JP2016508973A5 - - Google Patents
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- Publication number
- JP2016508973A5 JP2016508973A5 JP2015548495A JP2015548495A JP2016508973A5 JP 2016508973 A5 JP2016508973 A5 JP 2016508973A5 JP 2015548495 A JP2015548495 A JP 2015548495A JP 2015548495 A JP2015548495 A JP 2015548495A JP 2016508973 A5 JP2016508973 A5 JP 2016508973A5
- Authority
- JP
- Japan
- Prior art keywords
- her2
- pharmaceutical
- pharmaceutical formulation
- preparation
- formulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 9
- 239000000825 pharmaceutical preparation Substances 0.000 claims 9
- 229930006000 Sucrose Natural products 0.000 claims 6
- 239000005720 sucrose Substances 0.000 claims 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Natural products NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 5
- 239000012634 fragment Substances 0.000 claims 5
- 102000051957 human ERBB2 Human genes 0.000 claims 5
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 4
- 239000004471 Glycine Substances 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 3
- 238000009472 formulation Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000007974 sodium acetate buffer Substances 0.000 claims 3
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 2
- 208000026310 Breast neoplasm Diseases 0.000 claims 2
- 206010063916 Metastatic gastric cancer Diseases 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 239000008351 acetate buffer Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000012931 lyophilized formulation Substances 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 239000002738 chelating agent Substances 0.000 claims 1
- 239000003638 chemical reducing agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- -1 lyoprotectants Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261745293P | 2012-12-21 | 2012-12-21 | |
| US61/745,293 | 2012-12-21 | ||
| PCT/EP2013/077166 WO2014096051A1 (en) | 2012-12-21 | 2013-12-18 | Anti her2 antibody formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018165536A Division JP2018199720A (ja) | 2012-12-21 | 2018-09-05 | 抗ｈｅｒ２抗体製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016508973A JP2016508973A (ja) | 2016-03-24 |
| JP2016508973A5 true JP2016508973A5 (cg-RX-API-DMAC7.html) | 2017-01-19 |
| JP6400595B2 JP6400595B2 (ja) | 2018-10-03 |
Family
ID=49779926
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015548495A Expired - Fee Related JP6400595B2 (ja) | 2012-12-21 | 2013-12-18 | 抗ｈｅｒ２抗体製剤 |
| JP2018165536A Pending JP2018199720A (ja) | 2012-12-21 | 2018-09-05 | 抗ｈｅｒ２抗体製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018165536A Pending JP2018199720A (ja) | 2012-12-21 | 2018-09-05 | 抗ｈｅｒ２抗体製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20150343058A1 (cg-RX-API-DMAC7.html) |
| EP (1) | EP2934582B1 (cg-RX-API-DMAC7.html) |
| JP (2) | JP6400595B2 (cg-RX-API-DMAC7.html) |
| AU (1) | AU2013360812B2 (cg-RX-API-DMAC7.html) |
| BR (1) | BR112015014853A2 (cg-RX-API-DMAC7.html) |
| CA (1) | CA2895869C (cg-RX-API-DMAC7.html) |
| DK (1) | DK2934582T3 (cg-RX-API-DMAC7.html) |
| EA (1) | EA201391729A1 (cg-RX-API-DMAC7.html) |
| ES (1) | ES2773103T3 (cg-RX-API-DMAC7.html) |
| IL (1) | IL239509A0 (cg-RX-API-DMAC7.html) |
| MX (2) | MX367748B (cg-RX-API-DMAC7.html) |
| PL (1) | PL2934582T3 (cg-RX-API-DMAC7.html) |
| SG (1) | SG11201504897YA (cg-RX-API-DMAC7.html) |
| WO (1) | WO2014096051A1 (cg-RX-API-DMAC7.html) |
| ZA (1) | ZA201504564B (cg-RX-API-DMAC7.html) |
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 |
| WO2020022363A1 (ja) * | 2018-07-25 | 2020-01-30 | 第一三共株式会社 | 抗体－薬物コンジュゲートの効果的な製造方法 |
| TWI846717B (zh) | 2018-07-27 | 2024-07-01 | 日商第一三共股份有限公司 | 辨識抗體-藥物結合物之藥物部位的蛋白質 |
| MA55033A (fr) | 2019-02-18 | 2021-12-29 | Lilly Co Eli | Formulation d'anticorps thérapeutique |
| SG11202109160UA (en) * | 2019-03-22 | 2021-10-28 | Somalogic Inc | Reducing intersample analyte variability in complex biological matrices |
| CN114040754A (zh) * | 2019-06-28 | 2022-02-11 | 基因泰克公司 | 用于稳定液体蛋白质制剂的组合物及方法 |
| US20220273796A1 (en) * | 2019-07-19 | 2022-09-01 | Ichnos Sciences SA | Lyophilized antibody formulation |
| WO2021174113A1 (en) | 2020-02-28 | 2021-09-02 | 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 |
| AU2021473587A1 (en) * | 2021-11-12 | 2024-06-20 | 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 |
| EP4511062A1 (en) * | 2022-04-22 | 2025-02-26 | Eirgenix, Inc. | Pharmaceutical compositons containing anti-her2 antibody for subcutaneous administration |
| 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 |
|---|---|---|---|---|
| WO1989011297A1 (en) * | 1988-05-27 | 1989-11-30 | Centocor, Inc. | Freeze-dried formulation for antibody products |
| DK1516628T3 (da) * | 1995-07-27 | 2013-09-08 | 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 |
| US7452539B2 (en) * | 2001-12-19 | 2008-11-18 | Genentech, Inc. | Stabilizing polypeptides which have been exposed to urea |
| WO2004001007A2 (en) * | 2002-06-21 | 2003-12-31 | Idec Pharmaceuticals Corporation | Buffered formulations for concentrating antibodies and methods of use thereof |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| PL2390267T3 (pl) * | 2005-06-07 | 2013-09-30 | Esbatech A Novartis Co Llc | Stabilne i rozpuszczalne przeciwciała hamujące TNF(alfa) |
| EP3351269B1 (en) * | 2005-06-14 | 2020-01-29 | 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 SG SG11201504897YA patent/SG11201504897YA/en unknown
- 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 MX MX2015008194A patent/MX367748B/es active IP Right Grant
- 2013-12-18 EP EP13808043.7A patent/EP2934582B1/en active Active
- 2013-12-18 US US14/654,096 patent/US20150343058A1/en not_active Abandoned
- 2013-12-18 AU AU2013360812A patent/AU2013360812B2/en not_active Ceased
- 2013-12-18 CA CA2895869A patent/CA2895869C/en active Active
- 2013-12-18 JP JP2015548495A patent/JP6400595B2/ja not_active Expired - Fee Related
- 2013-12-18 DK DK13808043.7T patent/DK2934582T3/da active
- 2013-12-18 PL PL13808043T patent/PL2934582T3/pl unknown
- 2013-12-18 ES ES13808043T patent/ES2773103T3/es 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