JPWO2022076562A5 - - Google Patents
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- Publication number
- JPWO2022076562A5 JPWO2022076562A5 JP2023521060A JP2023521060A JPWO2022076562A5 JP WO2022076562 A5 JPWO2022076562 A5 JP WO2022076562A5 JP 2023521060 A JP2023521060 A JP 2023521060A JP 2023521060 A JP2023521060 A JP 2023521060A JP WO2022076562 A5 JPWO2022076562 A5 JP WO2022076562A5
- Authority
- JP
- Japan
- Prior art keywords
- lyophilized composition
- mrna
- aqueous solution
- integrity
- lipid
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 claims 17
- 108020004999 messenger RNA Proteins 0.000 claims 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 9
- 150000002632 lipids Chemical class 0.000 claims 9
- 238000000034 method Methods 0.000 claims 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 8
- 239000007864 aqueous solution Substances 0.000 claims 7
- 239000002105 nanoparticle Substances 0.000 claims 5
- 229960005070 ascorbic acid Drugs 0.000 claims 4
- 235000010323 ascorbic acid Nutrition 0.000 claims 4
- 239000011668 ascorbic acid Substances 0.000 claims 4
- 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
- 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
- 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 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- MWRBNPKJOOWZPW-GPADLTIESA-N 1,2-di-[(9E)-octadecenoyl]-sn-glycero-3-phosphoethanolamine Chemical compound CCCCCCCC\C=C\CCCCCCCC(=O)OC[C@H](COP(O)(=O)OCCN)OC(=O)CCCCCCC\C=C\CCCCCCCC MWRBNPKJOOWZPW-GPADLTIESA-N 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 1
- -1 cationic lipid Chemical class 0.000 claims 1
- 235000012000 cholesterol Nutrition 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 230000008014 freezing Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063088047P | 2020-10-06 | 2020-10-06 | |
| US63/088,047 | 2020-10-06 | ||
| PCT/US2021/053776 WO2022076562A1 (en) | 2020-10-06 | 2021-10-06 | Improved process and formulation of lipid nanoparticles |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2023544197A JP2023544197A (ja) | 2023-10-20 |
| JP2023544197A5 JP2023544197A5 (https=) | 2024-10-15 |
| JPWO2022076562A5 true JPWO2022076562A5 (https=) | 2024-10-15 |
Family
ID=78500735
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023521060A Pending JP2023544197A (ja) | 2020-10-06 | 2021-10-06 | 脂質ナノ粒子の改善された方法および製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20230372440A1 (https=) |
| EP (1) | EP4225268A1 (https=) |
| JP (1) | JP2023544197A (https=) |
| KR (1) | KR20230083323A (https=) |
| CN (1) | CN116546976A (https=) |
| AU (1) | AU2021358777A1 (https=) |
| CA (1) | CA3194863A1 (https=) |
| WO (1) | WO2022076562A1 (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017020026A1 (en) | 2015-07-30 | 2017-02-02 | Modernatx, Inc. | Concatemeric peptide epitopes rnas |
| TW201729835A (zh) | 2015-10-22 | 2017-09-01 | 現代公司 | 呼吸道病毒疫苗 |
| WO2018089851A2 (en) | 2016-11-11 | 2018-05-17 | Modernatx, Inc. | Influenza vaccine |
| WO2018170245A1 (en) | 2017-03-15 | 2018-09-20 | Modernatx, Inc. | Broad spectrum influenza virus vaccine |
| WO2018187590A1 (en) | 2017-04-05 | 2018-10-11 | Modernatx, Inc. | Reduction or elimination of immune responses to non-intravenous, e.g., subcutaneously administered therapeutic proteins |
| WO2019148101A1 (en) | 2018-01-29 | 2019-08-01 | Modernatx, Inc. | Rsv rna vaccines |
| AU2021376893A1 (en) * | 2020-11-16 | 2023-06-15 | BioNTech SE | Enhanced formulation stabilization and improved lyophilization processes |
| US12329811B2 (en) | 2021-01-11 | 2025-06-17 | Modernatx, Inc. | Seasonal RNA influenza virus vaccines |
| WO2022232585A1 (en) * | 2021-04-29 | 2022-11-03 | Modernatx, Inc. | Lyophilization methods for preparing lipid formulated therapeutics |
| CN114557971B (zh) * | 2022-04-25 | 2023-05-23 | 康希诺生物股份公司 | 一种核酸-脂质纳米颗粒的冷冻干燥保护剂及其制备方法和应用 |
