JP2016534052A5 - - Google Patents
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- JP2016534052A5 JP2016534052A5 JP2016522950A JP2016522950A JP2016534052A5 JP 2016534052 A5 JP2016534052 A5 JP 2016534052A5 JP 2016522950 A JP2016522950 A JP 2016522950A JP 2016522950 A JP2016522950 A JP 2016522950A JP 2016534052 A5 JP2016534052 A5 JP 2016534052A5
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- JP
- Japan
- Prior art keywords
- antibody
- concentration
- seq
- present
- amino acid
- 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.)
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- 125000003275 alpha amino acid group Chemical group 0.000 claims 11
- 229920001213 Polysorbate 20 Polymers 0.000 claims 8
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 8
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 8
- 229940068977 polysorbate 20 Drugs 0.000 claims 8
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 6
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 239000007790 solid phase Substances 0.000 claims 6
- 229940074410 trehalose Drugs 0.000 claims 6
- 238000009472 formulation Methods 0.000 claims 5
- 238000002360 preparation method Methods 0.000 claims 5
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 4
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 4
- 239000004472 Lysine Substances 0.000 claims 4
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 4
- 210000004899 c-terminal region Anatomy 0.000 claims 4
- 229960002303 citric acid monohydrate Drugs 0.000 claims 4
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 239000007979 citrate buffer Substances 0.000 claims 3
- 239000012535 impurity Substances 0.000 claims 3
- 102000004169 proteins and genes Human genes 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- 238000003860 storage Methods 0.000 claims 3
- DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims 2
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 2
- 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 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 238000004587 chromatography analysis Methods 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 229920005862 polyol Polymers 0.000 claims 2
- 150000003077 polyols Chemical class 0.000 claims 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 2
- 229960000999 sodium citrate dihydrate Drugs 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 235000000346 sugar Nutrition 0.000 claims 2
- -1 trehalose anhydride Chemical class 0.000 claims 2
- 229940074409 trehalose dihydrate Drugs 0.000 claims 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- 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
- 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 102000019355 Synuclein Human genes 0.000 claims 1
- 108050006783 Synuclein Proteins 0.000 claims 1
- 241000700605 Viruses Species 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 238000005349 anion exchange Methods 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 238000005341 cation exchange Methods 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 238000002270 exclusion chromatography Methods 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 230000002779 inactivation Effects 0.000 claims 1
- 239000012931 lyophilized formulation 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
- 238000000034 method Methods 0.000 claims 1
- 230000003204 osmotic effect Effects 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000008223 sterile water Substances 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- 150000008163 sugars Chemical class 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361843011P | 2013-07-04 | 2013-07-04 | |
| US61/843,011 | 2013-07-04 | ||
| US201461979886P | 2014-04-15 | 2014-04-15 | |
