JP2016505572A5 - - Google Patents
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- Publication number
- JP2016505572A5 JP2016505572A5 JP2015547448A JP2015547448A JP2016505572A5 JP 2016505572 A5 JP2016505572 A5 JP 2016505572A5 JP 2015547448 A JP2015547448 A JP 2015547448A JP 2015547448 A JP2015547448 A JP 2015547448A JP 2016505572 A5 JP2016505572 A5 JP 2016505572A5
- Authority
- JP
- Japan
- Prior art keywords
- solution formulation
- stable solution
- antibody hum13b8
- hum13b8
- antibody
- 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
- 239000000243 solution Substances 0.000 claims 11
- 238000009472 formulation Methods 0.000 claims 10
- 239000000203 mixture Substances 0.000 claims 10
- 229930006000 Sucrose Natural products 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 239000012929 tonicity agent Substances 0.000 claims 3
- 208000023275 Autoimmune disease Diseases 0.000 claims 2
- 208000037979 autoimmune inflammatory disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920001184 polypeptide Polymers 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 102000004196 processed proteins & peptides Human genes 0.000 claims 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims 2
- 230000002062 proliferating effect Effects 0.000 claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 2
- 125000000185 sucrose group Chemical group 0.000 claims 2
- 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 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
- 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
- 201000004681 Psoriasis Diseases 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
- 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 1
- 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 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 239000007951 isotonicity adjuster Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- VREFGVBLTWBCJP-UHFFFAOYSA-N alprazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1 VREFGVBLTWBCJP-UHFFFAOYSA-N 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261737035P | 2012-12-13 | 2012-12-13 | |
| US61/737,035 | 2012-12-13 | ||
| PCT/US2013/073825 WO2014093203A1 (en) | 2012-12-13 | 2013-12-09 | SOLUTION FORMULATIONS OF ENGINEERED ANTI-IL-23p19 ANTIBODIES |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016505572A JP2016505572A (ja) | 2016-02-25 |
| JP2016505572A5 true JP2016505572A5 (enExample) | 2017-12-14 |
| JP6266012B2 JP6266012B2 (ja) | 2018-01-24 |
Family
ID=50934859
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015547448A Active JP6266012B2 (ja) | 2012-12-13 | 2013-12-09 | 改変抗ＩＬ−２３ｐ１９抗体の溶液製剤 |
Country Status (31)
| Country | Link |
|---|---|
| US (3) | US20150329632A1 (enExample) |
| EP (1) | EP2931313B1 (enExample) |
| JP (1) | JP6266012B2 (enExample) |
| KR (1) | KR102004585B1 (enExample) |
| CN (1) | CN104870016B (enExample) |
| AU (1) | AU2013359767B2 (enExample) |
| BR (1) | BR112015013540B1 (enExample) |
| CA (1) | CA2894869C (enExample) |
| CL (1) | CL2015001608A1 (enExample) |
| CY (1) | CY1121895T1 (enExample) |
| DK (1) | DK2931313T3 (enExample) |
| EA (1) | EA034616B1 (enExample) |
| ES (1) | ES2732861T3 (enExample) |
| HR (1) | HRP20191137T1 (enExample) |
| HU (1) | HUE045668T2 (enExample) |
| IL (3) | IL307581A (enExample) |
| LT (1) | LT2931313T (enExample) |
| MX (1) | MX357936B (enExample) |
| MY (1) | MY187921A (enExample) |
| NZ (1) | NZ708443A (enExample) |
| PE (1) | PE20151524A1 (enExample) |
| PH (1) | PH12015501296B1 (enExample) |
| PL (1) | PL2931313T3 (enExample) |
| PT (1) | PT2931313T (enExample) |
| RS (1) | RS59057B1 (enExample) |
| SI (1) | SI2931313T1 (enExample) |
| SM (1) | SMT201900414T1 (enExample) |
| TR (1) | TR201909584T4 (enExample) |
| UA (1) | UA117466C2 (enExample) |
| WO (1) | WO2014093203A1 (enExample) |
| ZA (1) | ZA201504408B (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI761959B (zh) * | 2014-11-07 | 2022-04-21 | 瑞士商諾華公司 | 治療眼部疾病之方法 |
