JP2016505572A5 - - Google Patents
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- 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
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- 102000004965 antibodies Human genes 0.000 claims description 8
- 108090001123 antibodies Proteins 0.000 claims description 8
- 239000000243 solution Substances 0.000 claims 11
- 238000009472 formulation Methods 0.000 claims 10
- 239000000203 mixture Substances 0.000 claims 10
- CZMRCDWAGMRECN-GDQSFJPYSA-N Sucrose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1)[C@@]1(CO)[C@H](O)[C@@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-GDQSFJPYSA-N 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 206010003816 Autoimmune disease Diseases 0.000 claims 2
- 229940068968 Polysorbate 80 Drugs 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 200000000018 inflammatory disease Diseases 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
- 230000002062 proliferating Effects 0.000 claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 2
- 125000000185 sucrose group Chemical group 0.000 claims 2
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N D-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
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N 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
- 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
- 201000009596 autoimmune hypersensitivity disease Diseases 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
- 201000004681 psoriasis Diseases 0.000 claims 1
- 230000037396 body weight Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 231100000486 side effect Toxicity 0.000 description 1
- 230000003442 weekly Effects 0.000 description 1
Description
抗体は、連続注入により、または例えば１日、週に１〜７回、１週間、２週間、月１回、２ヶ月に１回、年４回、半年に１回または年１回の間隔での投与により提供することができる。好ましい投与プロトコルは、重大な望ましくない副作用を回避する最大用量または投与頻度を含むものである。合計週用量は、一般に少なくとも０．０５μｇ／ｋｇ、０．２μｇ／ｋｇ、０．５μｇ／ｋｇ、１μｇ／ｋｇ、１０μｇ／ｋｇ、１００μｇ／ｋｇ、０．２ｍｇ／ｋｇ、１．０ｍｇ／ｋｇ、２．０ｍｇ／ｋｇ、１０ｍｇ／ｋｇ、２５ｍｇ／ｋｇ、５０ｍｇ／ｋｇ体重であり、またはこれを超える。例えば、Ｙａｎｇら（２００３）Ｎｅｗ Ｅｎｇｌ．Ｊ．Ｍｅｄ．３４９；４２７〜４３４頁；Ｈｅｒｏｌｄら（２００２）Ｎｅｗ Ｅｎｇｌ．Ｊ．Ｍｅｄ．３４６；１６９２〜１６９８頁；Ｌｉｕら（１９９９）Ｊ．Ｎｅｕｒｏｌ．Ｎｅｕｒｏｓｕｒｇ．Ｐｓｙｃｈ．６７；４５１〜４５６頁；Ｐｏｒｔｉｅｌｊｉら（２０００３）Ｃａｎｃｅｒ Ｉｍｍｕｎｏｌ．Ｉｍｍｕｎｏｔｈｅｒ．５２；１３３〜１４４頁参照。
Claims (11)
- ａ）少なくとも５０ｍｇ／ｍｌ抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂと、
ｂ）ｐＨ５．５〜６．０のヒスチジン緩衝液と、
ｃ）界面活性剤と、
ｄ）溶液を等張にするために必要な量の等張化剤であって、スクロース、トレハロース又はマンニトールである等張化剤と
を含み、
前記抗体ｈｕｍ１３Ｂ８−ｂが、
ｉ）配列番号２の配列を含む軽鎖ポリペプチドと、
ｉｉ）配列番号１の配列を含む重鎖ポリペプチドと
を含む、抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂの安定な溶液製剤。 - 少なくとも８０ｍｇ／ｍｌ抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂを含む、請求項１に記載の安定な溶液製剤。
- 少なくとも１００ｍｇ／ｍｌ抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂを含む、請求項２に記載の安定な溶液製剤。
- ８０〜１２０ｍｇ／ｍｌ抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂを含む、請求項１に記載の安定な溶液製剤。
- 約１００ｍｇ／ｍｌ抗ＩＬ−２３ｐ１９抗体ｈｕｍ１３Ｂ８−ｂを含む、請求項４に記載の安定な溶液製剤。
- 自己免疫疾患、炎症性疾患、または増殖性障害の治療において使用するための、請求項１〜５のいずれかに記載の安定な溶液製剤。
- 年４回の皮下投与を含む乾癬を治療する方法に用いる医薬品の製造における、請求項４に記載の安定な溶液製剤の使用。
- 皮下投与がシリンジ、自動注射器、注射器ペンまたは無針注射装置を用いる注射により行われる、請求項７に記載の使用。
- 界面活性剤がポリソルベート８０であり、等張化剤がスクロースである、請求項１に記載の安定な溶液製剤。
