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 (cg-RX-API-DMAC7.html) | 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)
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT3378535T (pt) | 2011-10-28 | 2023-02-06 | Prothena Biosciences Ltd | Anticorpos humanizados que reconhecem a alfa-sinucleína |
| WO2013112945A1 (en) | 2012-01-27 | 2013-08-01 | Neotope Biosciences Limited | 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 |
| EP3129051A1 (en) | 2014-04-08 | 2017-02-15 | Prothena Biosciences Limited | Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein |
| GB201512203D0 (en) | 2015-07-13 | 2015-08-19 | Lundbeck & Co As H | Agents,uses and methods |
| WO2017027861A1 (en) | 2015-08-13 | 2017-02-16 | Amgen Inc. | Charged depth filtration of antigen-binding proteins |
| 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 |
| CN115998859A (zh) * | 2016-06-27 | 2023-04-25 | 莫佛塞斯公司 | 抗-cd19抗体制剂 |
| MA46836A (fr) | 2016-11-15 | 2019-09-25 | H Lundbeck As | Agents, utilisations et procédés pour le traitement d'une synucléinopathie |
| 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 |
| EP3583124A1 (en) | 2017-02-17 | 2019-12-25 | Bristol-Myers Squibb Company | Antibodies to alpha-synuclein and uses thereof |
| CA3076313A1 (en) * | 2017-09-28 | 2019-04-04 | Prothena Biosciences Limited | Dosing regimes for treatment of synucleinopathies |
| 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 |
| 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 |
| MA55033A (fr) | 2019-02-18 | 2021-12-29 | Lilly Co Eli | Formulation d'anticorps thérapeutique |
| 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 |
| UY39337A (es) | 2020-07-23 | 2022-02-25 | Othair Prothena Ltd | Anticuerpos anti-abeta |
| MX2023002851A (es) | 2020-09-10 | 2023-03-22 | Prothena Biosciences Ltd | Tratamiento de la enfermedad de parkinson. |
| 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 |
| CN117915952A (zh) | 2021-09-16 | 2024-04-19 | H.隆德贝克有限公司 | 用于治疗突触核蛋白病的组合物和方法 |
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-
2014
- 2014-07-02 US US14/322,797 patent/US10513555B2/en active Active
- 2014-07-03 AU AU2014285719A patent/AU2014285719A1/en not_active Abandoned
- 2014-07-03 WO PCT/IB2014/062806 patent/WO2015001504A2/en not_active Ceased
- 2014-07-03 CN CN201480047476.9A patent/CN105492019B/zh active Active
- 2014-07-03 JP JP2016522950A patent/JP6404338B2/ja active Active
- 2014-07-03 CU CUP2017000039A patent/CU20170039A7/es unknown
- 2014-07-03 MX MX2016000201A patent/MX2016000201A/es unknown
- 2014-07-03 PE PE2015002708A patent/PE20160868A1/es not_active Application Discontinuation
- 2014-07-03 SG SG11201510601TA patent/SG11201510601TA/en unknown
- 2014-07-03 KR KR1020167003163A patent/KR20160030247A/ko not_active Withdrawn
- 2014-07-03 RU RU2016103079A patent/RU2016103079A/ru not_active Application Discontinuation
- 2014-07-03 CA CA2917097A patent/CA2917097C/en active Active
- 2014-07-03 EP EP14752412.8A patent/EP3016677B1/en active Active
- 2014-07-03 EP EP18212531.0A patent/EP3524264A1/en active Pending
- 2014-07-03 ES ES14752412T patent/ES2704440T3/es active Active
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2015
- 2015-12-16 PH PH12015502788A patent/PH12015502788A1/en unknown
- 2015-12-31 IL IL243425A patent/IL243425A0/en unknown
- 2015-12-31 CL CL2015003801A patent/CL2015003801A1/es 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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