MX2020003413A - Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia. - Google Patents
Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia.Info
- Publication number
- MX2020003413A MX2020003413A MX2020003413A MX2020003413A MX2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A MX 2020003413 A MX2020003413 A MX 2020003413A
- Authority
- MX
- Mexico
- Prior art keywords
- rna
- therapy
- preparation
- storage
- present disclosure
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
- A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7088—Compounds having three or more nucleosides or nucleotides
- A61K31/713—Double-stranded nucleic acids or oligonucleotides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61K48/0008—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61K48/0075—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the delivery route, e.g. oral, subcutaneous
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1277—Processes for preparing; Proliposomes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Dispersion Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
La presente descripción se relaciona con un método para preparar partículas de lipoplejo-ARN para el suministro de ARN a los tejidos objetivo, después de la administración parenteral, en particular después de la administración intravenosa, y las composiciones que comprenden tales partículas de lipoplejo-ARN. La presente descripción también se relaciona con métodos que permiten preparar las partículas de lipoplejo-ARN de una manera industrial que cumple con las GMP. Además, la presente descripción se relaciona con un método y con composiciones para almacenar las partículas de lipoplejo-ARN sin la pérdida sustancial de la calidad del producto y en particular, sin la pérdida sustancial de la actividad del ARN.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762574965P | 2017-10-20 | 2017-10-20 | |
PCT/EP2018/078587 WO2019077053A1 (en) | 2017-10-20 | 2018-10-18 | PREPARATION AND STORAGE OF APPROPRIATE LIPOSOMAL RNA FORMULATIONS FOR THERAPY |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2020003413A true MX2020003413A (es) | 2020-07-20 |
Family
ID=63965663
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2020003413A MX2020003413A (es) | 2017-10-20 | 2018-10-18 | Preparacion y almacenamiento de formulaciones liposomales de arn adecuadas para terapia. |
Country Status (16)
Country | Link |
---|---|
US (2) | US11395799B2 (es) |
EP (2) | EP3697384A1 (es) |
JP (2) | JP2021500324A (es) |
KR (1) | KR20200100619A (es) |
CN (3) | CN114392233A (es) |
AR (2) | AR113782A1 (es) |
AU (2) | AU2018350846B2 (es) |
BR (1) | BR112020007470A2 (es) |
CA (1) | CA3078292A1 (es) |
IL (1) | IL273852A (es) |
MX (1) | MX2020003413A (es) |
RU (1) | RU2022103533A (es) |
SG (1) | SG11202002579SA (es) |
TW (2) | TW201927288A (es) |
WO (1) | WO2019077053A1 (es) |
ZA (1) | ZA202001675B (es) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至her2結構域ii之抗體及其酸性變異體的組合物 |
BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
US11077189B2 (en) | 2017-03-02 | 2021-08-03 | Genentech Inc. | Adjuvant treatment of HER2-positive breast cancer |
EP3697384A1 (en) | 2017-10-20 | 2020-08-26 | BioNTech RNA Pharmaceuticals GmbH | Preparation and storage of liposomal rna formulations suitable for therapy |
CA3088485A1 (en) * | 2018-01-18 | 2019-07-25 | Etherna Immunotherapies Nv | Lipid nanoparticles |