| WO2023212696A1 (en) * | 2022-04-29 | 2023-11-02 | Modernatx, Inc. | Lyophilized human cytomegalovirus vaccines |
| CN115624630A (zh) * | 2022-12-19 | 2023-01-20 | 北京荷牧生物科技有限公司 | 冻干保护组合物及其应用和基于该组合物的核酸脂质纳米颗粒冻存方法 |
| WO2024160936A1 (en) | 2023-02-03 | 2024-08-08 | Glaxosmithkline Biologicals Sa | Rna formulation |
| EP4701658A1 (en) | 2023-04-27 | 2026-03-04 | GlaxoSmithKline Biologicals S.A. | Influenza virus vaccines |
| WO2024223724A1 (en) | 2023-04-27 | 2024-10-31 | Glaxosmithkline Biologicals Sa | Influenza virus vaccines |
| WO2025029323A1 (en) * | 2023-07-28 | 2025-02-06 | Vitrivax, Inc. | Compositions, methods, and uses for polynucleotide formulations for drying and prolonged storage |
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| US4458066A (en) | 1980-02-29 | 1984-07-03 | University Patents, Inc. | Process for preparing polynucleotides |
| US4500707A (en) | 1980-02-29 | 1985-02-19 | University Patents, Inc. | Nucleosides useful in the preparation of polynucleotides |
| US5132418A (en) | 1980-02-29 | 1992-07-21 | University Patents, Inc. | Process for preparing polynucleotides |
| US4415732A (en) | 1981-03-27 | 1983-11-15 | University Patents, Inc. | Phosphoramidite compounds and processes |
| US4973679A (en) | 1981-03-27 | 1990-11-27 | University Patents, Inc. | Process for oligonucleo tide synthesis using phosphormidite intermediates |
| US4668777A (en) | 1981-03-27 | 1987-05-26 | University Patents, Inc. | Phosphoramidite nucleoside compounds |
| US4401796A (en) | 1981-04-30 | 1983-08-30 | City Of Hope Research Institute | Solid-phase synthesis of polynucleotides |
| US4373071A (en) | 1981-04-30 | 1983-02-08 | City Of Hope Research Institute | Solid-phase synthesis of polynucleotides |
| US4897355A (en) | 1985-01-07 | 1990-01-30 | Syntex (U.S.A.) Inc. | N[ω,(ω-1)-dialkyloxy]- and N-[ω,(ω-1)-dialkenyloxy]-alk-1-yl-N,N,N-tetrasubstituted ammonium lipids and uses therefor |
| US5153319A (en) | 1986-03-31 | 1992-10-06 | University Patents, Inc. | Process for preparing polynucleotides |
| US5262530A (en) | 1988-12-21 | 1993-11-16 | Applied Biosystems, Inc. | Automated system for polynucleotide synthesis and purification |
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| US5885613A (en) | 1994-09-30 | 1999-03-23 | The University Of British Columbia | Bilayer stabilizing components and their use in forming programmable fusogenic liposomes |
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| US5744335A (en) | 1995-09-19 | 1998-04-28 | Mirus Corporation | Process of transfecting a cell with a polynucleotide mixed with an amphipathic compound and a DNA-binding protein |
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| AU2005253852B2 (en) * | 2004-06-18 | 2008-05-29 | Kabushiki Kaisha Yakult Honsha | Liposome preparation containing slightly water-soluble camptothecin |
| EP3611266B1 (en) | 2005-08-23 | 2022-11-09 | The Trustees of the University of Pennsylvania | Rna containing modified nucleosides and methods of use thereof |
| CN104119242B (zh) | 2008-10-09 | 2017-07-07 | 泰米拉制药公司 | 改善的氨基脂质和递送核酸的方法 |
| ES2646630T3 (es) | 2008-11-07 | 2017-12-14 | Massachusetts Institute Of Technology | Lipidoides aminoalcohólicos y usos de los mismos |
| MX342785B (es) | 2009-06-10 | 2016-10-12 | Alnylam Pharmaceuticals Inc | Formulacion mejorada de lipido. |
| BR112012002291A2 (pt) | 2009-07-31 | 2016-11-29 | Ethris Gmbh | "polirribonucleotídeo com uma sequência que codifica uma proteína ou fragmento de proteína, implante, e, processo para a seleção de sequências de nucleotídeos" |
| DE102011076149A1 (de) * | 2011-05-19 | 2012-11-22 | Rovi Cosmetics International Gmbh | Ladungsgeber für ein vesikuläres Trägersystem eines UV-Schutzmittels für die Haut oder die Haare |
| EP3354644A1 (en) * | 2011-06-08 | 2018-08-01 | Translate Bio, Inc. | Cleavable lipids |
| KR102451116B1 (ko) | 2011-10-27 | 2022-10-06 | 메사추세츠 인스티튜트 오브 테크놀로지 | 약물 캡슐화 마이크로스피어를 형성할 수 있는, ｎ-말단 상에 관능화된 아미노산 유도체 |