| US61/979,886 | 2014-04-15 | ||
| PCT/IB2014/062806 WO2015001504A2 (en) | 2013-07-04 | 2014-07-03 | Antibody formulations and methods |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018170393A Division JP6854266B2 (ja) | 2013-07-04 | 2018-09-12 | 抗体製剤および方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016534052A JP2016534052A (ja) | 2016-11-04 |
| JP2016534052A5 true JP2016534052A5 (https=) | 2017-08-10 |
| JP6404338B2 JP6404338B2 (ja) | 2018-10-10 |
Family
ID=51355583
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016522950A Active JP6404338B2 (ja) | 2013-07-04 | 2014-07-03 | 抗体製剤および方法 |
| JP2018170393A Active JP6854266B2 (ja) | 2013-07-04 | 2018-09-12 | 抗体製剤および方法 |
| JP2020177954A Pending JP2021020941A (ja) | 2013-07-04 | 2020-10-23 | 抗体製剤および方法 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018170393A Active JP6854266B2 (ja) | 2013-07-04 | 2018-09-12 | 抗体製剤および方法 |
| JP2020177954A Pending JP2021020941A (ja) | 2013-07-04 | 2020-10-23 | 抗体製剤および方法 |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US10513555B2 (https=) |
| EP (2) | EP3016677B1 (https=) |
| JP (3) | JP6404338B2 (https=) |
| KR (1) | KR20160030247A (https=) |
| CN (1) | CN105492019B (https=) |
| AU (1) | AU2014285719A1 (https=) |
| CA (1) | CA2917097C (https=) |
| CL (1) | CL2015003801A1 (https=) |
| CU (2) | CU20170039A7 (https=) |
| ES (1) | ES2704440T3 (https=) |
| IL (1) | IL243425A0 (https=) |
| MX (1) | MX2016000201A (https=) |
| PE (1) | PE20160868A1 (https=) |
| PH (1) | PH12015502788A1 (https=) |
| RU (1) | RU2016103079A (https=) |
| SG (1) | SG11201510601TA (https=) |
| WO (1) | WO2015001504A2 (https=) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8609820B2 (en) | 2011-10-28 | 2013-12-17 | Neotope Biosciences Limited | Humanized antibodies that recognize alpha-synuclein |
| NZ629296A (en) | 2012-01-27 | 2016-06-24 | Prothena Biosciences Ltd | Humanized antibodies that recognize alpha-synuclein |
| UA118441C2 (uk) | 2012-10-08 | 2019-01-25 | Протена Біосаєнсиз Лімітед | Антитіло, що розпізнає альфа-синуклеїн |
| US10513555B2 (en) | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| JP6744856B2 (ja) | 2014-04-08 | 2020-08-19 | プロセナ・バイオサイエンシズ・リミテッド | α−シヌクレインを認識する抗体を含む血液脳関門シャトル |
| GB201512203D0 (en) | 2015-07-13 | 2015-08-19 | Lundbeck & Co As H | Agents,uses and methods |
| LT4209499T (lt) | 2015-08-13 | 2024-11-25 | Amgen Inc. | Antigeną surišančių baltymų įkrautas giluminis filtravimas |
| CA2999079A1 (en) * | 2015-09-28 | 2017-04-06 | Jiangsu Hengrui Medicine Co., Ltd. | Stable anti-pd-1 antibody pharmaceutical preparation and application thereof in medicine |
| CN105127166A (zh) * | 2015-09-29 | 2015-12-09 | 中国华能集团清洁能源技术研究院有限公司 | 行走组件及具有其的光伏组件清洁装置 |
| SI3475303T1 (sl) * | 2016-06-27 | 2021-12-31 | Morphosys Ag | Formulacija protitelesa proti CD19 |
| AR110074A1 (es) | 2016-11-15 | 2019-02-20 | H Lundbeck As | Agentes, usos y métodos para el tratamiento de la sinucleinopatía |
| CN110072888B (zh) | 2016-12-16 | 2023-07-18 | H.隆德贝克有限公司 | 药剂、用途和方法 |
| US10364286B2 (en) | 2016-12-22 | 2019-07-30 | H. Lundbeck A/S | Monoclonal anti-alpha-synuclein antibodies for preventing tau aggregation |
| CN110506057B (zh) | 2017-02-17 | 2023-09-29 | 百时美施贵宝公司 | Alpha突触核蛋白抗体及其应用 |
| JP2021502955A (ja) * | 2017-09-28 | 2021-02-04 | プロセナ・バイオサイエンシズ・リミテッド | シヌクレイン病の治療のための投与レジメン |
| US20190153102A1 (en) * | 2017-09-28 | 2019-05-23 | Prothena Biosciences Limited | Dosing regimes for treatment of synucleinopathies |
| GB201720970D0 (en) | 2017-12-15 | 2018-01-31 | Ucb Biopharma Sprl | Antibodies |
| GB201720975D0 (en) | 2017-12-15 | 2018-01-31 | Ucb Biopharma Sprl | Anti-alpha synuclein antibodies |
| JP6831861B2 (ja) | 2019-01-25 | 2021-02-17 | 株式会社Ｇｒｉｎ | 歯科用測定器具、測定方法、及びアタッチメント器具 |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| EP3786174A1 (en) * | 2019-08-27 | 2021-03-03 | Ichnos Sciences SA | Methods for antibody purification |
