JP2013079270A5 - - Google Patents
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- JP2013079270A5 JP2013079270A5 JP2012282406A JP2012282406A JP2013079270A5 JP 2013079270 A5 JP2013079270 A5 JP 2013079270A5 JP 2012282406 A JP2012282406 A JP 2012282406A JP 2012282406 A JP2012282406 A JP 2012282406A JP 2013079270 A5 JP2013079270 A5 JP 2013079270A5
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- Prior art keywords
- fusion protein
- formulation
- vegf
- histidine
- glycine
- Prior art date
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Claims (11)
- (i)SEQ ID NO：4の27〜457位のアミノ酸配列を含む融合タンパク質である血管内皮増殖因子(VEGF)特異的融合タンパク質アンタゴニスト、(ii)緩衝液、(iii)有機共溶媒または充填剤、および(iv)1つまたは複数のリオプロテクタント（lyoprotectant)を含む、凍結乾燥前の製剤。
- 緩衝液がヒスチジンである、請求項１記載の凍結乾燥前の製剤。
- 有機共溶媒または充填剤がPEGである、請求項１または２記載の凍結乾燥前の製剤。
- リオプロテクタントがグリシンおよびスクロースの少なくとも一方である、請求項１乃至３のいずれか一項記載の凍結乾燥前の製剤。
- pH約6.0〜6.5で、5〜50 mMヒスチジン、0.1〜3.0％PEG、0.25〜3.0％グリシン、0.5〜6.0％スクロース、および 5〜75 mg/mlの融合タンパク質を含む、請求項１記載の凍結乾燥前の製剤。
- pH約6.25で、約10 mMヒスチジン、約1.5％PEG 3350、約0.75％グリシン、約2.5％スクロース、および約12.5〜75 mg/ml 該融合タンパク質を含む、請求項５記載の凍結乾燥前の製剤。
- 融合タンパク質が50 mg/mlである、請求項６記載の凍結乾燥前の製剤。
- 請求項７記載の凍結乾燥前の製剤を凍結乾燥に供し、凍結乾燥製剤を生成する段階を含む、VEGF特異的融合タンパク質アンタゴニストの凍結乾燥製剤の製造方法。
- 請求項８記載の凍結乾燥製剤を液体で再組成する段階を含み、再組成した凍結乾燥製剤が生成される、VEGF特異的融合タンパク質アンタゴニストの再組成した凍結乾燥製剤の製造方法。
- 液体が滅菌水または静菌水である、請求項９記載の方法。
- pH 6.3で、100 mg/mlのSEQ ID NO：4の27〜457位のアミノ酸配列を含む融合タンパク質である血管内皮増殖因子(VEGF)特異的融合タンパク質アンタゴニスト、20 mMヒスチジン、3.0％ PEG、1.5％グリシン、及び5.0％スクロースを含む、再組成した凍結乾燥製剤。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US66512505P | 2005-03-25 | 2005-03-25 | |
| US60/665,125 | 2005-03-25 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008503191A Division JP5376573B2 (ja) | 2005-03-25 | 2006-03-22 | Ｖｅｇｆアンタゴニスト製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013079270A JP2013079270A (ja) | 2013-05-02 |
| JP2013079270A5 true JP2013079270A5 (ja) | 2013-11-14 |
| JP5752671B2 JP5752671B2 (ja) | 2015-07-22 |
Family
ID=36678320
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008503191A Active JP5376573B2 (ja) | 2005-03-25 | 2006-03-22 | Ｖｅｇｆアンタゴニスト製剤 |
| JP2012282406A Active JP5752671B2 (ja) | 2005-03-25 | 2012-12-26 | Ｖｅｇｆアンタゴニスト製剤 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008503191A Active JP5376573B2 (ja) | 2005-03-25 | 2006-03-22 | Ｖｅｇｆアンタゴニスト製剤 |
Country Status (20)
| Country | Link |
|---|---|
| US (16) | US20060217311A1 (ja) |
| EP (3) | EP1861116B1 (ja) |
| JP (2) | JP5376573B2 (ja) |
| KR (1) | KR101327270B1 (ja) |
| CN (2) | CN101141975B (ja) |
| AU (1) | AU2006229930C1 (ja) |
| CA (3) | CA2598711C (ja) |
| CY (2) | CY1116980T1 (ja) |
| DK (2) | DK2586459T3 (ja) |
| ES (2) | ES2548238T3 (ja) |
| HK (1) | HK1116050A1 (ja) |
| HU (2) | HUE027096T2 (ja) |
| IL (2) | IL185606A (ja) |
| LT (1) | LT2586459T (ja) |
| NZ (1) | NZ560713A (ja) |
| PL (2) | PL1861116T3 (ja) |
| PT (2) | PT2586459T (ja) |
| SI (2) | SI1861116T1 (ja) |
| WO (1) | WO2006104852A2 (ja) |
| ZA (1) | ZA200708845B (ja) |
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| CN107115294B (zh) | 2012-01-19 | 2019-10-18 | 北京康弘生物医药有限公司 | 一种含有vegf拮抗剂的滴眼液 |
| JOP20200175A1 (ar) | 2012-07-03 | 2017-06-16 | Novartis Ag | حقنة |
| RU2634406C1 (ru) | 2014-01-25 | 2017-10-26 | Чэнду Канхун Байотекнолоджиз Ко., Лтд. | Слитый белок, ингибирующий ангиогенез или рост сосудов, и его применение |
| US20160144025A1 (en) | 2014-11-25 | 2016-05-26 | Regeneron Pharmaceuticals, Inc. | Methods and formulations for treating vascular eye diseases |
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