| WO2018181876A1 (ja) * | 2017-03-31 | 2018-10-04 | Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 | 水性製剤及び注射器入り水性製剤、並びに、抗体タンパク脱凝集剤及び抗体タンパク脱凝集方法 |
| JP7516250B2 (ja) | 2018-03-05 | 2024-07-16 | ヤンセン バイオテツク，インコーポレーテツド | 抗ｉｌ－２３特異的抗体を用いたクローン病の治療方法 |
| JP7637618B2 (ja) * | 2018-11-21 | 2025-02-28 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 高濃度タンパク質製剤 |
| AU2019386021B2 (en) | 2018-11-27 | 2024-02-15 | Innovent Biologics (Suzhou) Co., Ltd. | Anti-il-23p19 antibody and uses thereof |
| US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
| EP3928101B1 (en) * | 2019-02-20 | 2024-10-09 | Amgen Inc. | Methods of determining protein stability |
| EP3956357A4 (en) * | 2019-04-15 | 2023-01-04 | Sun Pharmaceutical Industries Limited | METHODS OF TREATMENT OF SUBJECTS WITH PSORIAL ARTHRITIS |
| EP3972690A4 (en) | 2019-05-23 | 2023-07-05 | Janssen Biotech, Inc. | METHOD OF TREATMENT OF INFLAMMATORY BOWEL DISEASE USING COMBINATION THERAPY OF ANTIBODIES TO IL-23 AND TNF-ALPHA |
| TW202535466A (zh) * | 2019-09-09 | 2025-09-16 | 德商百靈佳殷格翰國際股份有限公司 | 抗-il-23p19抗體調配物 |
| CN115135671A (zh) * | 2019-12-20 | 2022-09-30 | 新石生物制药有限公司 | 抗白介素-23 p19的抗体及其使用方法 |
| CA3178853A1 (en) * | 2020-05-13 | 2021-11-18 | Wei Cao | Formulation comprising anti-il-23p19 antibody, method for preparing same and use thereof |
| IL298389A (en) | 2020-05-21 | 2023-01-01 | Janssen Biotech Inc | Method of treating inflammatory bowel disease with a combination therapy of antibodies to il-23 and tnf alpha |
| WO2025071362A1 (ko) * | 2023-09-27 | 2025-04-03 | 삼성바이오에피스 주식회사 | 항-il-23 항체의 안정한 액상 제형 |
Family Cites Families (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1942114A3 (en) | 1999-03-11 | 2008-08-27 | Schering Corporation | Mammalian cytokines; related reagents and methods |
| ATE389019T1 (de) | 1999-09-09 | 2008-03-15 | Schering Corp | Interleukin-12 p40 und interleukin-b30. kombinationen davon. antikörper. verwendungen in pharmazeutische zusammensetzungen |
| US20030113316A1 (en) | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
| EP1441589B1 (en) * | 2001-11-08 | 2012-05-09 | Abbott Biotherapeutics Corp. | Stable liquid pharmaceutical formulation of igg antibodies |
| US7132100B2 (en) | 2002-06-14 | 2006-11-07 | Medimmune, Inc. | Stabilized liquid anti-RSV antibody formulations |
| WO2004071517A2 (en) | 2003-02-06 | 2004-08-26 | Schering Corporation | Uses of il-23 related reagents |
| EP3777880A1 (en) | 2003-02-10 | 2021-02-17 | Biogen MA Inc. | Immunoglobulin formulation and method of preparation thereof |
| TWI357336B (en) | 2003-03-10 | 2012-02-01 | Schering Corp | Uses of il-23 agonists and antagonists; related re |
| WO2004091658A1 (en) * | 2003-04-04 | 2004-10-28 | Genentech, Inc. | High concentration antibody and protein formulations |
| CN1942201B (zh) | 2004-02-17 | 2012-06-20 | 先灵公司 | 调节il-23活性的方法；相关试剂 |
| JP4879884B2 (ja) | 2004-04-12 | 2012-02-22 | メディミューン，エルエルシー | 抗−ｉｌ−９抗体製剤及びその使用法 |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| GT200600031A (es) | 2005-01-28 | 2006-08-29 | Formulacion anticuerpo anti a beta | |
| CA2613818C (en) | 2005-06-30 | 2013-08-27 | Centocor, Inc. | Anti-il-23 antibodies, compositions, methods and uses |
| CA2619052A1 (en) | 2005-08-25 | 2007-03-01 | Eli Lily And Company | Anti-il-23 antibiodies |
| LT1931710T (lt) | 2005-08-31 | 2017-03-27 | Merck Sharp & Dohme Corp. | Rekombinantiniai anti-il-23 antikūnai |
| SI1971366T1 (sl) | 2005-12-29 | 2014-10-30 | Janssen Biotech, Inc. | Humana protitelesa anti-il-23, sestavki, postopki in uporabe |
| EP2044118A2 (en) | 2006-06-13 | 2009-04-08 | Zymogenetics, Inc. | Il-17 and il-23 antagonists and methods of using the same |
| WO2008051363A2 (en) | 2006-10-20 | 2008-05-02 | Amgen Inc. | Stable polypeptide formulations |
| JP5419709B2 (ja) | 2007-01-09 | 2014-02-19 | ワイス・エルエルシー | 抗ｉｌ−１３抗体製剤およびその使用 |
| TWI426918B (zh) | 2007-02-12 | 2014-02-21 | Merck Sharp & Dohme | Ｉｌ-２３拮抗劑於治療感染之用途 |
| RS58098B1 (sr) * | 2007-02-23 | 2019-02-28 | Merck Sharp & Dohme | Anti-il-23p19 antitela proizvedena genetičkim inženjerstvom |