| GB2587228B (en) * | 2019-09-20 | 2021-10-27 | Protein Ark Ltd | Biological sample purification apparatus, use of the same, and systems comprising the same |
| MX2023000949A (es) | 2020-07-23 | 2023-02-22 | Othair Prothena Ltd | Anticuerpos anti-beta-amiloide (abeta). |
| IL301039A (en) | 2020-09-10 | 2023-05-01 | Prothena Biosciences Ltd | Treatment of parkinson's disease |
| CN114516914B (zh) * | 2020-11-19 | 2023-04-28 | 东莞市朋志生物科技有限公司 | 抗n末端脑钠肽前体的抗体和检测n末端脑钠肽前体的试剂和试剂盒 |
| KR20240055758A (ko) * | 2021-09-16 | 2024-04-29 | 하. 룬드벡 아크티에셀스카브 | 시누클레인병증을 치료하기 위한 조성물 및 방법 |
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| RU2665810C2 (ru) | 2011-10-31 | 2018-09-04 | Дженентек, Инк. | Содержащие антитела составы |
| NZ629296A (en) | 2012-01-27 | 2016-06-24 | Prothena Biosciences Ltd | Humanized antibodies that recognize alpha-synuclein |
| US9216219B2 (en) * | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| RU2711552C2 (ru) | 2012-08-29 | 2020-01-17 | Ф. Хоффманн-Ля Рош Аг | Шаттл для гематоэнцефалического барьера |
| US8925815B2 (en) | 2012-09-05 | 2015-01-06 | Symbol Technologies, Inc. | Checkout system for and method of preventing a customer-operated accessory reader facing a bagging area from imaging targets on products passed through a clerk-operated workstation to the bagging area |
| UA118441C2 (uk) | 2012-10-08 | 2019-01-25 | Протена Біосаєнсиз Лімітед | Антитіло, що розпізнає альфа-синуклеїн |
| US10513555B2 (en) | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| JP6744856B2 (ja) | 2014-04-08 | 2020-08-19 | プロセナ・バイオサイエンシズ・リミテッド | α−シヌクレインを認識する抗体を含む血液脳関門シャトル |
| US10084674B2 (en) | 2015-09-09 | 2018-09-25 | International Business Machines Corporation | Virtual desktop operation and data continuity preservation |
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2014
- 2014-07-02 US US14/322,797 patent/US10513555B2/en active Active
- 2014-07-03 SG SG11201510601TA patent/SG11201510601TA/en unknown
- 2014-07-03 KR KR1020167003163A patent/KR20160030247A/ko not_active Withdrawn
- 2014-07-03 WO PCT/IB2014/062806 patent/WO2015001504A2/en not_active Ceased
- 2014-07-03 EP EP14752412.8A patent/EP3016677B1/en active Active
- 2014-07-03 CA CA2917097A patent/CA2917097C/en active Active
- 2014-07-03 JP JP2016522950A patent/JP6404338B2/ja active Active
- 2014-07-03 RU RU2016103079A patent/RU2016103079A/ru not_active Application Discontinuation
- 2014-07-03 AU AU2014285719A patent/AU2014285719A1/en not_active Abandoned
- 2014-07-03 CN CN201480047476.9A patent/CN105492019B/zh active Active
- 2014-07-03 MX MX2016000201A patent/MX2016000201A/es unknown
- 2014-07-03 CU CUP2017000039A patent/CU20170039A7/es unknown
- 2014-07-03 EP EP18212531.0A patent/EP3524264A1/en active Pending
- 2014-07-03 ES ES14752412T patent/ES2704440T3/es active Active
- 2014-07-03 PE PE2015002708A patent/PE20160868A1/es not_active Application Discontinuation
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2015
- 2015-12-16 PH PH12015502788A patent/PH12015502788A1/en unknown
- 2015-12-31 CL CL2015003801A patent/CL2015003801A1/es unknown
- 2015-12-31 IL IL243425A patent/IL243425A0/en unknown
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2016
- 2016-01-04 CU CUP2016000001A patent/CU20160001A7/es unknown
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2018
- 2018-09-12 JP JP2018170393A patent/JP6854266B2/ja active Active
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2019
- 2019-11-01 US US16/672,330 patent/US20200140534A1/en not_active Abandoned
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2020
- 2020-10-23 JP JP2020177954A patent/JP2021020941A/ja active Pending
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