- 界面活性剤が０〜０．０５％（Ｗ／Ｖ）のポリソルベート８０であり、等張化剤が７％（Ｗ／Ｖ）スクロースである、請求項９の安定な溶液製剤。
- 自己免疫疾患、炎症性疾患、または増殖性障害を治療するための医薬品の製造における、請求項１〜５のいずれかに記載の安定な溶液製剤の使用。
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 (ja) | 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 (ja) |
| EP (1) | EP2931313B1 (ja) |
| JP (1) | JP6266012B2 (ja) |
| KR (1) | KR102004585B1 (ja) |
| CN (1) | CN104870016B (ja) |
| AU (1) | AU2013359767B2 (ja) |
| BR (1) | BR112015013540B1 (ja) |
| CA (1) | CA2894869C (ja) |
| CL (1) | CL2015001608A1 (ja) |
| CY (1) | CY1121895T1 (ja) |
| DK (1) | DK2931313T3 (ja) |
| EA (1) | EA034616B1 (ja) |
| ES (1) | ES2732861T3 (ja) |
| HK (1) | HK1215194A1 (ja) |
| HR (1) | HRP20191137T1 (ja) |
| HU (1) | HUE045668T2 (ja) |
| IL (3) | IL307581A (ja) |
| LT (1) | LT2931313T (ja) |
| MX (1) | MX357936B (ja) |
| MY (1) | MY187921A (ja) |
| NZ (1) | NZ708443A (ja) |
| PE (1) | PE20151524A1 (ja) |
| PH (1) | PH12015501296A1 (ja) |
| PL (1) | PL2931313T3 (ja) |
| PT (1) | PT2931313T (ja) |
| RS (1) | RS59057B1 (ja) |
| SI (1) | SI2931313T1 (ja) |
| TR (1) | TR201909584T4 (ja) |
| UA (1) | UA117466C2 (ja) |
| WO (1) | WO2014093203A1 (ja) |
| ZA (1) | ZA201504408B (ja) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI705827B (zh) | 2014-11-07 | 2020-10-01 | 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 |
| IL276896B2 (en) * | 2018-03-05 | 2024-06-01 | Janssen Biotech Inc | Methods for treating Crohn's disease with a specific anti-IL23 antibody |
| KR20210093976A (ko) | 2018-11-21 | 2021-07-28 | 리제너론 파아마슈티컬스, 인크. | 고농도 단백질 제형 |
| US11634485B2 (en) | 2019-02-18 | 2023-04-25 | Eli Lilly And Company | Therapeutic antibody formulation |
| WO2020172293A1 (en) * | 2019-02-20 | 2020-08-27 | Amgen Inc. | Methods of determining protein stability |
| JP2022534020A (ja) | 2019-05-23 | 2022-07-27 | ヤンセン バイオテツク，インコーポレーテツド | Ｉｌ－２３及びｔｎｆアルファに対する抗体の併用療法による炎症性腸疾患の治療方法 |
| US20210070852A1 (en) * | 2019-09-09 | 2021-03-11 | Boehringer Ingelheim International Gmbh | Anti-IL-23p19 Antibody Formulations |
| KR20220143005A (ko) | 2019-12-20 | 2022-10-24 | 노바록 바이오테라퓨틱스 리미티드 | 항-인터루킨-23 p19 항체 및 이의 사용 방법 |
| JP2023525825A (ja) * | 2020-05-13 | 2023-06-19 | イノベント バイオロジクス（スーチョウ）カンパニー，リミティド | 抗ＩＬ－２３ｐ１９抗体を含む製剤、その調製方法および使用 |
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| ATE420894T1 (de) | 1999-03-11 | 2009-01-15 | Schering Corp | Cytokine aus säugetieren, verwandte reagenzien und verfahren |
| CA2388562C (en) | 1999-09-09 | 2014-07-22 | Schering Corporation | Mammalian cytokines; related reagents and methods |
| MXPA04000747A (es) | 2001-07-25 | 2004-07-08 | Protein Desing Labs Inc | Formulacion farmaceutica liofilizada estable de anticuerpos igg. |
| KR100913714B1 (ko) * | 2001-11-08 | 2009-08-24 | 패시트 바이오테크 코포레이션 | Ｉｇｇ 항체의 안정한 액상 약학 제형물 |
| US7132100B2 (en) | 2002-06-14 | 2006-11-07 | Medimmune, Inc. | Stabilized liquid anti-RSV antibody formulations |
| US20040219150A1 (en) | 2003-02-06 | 2004-11-04 | Cua Daniel J. | Uses of mammalian cytokine; related reagents |
| SI3417875T1 (sl) | 2003-02-10 | 2021-01-29 | Biogen Ma Inc. | Formulacija imunoglobulina in metode za njegovo pripravo |