| MX2009009080A (es) | 2007-02-23 | 2009-11-02 | Schering Corp | Anticuerpos anti-interleucina-23p19 manipulados por ingenieria genetica. |
| CA2682292A1 (en) * | 2007-03-30 | 2008-10-09 | Medimmune, Llc | Aqueous formulation comprising an anti-human interferon alpha antibody |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| EP2205276A4 (en) | 2007-09-28 | 2012-08-15 | Janssen Biotech Inc | ANTI-IL-12 / 23P40 ANTIBODIES, EPITOPES, FORMULATIONS, COMPOSITIONS, METHODS AND USES |
| AR068723A1 (es) | 2007-10-05 | 2009-12-02 | Glaxo Group Ltd | Proteina que se une a antigenos que se une a il-23 humana y sus usos |
| PL2234600T3 (pl) | 2007-12-21 | 2015-02-27 | Hoffmann La Roche | Preparat przeciwciała |
| NZ589434A (en) * | 2008-06-03 | 2012-11-30 | Abbott Lab | Dual variable domain immunoglobulins and uses thereof |
| WO2010027766A1 (en) * | 2008-08-27 | 2010-03-11 | Schering Corporation | Lyophilized formulatons of engineered anti-il-23p19 antibodies |
| ES2658596T3 (es) * | 2008-09-19 | 2018-03-12 | Pfizer Inc. | Formulación líquida estable de anticuerpos |
| WO2010062896A1 (en) * | 2008-11-28 | 2010-06-03 | Abbott Laboratories | Stable antibody compositions and methods for stabilizing same |
| US20110158987A1 (en) * | 2009-12-29 | 2011-06-30 | F. Hoffmann-Laroche Ag | Novel antibody formulation |
| PT2691112T (pt) | 2011-03-31 | 2018-07-10 | Merck Sharp & Dohme | Formulações estáveis de anticorpos para o recetor pd-1 humano de morte programada e tratamentos relacionados |
| EP2822591B1 (en) * | 2012-03-07 | 2018-05-02 | Cadila Healthcare Limited | Pharmaceutical formulations of tnf-alpha antibodies |
-
2013
- 2013-09-12 UA UAA201506824A patent/UA117466C2/uk unknown
- 2013-12-09 CA CA2894869A patent/CA2894869C/en active Active
- 2013-12-09 US US14/651,946 patent/US20150329632A1/en active Pending
- 2013-12-09 SI SI201331504T patent/SI2931313T1/sl unknown
- 2013-12-09 PT PT13863590T patent/PT2931313T/pt unknown
- 2013-12-09 HR HRP20191137TT patent/HRP20191137T1/hr unknown
- 2013-12-09 IL IL307581A patent/IL307581A/en unknown
- 2013-12-09 RS RS20190822A patent/RS59057B1/sr unknown
- 2013-12-09 BR BR112015013540-4A patent/BR112015013540B1/pt active IP Right Grant
- 2013-12-09 ES ES13863590T patent/ES2732861T3/es active Active
- 2013-12-09 DK DK13863590.9T patent/DK2931313T3/da active
- 2013-12-09 CN CN201380065606.7A patent/CN104870016B/zh active Active
- 2013-12-09 EA EA201591133A patent/EA034616B1/ru unknown
- 2013-12-09 KR KR1020157018314A patent/KR102004585B1/ko active Active
- 2013-12-09 JP JP2015547448A patent/JP6266012B2/ja active Active
- 2013-12-09 PE PE2015000925A patent/PE20151524A1/es active IP Right Grant
- 2013-12-09 WO PCT/US2013/073825 patent/WO2014093203A1/en not_active Ceased
- 2013-12-09 EP EP13863590.9A patent/EP2931313B1/en active Active
- 2013-12-09 SM SM20190414T patent/SMT201900414T1/it unknown
- 2013-12-09 HU HUE13863590A patent/HUE045668T2/hu unknown
- 2013-12-09 PL PL13863590T patent/PL2931313T3/pl unknown
- 2013-12-09 AU AU2013359767A patent/AU2013359767B2/en active Active
- 2013-12-09 MY MYPI2015701965A patent/MY187921A/en unknown
- 2013-12-09 IL IL278295A patent/IL278295B2/en unknown
- 2013-12-09 LT LTEP13863590.9T patent/LT2931313T/lt unknown
- 2013-12-09 NZ NZ708443A patent/NZ708443A/en unknown
- 2013-12-09 TR TR2019/09584T patent/TR201909584T4/tr unknown
- 2013-12-09 MX MX2015007213A patent/MX357936B/es active IP Right Grant
-
2015
- 2015-06-02 IL IL239150A patent/IL239150B/en active IP Right Grant
- 2015-06-08 PH PH12015501296A patent/PH12015501296B1/en unknown
- 2015-06-10 CL CL2015001608A patent/CL2015001608A1/es unknown
- 2015-06-18 ZA ZA2015/04408A patent/ZA201504408B/en unknown
-
2019
- 2019-06-27 CY CY20191100675T patent/CY1121895T1/el unknown
-
2020
- 2020-12-08 US US17/114,754 patent/US20210188964A1/en active Pending
-
2024
- 2024-01-05 US US18/405,772 patent/US20240239884A1/en active Pending
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