JP2019512540A5 - - Google Patents
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- Publication number
- JP2019512540A5 JP2019512540A5 JP2018566642A JP2018566642A JP2019512540A5 JP 2019512540 A5 JP2019512540 A5 JP 2019512540A5 JP 2018566642 A JP2018566642 A JP 2018566642A JP 2018566642 A JP2018566642 A JP 2018566642A JP 2019512540 A5 JP2019512540 A5 JP 2019512540A5
- Authority
- JP
- Japan
- Prior art keywords
- cyclodextrin
- seq
- antibody
- sequence defined
- liquid
- 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
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- 229920000858 Cyclodextrin Polymers 0.000 claims 16
- 239000007788 liquid Substances 0.000 claims 12
- 239000012669 liquid formulation Substances 0.000 claims 9
- 238000002360 preparation method Methods 0.000 claims 9
- 239000001116 FEMA 4028 Substances 0.000 claims 6
- 239000000427 antigen Substances 0.000 claims 6
- 102000036639 antigens Human genes 0.000 claims 6
- 108091007433 antigens Proteins 0.000 claims 6
- 229960004853 betadex Drugs 0.000 claims 6
- 239000012634 fragment Substances 0.000 claims 6
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims 6
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 4
- 229940080345 gamma-cyclodextrin Drugs 0.000 claims 4
- 229930182817 methionine Natural products 0.000 claims 4
- JVFGXECLSQXABC-UHFFFAOYSA-N ac1l3obq Chemical compound O1C(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(O)C2O)C(COCC(O)C)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC2C(O)C(O)C1OC2COCC(C)O JVFGXECLSQXABC-UHFFFAOYSA-N 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 208000020084 Bone disease Diseases 0.000 claims 2
- 208000029725 Metabolic bone disease Diseases 0.000 claims 2
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 2
- 210000000988 bone and bone Anatomy 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 2
- PCWPQSDFNIFUPO-VDQKLNDWSA-N (1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31S,33R,35R,36R,37S,38R,39S,40R,41S,42R,43S,44R,45S,46R,47S,48R,49S)-37,39,41,43,45,47,49-heptakis(2-hydroxyethoxy)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,38,40,42,44,46,48-heptol Chemical compound OCCO[C@H]1[C@H](O)[C@@H]2O[C@H]3O[C@H](CO)[C@@H](O[C@H]4O[C@H](CO)[C@@H](O[C@H]5O[C@H](CO)[C@@H](O[C@H]6O[C@H](CO)[C@@H](O[C@H]7O[C@H](CO)[C@@H](O[C@H]8O[C@H](CO)[C@@H](O[C@H]1O[C@@H]2CO)[C@@H](O)[C@@H]8OCCO)[C@@H](O)[C@@H]7OCCO)[C@@H](O)[C@@H]6OCCO)[C@@H](O)[C@@H]5OCCO)[C@@H](O)[C@@H]4OCCO)[C@@H](O)[C@@H]3OCCO PCWPQSDFNIFUPO-VDQKLNDWSA-N 0.000 claims 1
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 claims 1
- 101000711796 Homo sapiens Sclerostin Proteins 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- 208000001132 Osteoporosis Diseases 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 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 1
- 239000004480 active ingredient Substances 0.000 claims 1
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 claims 1
- 229940043377 alpha-cyclodextrin Drugs 0.000 claims 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 1
- 230000037118 bone strength Effects 0.000 claims 1
- VSGNNIFQASZAOI-UHFFFAOYSA-L calcium acetate Chemical compound [Ca+2].CC([O-])=O.CC([O-])=O VSGNNIFQASZAOI-UHFFFAOYSA-L 0.000 claims 1
- 239000001639 calcium acetate Substances 0.000 claims 1
- 229960005147 calcium acetate Drugs 0.000 claims 1
- 235000011092 calcium acetate Nutrition 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 claims 1
- 102000058171 human SOST Human genes 0.000 claims 1
- 239000000017 hydrogel Substances 0.000 claims 1
- -1 hydroxypropyl Chemical group 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 230000011164 ossification Effects 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 238000001556 precipitation Methods 0.000 claims 1
