticuerpos conjugados con polímeros. |
| 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 |
| TW202532440A (zh) | 2023-10-19 | 2025-08-16 | 美商建南德克公司 | 用於治療ＨＥＲ２陽性癌症的ＩＬ１５／ＩＬ１５Ｒα異二聚體ＦＣ融合蛋白及ＨＥＲ２ｘＣＤ３雙特異性抗體之組合 |
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. |
| DK2275119T3 (da) * | 1995-07-27 | 2013-11-11 | Genentech Inc | Stabil, isotonisk lyofiliseret proteinformulering |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| EP0999853B1 (en) * | 1997-06-13 | 2003-01-02 | Genentech, Inc. | Stabilized antibody formulation |
| WO2003062375A2 (en) * | 2001-12-19 | 2003-07-31 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
| EP1551875A4 (en) * | 2002-06-21 | 2006-06-28 | Biogen Idec Inc | TAMPON PREPARATIONS FOR CONCENTRATING ANTIBODIES AND METHODS FOR USE THEREOF |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| EP2390267B1 (en) * | 2005-06-07 | 2013-06-05 | ESBATech - a Novartis Company LLC | Stable and soluble antibodies inhibiting TNF(alpha) |
| EP3673919A1 (en) * | 2005-06-14 | 2020-07-01 | Amgen Inc. | Self-buffering protein formulations |
| 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 SG SG11201504897YA patent/SG11201504897YA/en unknown
- 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 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 CA CA2895869A patent/CA2895869C/en active Active
- 2013-12-18 US US14/654,096 patent/US20150343058A1/en not_active Abandoned
- 2013-12-18 PL PL13808043T patent/PL2934582T3/pl unknown
- 2013-12-18 ES ES13808043T patent/ES2773103T3/es active Active
- 2013-12-18 EP EP13808043.7A patent/EP2934582B1/en active Active
- 2013-12-18 JP JP2015548495A patent/JP6400595B2/ja not_active Expired - Fee Related
- 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 |
|---|---|
| MX2015008194A (es) | 2016-02-05 |
| MX2019010479A (es) | 2019-10-15 |
| PL2934582T3 (pl) | 2020-08-10 |
| WO2014096051A9 (en) | 2014-10-02 |
| JP2018199720A (ja) | 2018-12-20 |
| BR112015014853A2 (pt) | 2017-08-22 |
| WO2014096051A1 (en) | 2014-06-26 |
| JP6400595B2 (ja) | 2018-10-03 |
| AU2013360812B2 (en) | 2018-11-08 |
| CA2895869C (en) | 2020-09-22 |
| EA201391729A1 (ru) | 2014-09-30 |
| IL239509A0 (en) | 2015-08-31 |
| ZA201504564B (en) | 2016-11-30 |
| US20200061190A1 (en) | 2020-02-27 |
| EP2934582A1 (en) | 2015-10-28 |
| HK1215796A1 (en) | 2016-09-15 |
| AU2013360812A1 (en) | 2015-07-09 |
| CA2895869A1 (en) | 2014-06-26 |
| MX367748B (es) | 2019-09-04 |
| EP2934582B1 (en) | 2019-11-27 |
| SG11201504897YA (en) | 2015-07-30 |
| JP2016508973A (ja) | 2016-03-24 |
| ES2773103T3 (es) | 2020-07-09 |
| US20150343058A1 (en) | 2015-12-03 |
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