| ES2762873T3 (es) | 2012-03-29 | 2020-05-26 | Translate Bio Inc | Lípidos catiónicos ionizables |
| FR2991327B1 (fr) * | 2012-06-05 | 2018-04-13 | Hemarina | Procede de lyophilisation d'hemoglobine d'annelides |
| PL3467108T3 (pl) | 2013-03-14 | 2024-09-30 | Translate Bio, Inc. | Sposoby oczyszczania informacyjnego rna |
| CN105051213A (zh) | 2013-03-14 | 2015-11-11 | 夏尔人类遗传性治疗公司 | 信使rna加帽效率的定量评估 |
| ES2895651T3 (es) | 2013-12-19 | 2022-02-22 | Novartis Ag | Lípidos y composiciones lipídicas para la administración de agentes activos |
| PT3134506T (pt) | 2014-04-25 | 2019-10-31 | Translate Bio Inc | Métodos de purificação de rna mensageiro |
| JP6557722B2 (ja) | 2014-05-30 | 2019-08-07 | シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド | 核酸の送達のための生分解性脂質 |
| SMT202200502T1 (it) | 2014-06-25 | 2023-01-13 | Acuitas Therapeutics Inc | Nuovi lipidi e formulazioni di nanoparticelle lipidiche per l'erogazione di acidi nucleici |
| US9840479B2 (en) | 2014-07-02 | 2017-12-12 | Massachusetts Institute Of Technology | Polyamine-fatty acid derived lipidoids and uses thereof |
| US20180000953A1 (en) | 2015-01-21 | 2018-01-04 | Moderna Therapeutics, Inc. | Lipid nanoparticle compositions |
| WO2016118725A1 (en) | 2015-01-23 | 2016-07-28 | Moderna Therapeutics, Inc. | Lipid nanoparticle compositions |
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| LT3313829T (lt) | 2015-06-29 | 2024-08-12 | Acuitas Therapeutics Inc. | Lipidai ir lipidų nanodalelių sudėtys, skirtos nukleorūgščių tiekimui |
| AU2016309847B2 (en) * | 2015-08-19 | 2019-10-31 | Xiamen Ginposome Pharmaceutical Co., Ltd. | Liposomes with ginsenoside as membrane material and preparations and use thereof |
| EP4286012A3 (en) | 2015-09-17 | 2024-05-29 | ModernaTX, Inc. | Compounds and compositions for intracellular delivery of therapeutic agents |
| IL307179A (en) | 2015-10-28 | 2023-11-01 | Acuitas Therapeutics Inc | Novel lipids and lipid nanoparticle formulations for delivery of nucleic acids |
| WO2017097196A1 (zh) * | 2015-12-08 | 2017-06-15 | 正大天晴药业集团股份有限公司 | 脂质体的制备方法 |
| EP3397613A1 (en) | 2015-12-30 | 2018-11-07 | Acuitas Therapeutics Inc. | Lipids and lipid nanoparticle formulations for delivery of nucleic acids |
| TWI773666B (zh) | 2016-03-30 | 2022-08-11 | 美商英特利亞醫療公司 | Crispr/cas 組分之脂質奈米粒子調配物 |
| EP3468610A1 (en) * | 2016-06-09 | 2019-04-17 | OPKO Biologics Ltd. | Long-acting oxyntomodulin formulation and methods of producing and administering same |
| MX2019005470A (es) | 2016-11-10 | 2019-11-21 | Translate Bio Inc | Formulación de nanopartículas lipídicas basadas en ice mejorada para el suministro de arnm. |
| WO2018157133A1 (en) | 2017-02-27 | 2018-08-30 | Translate Bio, Inc. | Methods for purification of messenger rna |
| EP3585892B8 (en) | 2017-02-27 | 2022-07-13 | Translate Bio, Inc. | Methods for purification of messenger rna |
| CA3053814A1 (en) | 2017-02-27 | 2018-08-30 | Translate Bio, Inc. | Large scale synthesis of messenger rna |
| MX2019013752A (es) * | 2017-05-16 | 2020-07-20 | Translate Bio Inc | Tratamiento de la fibrosis quística mediante el suministro de arnm que codifica cftr optimizado en codones. |
| KR20210091120A (ko) * | 2018-08-29 | 2021-07-21 | 트랜슬레이트 바이오 인코포레이티드 | Mrna-로딩된 지질 나노입자를 제조하는 개선된 공정 |
-
2021
- 2021-10-06 CN CN202180076850.8A patent/CN116546976A/zh active Pending
- 2021-10-06 CA CA3194863A patent/CA3194863A1/en active Pending
- 2021-10-06 EP EP21802083.2A patent/EP4225268A1/en active Pending
- 2021-10-06 WO PCT/US2021/053776 patent/WO2022076562A1/en not_active Ceased
- 2021-10-06 AU AU2021358777A patent/AU2021358777A1/en active Pending
- 2021-10-06 JP JP2023521060A patent/JP2023544197A/ja active Pending
- 2021-10-06 US US18/247,976 patent/US20230372440A1/en active Pending
- 2021-10-06 KR KR1020237015312A patent/KR20230083323A/ko active Pending
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