WO2020200472A1 (en) * | 2019-04-05 | 2020-10-08 | Biontech Rna Pharmaceuticals Gmbh | Preparation and storage of liposomal rna formulations suitable for therapy |
MX2023002670A (es) | 2020-09-08 | 2023-05-08 | Genentech Inc | Sistemas y procedimientos para producir composiciones farmaceuticas usando bombas peristalticas y amortiguadores. |
TW202228727A (zh) * | 2020-10-01 | 2022-08-01 | 德商拜恩迪克公司 | 適用於治療之微脂體rna調配物之製備及儲存 |
CA3209153A1 (en) * | 2021-02-23 | 2022-09-01 | Alexander Koglin | Lipid nanoparticle (lnp) encapsulation of mrna products |
EP4334943A1 (en) | 2021-05-04 | 2024-03-13 | BioNTech SE | Technologies for early detection of variants of interest |
WO2023006920A1 (en) | 2021-07-29 | 2023-02-02 | BioNTech SE | Compositions and methods for treatment of melanoma |
WO2023057596A1 (en) | 2021-10-06 | 2023-04-13 | Leon-Nanodrugs Gmbh | Method for preparing lipid nanoparticles |
CN114601747A (zh) * | 2022-03-07 | 2022-06-10 | 广州市万千粉丝化妆品有限公司 | 一种催生蛋白及rna具有延长细胞端粒和增殖的核蛋白端粒酶在化妆品中的应用 |
WO2024011033A1 (en) | 2022-07-07 | 2024-01-11 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Immunogens and methods for inducing an immune response |
WO2024056856A1 (en) | 2022-09-15 | 2024-03-21 | BioNTech SE | Systems and compositions comprising trans-amplifying rna vectors with mirna |
Family Cites Families (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR0012624B1 (pt) * | 1999-07-15 | 2011-08-09 | métodos para a preparação de agentes terapêuticos envolvidos por lipìdeos. | |
DE10109897A1 (de) | 2001-02-21 | 2002-11-07 | Novosom Ag | Fakultativ kationische Liposomen und Verwendung dieser |
WO2003049764A1 (en) * | 2001-12-12 | 2003-06-19 | Fh Faulding & Co Limited | Composition for viral preservation |
US7008403B1 (en) | 2002-07-19 | 2006-03-07 | Cognitive Ventures Corporation | Infusion pump and method for use |
CN1798545B (zh) * | 2003-06-04 | 2013-06-05 | 乔治敦大学 | 改良脂质体复合物的稳定性和保存期的方法 |
EP1512393A1 (de) * | 2003-09-08 | 2005-03-09 | BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG | Verfahren zur Herstellung von homogenen Liposomen und Lipoplexen |
WO2009111088A2 (en) * | 2008-01-02 | 2009-09-11 | The Johns Hopkins University | Antitumor immunization by liposomal delivery of vaccine to the spleen |
CN102203125A (zh) | 2008-08-25 | 2011-09-28 | 安普利穆尼股份有限公司 | Pd-1拮抗剂及其使用方法 |
WO2011066342A2 (en) | 2009-11-24 | 2011-06-03 | Amplimmune, Inc. | Simultaneous inhibition of pd-l1/pd-l2 |
EP3391877A1 (en) * | 2010-04-08 | 2018-10-24 | The Trustees of Princeton University | Preparation of lipid nanoparticles |
JP6054308B2 (ja) * | 2011-02-15 | 2016-12-27 | メリマック ファーマシューティカルズ, インコーポレイテッドMerrimack Pharmaceuticals, Inc. | 核酸を細胞へ送達する組成物及び方法 |
CN102144973A (zh) | 2011-03-31 | 2011-08-10 | 中国药科大学 | 一种优化的siRNA阳离子脂质体的处方组成 |
CN102727436A (zh) | 2011-04-15 | 2012-10-17 | 百奥迈科生物技术有限公司 | 核酸脂质体药物制剂 |
EP2773328A2 (en) | 2011-11-04 | 2014-09-10 | Nitto Denko Corporation | Method of producing lipid nanoparticles for drug delivery |
DK3427723T3 (da) * | 2012-03-26 | 2020-10-12 | Biontech Rna Pharmaceuticals Gmbh | Rna-formulering til immunterapi |
WO2013143555A1 (en) | 2012-03-26 | 2013-10-03 | Biontech Ag | Rna formulation for immunotherapy |
CN103194489B (zh) | 2013-03-26 | 2015-09-30 | 中国科学院过程工程研究所 | 新型阳离子脂质体核酸类药物制剂,及其制备方法和应用 |
SG11201510751YA (en) * | 2013-08-21 | 2016-03-30 | Curevac Ag | Composition and vaccine for treating prostate cancer |
WO2015043613A1 (en) * | 2013-09-26 | 2015-04-02 | Biontech Ag | Particles comprising a shell with rna |
