JP2021503485A5 - - Google Patents
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- Publication number
- JP2021503485A5 JP2021503485A5 JP2020527828A JP2020527828A JP2021503485A5 JP 2021503485 A5 JP2021503485 A5 JP 2021503485A5 JP 2020527828 A JP2020527828 A JP 2020527828A JP 2020527828 A JP2020527828 A JP 2020527828A JP 2021503485 A5 JP2021503485 A5 JP 2021503485A5
- Authority
- JP
- Japan
- Prior art keywords
- sugar
- preparation according
- stabilizer
- concentration
- preparation
- 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
- 235000000346 sugar Nutrition 0.000 claims 12
- 239000003381 stabilizer Substances 0.000 claims 6
- 238000009472 formulation Methods 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 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 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 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 2
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims 2
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims 2
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims 2
- 108010081667 aflibercept Proteins 0.000 claims 2
- 229960002833 aflibercept Drugs 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 108020001507 fusion proteins Proteins 0.000 claims 2
- 102000037865 fusion proteins Human genes 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 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-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
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 125000001500 prolyl group Chemical group [H]N1C([H])(C(=O)[*])C([H])([H])C([H])([H])C1([H])[H] 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
- 150000008163 sugars Chemical class 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000012929 tonicity agent Substances 0.000 claims 1
- 125000000647 trehalose group Chemical group 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2024129687A JP2024160287A (ja) | 2017-11-17 | 2024-08-06 | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762587733P | 2017-11-17 | 2017-11-17 | |
| US62/587,733 | 2017-11-17 | ||
| US201862618904P | 2018-01-18 | 2018-01-18 | |
| US62/618,904 | 2018-01-18 | ||
| PCT/US2018/061644 WO2019099921A2 (en) | 2017-11-17 | 2018-11-16 | Vegfr-fc fusion protein formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024129687A Division JP2024160287A (ja) | 2017-11-17 | 2024-08-06 | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2021503485A JP2021503485A (ja) | 2021-02-12 |
| JP2021503485A5 true JP2021503485A5 (enExample) | 2021-12-09 |
| JP7536640B2 JP7536640B2 (ja) | 2024-08-20 |
Family
ID=65041879
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020527828A Active JP7536640B2 (ja) | 2017-11-17 | 2018-11-16 | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
| JP2024129687A Pending JP2024160287A (ja) | 2017-11-17 | 2024-08-06 | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024129687A Pending JP2024160287A (ja) | 2017-11-17 | 2024-08-06 | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US12156900B2 (enExample) |
| EP (1) | EP3709971A2 (enExample) |
| JP (2) | JP7536640B2 (enExample) |
| AU (2) | AU2018368466B2 (enExample) |
| CA (1) | CA3082899A1 (enExample) |
| MA (1) | MA50908A (enExample) |
| MX (2) | MX2020005170A (enExample) |
| WO (1) | WO2019099921A2 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MA50908A (fr) | 2017-11-17 | 2020-09-23 | Amgen Inc | Formulations de protéines de fusion vegfr-fc |
| ES3009668T3 (en) | 2018-01-26 | 2025-03-31 | Univ California | Methods and compositions for treatment of angiogenic disorders using anti-vegf agents |