- 239000001632 sodium acetate Substances 0.000 claims 1
- 235000017281 sodium acetate Nutrition 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 1
- DSDAICPXUXPBCC-MWDJDSKUSA-N trimethyl-β-cyclodextrin Chemical compound COC[C@H]([C@H]([C@@H]([C@H]1OC)OC)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O[C@H]3O[C@H](COC)[C@H]([C@@H]([C@H]3OC)OC)O3)[C@H](OC)[C@H]2OC)COC)O[C@@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@@H]3O[C@@H]1COC DSDAICPXUXPBCC-MWDJDSKUSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022001395A JP2022062014A (ja) | 2016-03-10 | 2022-01-07 | 医薬製剤 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1604124.6A GB201604124D0 (en) | 2016-03-10 | 2016-03-10 | Pharmaceutical formulation |
| GB1604124.6 | 2016-03-10 | ||
| PCT/EP2017/055594 WO2017153541A1 (en) | 2016-03-10 | 2017-03-09 | Pharmaceutical formulation |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022001395A Division JP2022062014A (ja) | 2016-03-10 | 2022-01-07 | 医薬製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019512540A JP2019512540A (ja) | 2019-05-16 |
| JP2019512540A5 true JP2019512540A5 (https=) | 2020-04-09 |
| JP7539761B2 JP7539761B2 (ja) | 2024-08-26 |
Family
ID=55952141
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018566642A Active JP7539761B2 (ja) | 2016-03-10 | 2017-03-09 | 医薬製剤 |
| JP2022001395A Pending JP2022062014A (ja) | 2016-03-10 | 2022-01-07 | 医薬製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022001395A Pending JP2022062014A (ja) | 2016-03-10 | 2022-01-07 | 医薬製剤 |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US11576970B2 (https=) |
| EP (2) | EP4226915A1 (https=) |
| JP (2) | JP7539761B2 (https=) |
| CN (2) | CN108883175A (https=) |
| CA (1) | CA3016117A1 (https=) |
| DK (1) | DK3426294T3 (https=) |
| ES (1) | ES2946259T3 (https=) |
| FI (1) | FI3426294T3 (https=) |
| GB (1) | GB201604124D0 (https=) |
| HR (1) | HRP20230733T1 (https=) |
| HU (1) | HUE062429T2 (https=) |
| LT (1) | LT3426294T (https=) |
| MA (1) | MA43705A (https=) |
| PL (1) | PL3426294T3 (https=) |
| PT (1) | PT3426294T (https=) |
| RS (1) | RS64337B1 (https=) |
| SI (1) | SI3426294T1 (https=) |
| SM (1) | SMT202300183T1 (https=) |
| WO (1) | WO2017153541A1 (https=) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10961305B2 (en) | 2016-12-21 | 2021-03-30 | Mereo Biopharma 3 Limited | Use of anti-sclerostin antibodies in the treatment of osteogenesis imperfecta |
| CN109952093B (zh) * | 2017-07-27 | 2022-02-08 | 江苏恒瑞医药股份有限公司 | 一种sost抗体药物组合物及其用途 |
| EP3774879B1 (en) | 2018-03-30 | 2026-01-28 | Amgen Inc. | C-terminal antibody variants |
| MA53272A (fr) * | 2018-08-10 | 2021-11-17 | Amgen Inc | Procédé de préparation d'une formulation pharmaceutique d'anticorps |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| EP4013786A1 (en) * | 2019-08-12 | 2022-06-22 | Amgen Inc. | Anti-sclerostin antibody formulations |
| EP4434517A4 (en) * | 2021-11-30 | 2025-06-25 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Anti-sost antibody pharmaceutical composition and use thereof |
| WO2023224112A1 (ja) * | 2022-05-20 | 2023-11-23 | 株式会社ダイセル | 液状医薬組成物 |
| CN118236484B (zh) * | 2022-12-23 | 2025-11-04 | 信立泰(苏州)药业有限公司 | 一种Romosozumab抗体稳定制剂及其制备方法和用途 |
| WO2024259656A1 (en) * | 2023-06-21 | 2024-12-26 | Shanghai Mabgeek Biotech Co., Ltd. | Formulation of an anti-il-4 receptor alpha mab or an antigen-binding fragment thereof comprising 2hpbetacd and leucine |
| AR133302A1 (es) * | 2023-07-19 | 2025-09-17 | Amgen Inc | Métodos de preparación de amortiguador para una formulación de proteína terapéutica |
| CN118384184A (zh) * | 2024-04-25 | 2024-07-26 | 北京圣美细胞生命科学工程研究院有限公司 | 一种经修饰的免疫细胞外泌体组合物及其制备方法 |
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