WO2016045732A1 (en) | 2014-09-25 | 2016-03-31 | Biontech Rna Pharmaceuticals Gmbh | Stable formulations of lipids and liposomes |
AU2016222746A1 (en) * | 2015-02-24 | 2017-09-07 | The University Of British Columbia | Continuous flow microfluidic system |
CA2977827C (en) * | 2015-03-19 | 2023-10-17 | University Of Connecticut | Systems and methods for continuous manufacturing of liposomal drug formulations |
WO2016155809A1 (en) * | 2015-03-31 | 2016-10-06 | Biontech Rna Pharmaceuticals Gmbh | Lipid particle formulations for delivery of rna and water-soluble therapeutically effective compounds to a target cell |
EP3697384A1 (en) | 2017-10-20 | 2020-08-26 | BioNTech RNA Pharmaceuticals GmbH | Preparation and storage of liposomal rna formulations suitable for therapy |
-
2018
- 2018-10-18 EP EP18792901.3A patent/EP3697384A1/en active Pending
- 2018-10-18 KR KR1020207014348A patent/KR20200100619A/ko not_active Application Discontinuation
- 2018-10-18 CN CN202210003912.9A patent/CN114392233A/zh active Pending
- 2018-10-18 SG SG11202002579SA patent/SG11202002579SA/en unknown
- 2018-10-18 JP JP2020520738A patent/JP2021500324A/ja active Pending
- 2018-10-18 TW TW107136678A patent/TW201927288A/zh unknown
- 2018-10-18 TW TW110132980A patent/TW202146031A/zh unknown
- 2018-10-18 WO PCT/EP2018/078587 patent/WO2019077053A1/en unknown
- 2018-10-18 CN CN201880068224.2A patent/CN111246845A/zh active Pending
- 2018-10-18 AU AU2018350846A patent/AU2018350846B2/en active Active
- 2018-10-18 US US16/757,054 patent/US11395799B2/en active Active
- 2018-10-18 MX MX2020003413A patent/MX2020003413A/es unknown
- 2018-10-18 BR BR112020007470-5A patent/BR112020007470A2/pt unknown
- 2018-10-18 CA CA3078292A patent/CA3078292A1/en active Pending
- 2018-10-18 CN CN202210004497.9A patent/CN114344486A/zh active Pending
- 2018-10-18 RU RU2022103533A patent/RU2022103533A/ru unknown
- 2018-10-18 EP EP21151194.4A patent/EP3858333A1/en active Pending
- 2018-10-19 AR ARP180103065A patent/AR113782A1/es unknown
-
2020
- 2020-03-17 ZA ZA2020/01675A patent/ZA202001675B/en unknown
- 2020-04-06 IL IL273852A patent/IL273852A/en unknown
-
2021
- 2021-02-08 US US17/170,826 patent/US20210161818A1/en active Pending
-
2022
- 2022-10-13 AR ARP220102789A patent/AR127361A2/es unknown
-
2023
- 2023-01-04 JP JP2023000105A patent/JP2023052184A/ja active Pending
- 2023-02-28 AU AU2023201185A patent/AU2023201185A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20200246267A1 (en) | 2020-08-06 |
TW202146031A (zh) | 2021-12-16 |
CN114344486A (zh) | 2022-04-15 |
BR112020007470A2 (pt) | 2020-10-27 |
ZA202001675B (en) | 2021-07-28 |
EP3697384A1 (en) | 2020-08-26 |
AU2023201185A1 (en) | 2023-04-06 |
RU2020113577A (ru) | 2021-11-22 |
CN111246845A (zh) | 2020-06-05 |
AR113782A1 (es) | 2020-06-10 |
WO2019077053A1 (en) | 2019-04-25 |
US20210161818A1 (en) | 2021-06-03 |
US11395799B2 (en) | 2022-07-26 |
AR127361A2 (es) | 2024-01-17 |
TW201927288A (zh) | 2019-07-16 |
KR20200100619A (ko) | 2020-08-26 |
RU2020113577A3 (es) | 2022-02-16 |
RU2022103533A (ru) | 2022-03-10 |
CN114392233A (zh) | 2022-04-26 |
CA3078292A1 (en) | 2019-04-25 |
JP2021500324A (ja) | 2021-01-07 |
EP3858333A1 (en) | 2021-08-04 |
IL273852A (en) | 2020-05-31 |
AU2018350846A1 (en) | 2020-04-23 |
SG11202002579SA (en) | 2020-05-28 |
JP2023052184A (ja) | 2023-04-11 |
AU2018350846B2 (en) | 2022-12-08 |
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