| US11426446B2 (en) | 2018-03-08 | 2022-08-30 | Coherus Biosciences, Inc. | Stable aqueous formulations of aflibercept |
| WO2019173767A1 (en) * | 2018-03-08 | 2019-09-12 | Coherus Biosciences Inc. | Stable aqueous formulations of aflibercept |
| KR20210021299A (ko) | 2018-05-10 | 2021-02-25 | 리제너론 파아마슈티컬스, 인크. | 고농도 vegf 수용체 융합 단백질 함유 제제 |
| KR20200029374A (ko) * | 2018-09-10 | 2020-03-18 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
| WO2021050687A1 (en) * | 2019-09-10 | 2021-03-18 | Coherus Biosciences, Inc. | Stable aqueous formulations of aflibercept |
| EP4065150A4 (en) | 2019-11-25 | 2023-12-06 | The Regents of the University of California | LONG-ACTING VEGF INHIBITORS FOR INTRAVASCULAR NEOVASCULARIZATION |
| US20230312683A1 (en) * | 2020-07-31 | 2023-10-05 | Celltrion Inc. | Stable pharmaceutical preparation |
| US11723955B1 (en) | 2022-05-13 | 2023-08-15 | Allgenesis Biotherapeutics Inc. | VEGFR fusion protein pharmaceutical composition |
| US12240888B1 (en) | 2024-04-29 | 2025-03-04 | QILU Pharmaceutical, Co., Ltd. | Composition comprising aflibercept and a variant thereof, and related methods and uses |
| WO2025227916A1 (zh) * | 2024-04-29 | 2025-11-06 | 齐鲁制药有限公司 | 包含阿柏西普和其变体的组合物以及相关方法和应用 |
Family Cites Families (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK1478394T3 (da) | 2002-02-27 | 2008-10-13 | Immunex Corp | Stabiliseret TNFR-Fc formulation med arginin |
| DK2335725T3 (en) | 2003-04-04 | 2017-01-23 | Genentech Inc | Highly concentrated antibody and protein formulations |
| AU2006214658A1 (en) | 2005-02-02 | 2006-08-24 | Regeneron Pharmaceuticals, Inc. | Method of treating eye injury with local administration of a VEGF inhibitor |
| CN102614134B (zh) | 2005-03-25 | 2016-09-07 | 瑞泽恩制药公司 | Vegf拮抗剂制剂 |
| WO2006138181A2 (en) | 2005-06-14 | 2006-12-28 | Amgen Inc. | Self-buffering protein formulations |
| US8216575B2 (en) | 2006-03-31 | 2012-07-10 | Chengdu Kanghong Biotechnologies Co., Ltd. | Inhibition of neovascularization with a soluble chimeric protein comprising VEGF FLT-1 and KDR domains |
| RU2432155C3 (ru) | 2006-06-16 | 2017-11-17 | Ридженерон Фармасьютикалз, Инк. | Составы антагониста vegf, подходящие для интравитреального введения |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN103816115B (zh) | 2010-08-31 | 2017-06-27 | 成都康弘生物科技有限公司 | 一种含有抑制血管增生的融合蛋白的药物组合物及用途 |
| PT3574897T (pt) | 2011-11-18 | 2022-04-06 | Regeneron Pharma | Formulação de libertação prolongada compreendendo micropartículas de proteína polimérica para utilização no vítreo do olho para o tratamento de distúrbios oculares vasculares |
| CA2859785A1 (en) | 2011-12-21 | 2013-06-27 | Amgen Inc. | Variant fc-polypeptides with enhanced binding to the neonatal fc receptor |
| CN103212075B (zh) | 2012-01-19 | 2017-06-27 | 成都康弘生物科技有限公司 | 一种含有vegf拮抗剂的滴眼液 |
| KR20150033620A (ko) | 2012-06-01 | 2015-04-01 | 옵쏘테크 코포레이션 | 항-pdgf 압타머 및 vegf 길항제를 포함하는 조성물 |
| US20130323242A1 (en) | 2012-06-01 | 2013-12-05 | Ophthotech Corp. | Compositions comprising an anti-pdgf aptamer and a vegf antagonist |
| UA115789C2 (uk) * | 2012-09-05 | 2017-12-26 | Трейкон Фармасутікалз, Інк. | Композиція антитіла до cd105 та її застосування |
| US9649383B2 (en) | 2012-11-19 | 2017-05-16 | Merck Sharp & Dohme Corp. | Liquid formulations for TNFR:Fc fusion proteins |
| EP3057990B1 (en) | 2013-10-18 | 2019-09-04 | Regeneron Pharmaceuticals, Inc. | Compositions comprising a combination of a vegf antagonist and an anti-ctla-4 antibody |
| CN105435222B (zh) | 2014-09-25 | 2018-05-29 | 信达生物制药(苏州)有限公司 | 重组融合蛋白制剂 |