| ES2330220T3 (es) | 2003-03-10 | 2009-12-07 | Schering Corporation | Usos de antagonistas de il-23; reactivos relacionados. |
| AU2004229335C1 (en) * | 2003-04-04 | 2010-06-17 | Genentech, Inc. | High concentration antibody and protein formulations |
| NZ548897A (en) | 2004-02-17 | 2009-07-31 | Schering Corp | Methods of modulating IL-23 activity; related reagents |
| US7691379B2 (en) | 2004-04-12 | 2010-04-06 | Medimmune, Llc | Anti-IL-9 antibody formulations |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
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| EA013506B1 (ru) | 2005-08-25 | 2010-06-30 | Эли Лилли Энд Компани | Антитело к il-23 и его применение |
| ME02705B (me) | 2005-08-31 | 2017-10-20 | Merck Sharp & Dohme | Inženjerisana anti-il-23 antitela |
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-
2013
- 2013-09-12 UA UAA201506824A patent/UA117466C2/uk unknown
- 2013-12-09 HU HUE13863590A patent/HUE045668T2/hu unknown
- 2013-12-09 IL IL307581A patent/IL307581A/en unknown
- 2013-12-09 IL IL278295A patent/IL278295B2/en unknown
- 2013-12-09 PT PT13863590T patent/PT2931313T/pt unknown
- 2013-12-09 CN CN201380065606.7A patent/CN104870016B/zh active Active
- 2013-12-09 EA EA201591133A patent/EA034616B1/ru unknown
- 2013-12-09 BR BR112015013540-4A patent/BR112015013540B1/pt active IP Right Grant
- 2013-12-09 LT LTEP13863590.9T patent/LT2931313T/lt unknown
- 2013-12-09 EP EP13863590.9A patent/EP2931313B1/en active Active
- 2013-12-09 RS RS20190822A patent/RS59057B1/sr unknown
- 2013-12-09 CA CA2894869A patent/CA2894869C/en active Active
- 2013-12-09 PL PL13863590T patent/PL2931313T3/pl unknown
- 2013-12-09 US US14/651,946 patent/US20150329632A1/en active Pending
- 2013-12-09 AU AU2013359767A patent/AU2013359767B2/en active Active
- 2013-12-09 ES ES13863590T patent/ES2732861T3/es active Active
- 2013-12-09 MX MX2015007213A patent/MX357936B/es active IP Right Grant
- 2013-12-09 PE PE2015000925A patent/PE20151524A1/es active IP Right Grant
- 2013-12-09 TR TR2019/09584T patent/TR201909584T4/tr unknown
- 2013-12-09 SI SI201331504T patent/SI2931313T1/sl unknown
- 2013-12-09 KR KR1020157018314A patent/KR102004585B1/ko active IP Right Grant
- 2013-12-09 MY MYPI2015701965A patent/MY187921A/en unknown
- 2013-12-09 JP JP2015547448A patent/JP6266012B2/ja active Active
- 2013-12-09 NZ NZ708443A patent/NZ708443A/en unknown
- 2013-12-09 DK DK13863590.9T patent/DK2931313T3/da active
- 2013-12-09 WO PCT/US2013/073825 patent/WO2014093203A1/en active Application Filing
-
2015
- 2015-06-02 IL IL239150A patent/IL239150B/en active IP Right Grant
- 2015-06-08 PH PH12015501296A patent/PH12015501296A1/en unknown
- 2015-06-10 CL CL2015001608A patent/CL2015001608A1/es unknown
- 2015-06-18 ZA ZA2015/04408A patent/ZA201504408B/en unknown
-
2016
- 2016-03-22 HK HK16103299.4A patent/HK1215194A1/zh unknown
-
2019
- 2019-06-21 HR HRP20191137TT patent/HRP20191137T1/hr unknown
- 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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