| KR101808234B1 (ko) | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| CA3001346A1 (en) | 2015-10-16 | 2017-04-20 | Regeneron Pharmaceuticals, Inc. | Stable protein compositions |
| WO2017106716A1 (en) * | 2015-12-16 | 2017-06-22 | Regeneron Pharmaceuticals, Inc. | Compositions and methods of manufacturing protein microparticles |
| EP3407868A1 (en) | 2016-01-26 | 2018-12-05 | Formycon AG | Liquid formulation of a vegf antagonist |
| US20200283472A1 (en) | 2016-03-29 | 2020-09-10 | Navya Biologicals Pvt. Ltd | A process for purification of fc-fusion proteins |
| KR101685532B1 (ko) | 2016-04-26 | 2016-12-13 | 한국프라임제약주식회사 | 혈관내피성장인자 수용체 융합단백질 |
| EP3518971A4 (en) | 2016-09-28 | 2020-05-13 | Board Of Regents, The University Of Texas System | Antibody and protein therapeutic formulations and uses thereof |
| US20180110856A1 (en) | 2016-10-21 | 2018-04-26 | Amgen Inc. | Pharmaceutical Formulations and Methods of Making the Same |
| EP3541365A1 (en) | 2016-11-21 | 2019-09-25 | Just Biotherapeutics, Inc. | Aflibercept formulations and uses thereof |
| DK3559027T3 (da) | 2016-12-23 | 2022-09-05 | Serum Institute Of India Pvt Ltd | Fremgangsmåder til forbedring af antistofoproduktivitet i pattedyrecellekultur og minimering af aggregering nedstrøms, formuleringsprocesser og stabile antistofformuleringer opnået deraf |
| KR101861163B1 (ko) | 2017-04-26 | 2018-05-25 | 삼천당제약주식회사 | 안과용 약학 조성물 |
| WO2019020777A1 (en) | 2017-07-26 | 2019-01-31 | Formycon Ag | LIQUID FORMULATION OF A VEGF ANTAGONIST |
| EP3684332A1 (en) | 2017-09-18 | 2020-07-29 | Amgen Inc. | Vegfr-fc fusion protein formulations |
| CN107595765A (zh) | 2017-09-22 | 2018-01-19 | 沈阳兴齐眼药股份有限公司 | 一种眼用缓释药物递送系统及其制备方法 |
| MA50908A (fr) | 2017-11-17 | 2020-09-23 | Amgen Inc | Formulations de protéines de fusion vegfr-fc |
| CN111356471A (zh) | 2017-11-20 | 2020-06-30 | 济世发展生物药业有限公司 | 包含赖氨酸盐作为张力调节剂的阿柏西普制剂及其用途 |
| WO2019124946A1 (ko) | 2017-12-22 | 2019-06-27 | 삼성바이오에피스 주식회사 | Vegf 길항제를 포함하는 액상 조성물 |
| WO2019173767A1 (en) | 2018-03-08 | 2019-09-12 | Coherus Biosciences Inc. | Stable aqueous formulations of aflibercept |
| US11426446B2 (en) | 2018-03-08 | 2022-08-30 | Coherus Biosciences, Inc. | Stable aqueous formulations of aflibercept |
| KR20210021299A (ko) | 2018-05-10 | 2021-02-25 | 리제너론 파아마슈티컬스, 인크. | 고농도 vegf 수용체 융합 단백질 함유 제제 |
| KR20200029374A (ko) | 2018-09-10 | 2020-03-18 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
| WO2020087003A1 (en) | 2018-10-26 | 2020-04-30 | Amgen Inc. | Formulations comprising a tris buffer and a protein |
| EP3923907B1 (en) | 2019-02-13 | 2024-09-25 | Novaliq GmbH | Compositions and methods for the treatment of ocular neovascularization |
| GB201911461D0 (en) | 2019-08-09 | 2019-09-25 | Arecor Ltd | Novel composition |
| WO2021050687A1 (en) | 2019-09-10 | 2021-03-18 | Coherus Biosciences, Inc. | Stable aqueous formulations of aflibercept |
-
2018
- 2018-11-16 MA MA050908A patent/MA50908A/fr unknown
- 2018-11-16 US US16/764,463 patent/US12156900B2/en active Active
- 2018-11-16 MX MX2020005170A patent/MX2020005170A/es unknown
- 2018-11-16 CA CA3082899A patent/CA3082899A1/en active Pending
- 2018-11-16 JP JP2020527828A patent/JP7536640B2/ja active Active
- 2018-11-16 WO PCT/US2018/061644 patent/WO2019099921A2/en not_active Ceased
- 2018-11-16 AU AU2018368466A patent/AU2018368466B2/en active Active
- 2018-11-16 EP EP18836718.9A patent/EP3709971A2/en active Pending
-
2020
- 2020-07-13 MX MX2025004779A patent/MX2025004779A/es unknown
-
2024
- 2024-07-31 AU AU2024205240A patent/AU2024205240A1/en active Pending
- 2024-08-06 JP JP2024129687A patent/JP2024160287A/ja active Pending
- 2024-11-25 US US18/959,137 patent/US20250082726A1/en active Pending