AR113782A1 - Preparación y almacenamiento de formulaciones de arn liposomal adecuadas para tratamiento - Google Patents

Preparación y almacenamiento de formulaciones de arn liposomal adecuadas para tratamiento

Info

Publication number
AR113782A1
AR113782A1 ARP180103065A ARP180103065A AR113782A1 AR 113782 A1 AR113782 A1 AR 113782A1 AR P180103065 A ARP180103065 A AR P180103065A AR P180103065 A ARP180103065 A AR P180103065A AR 113782 A1 AR113782 A1 AR 113782A1
Authority
AR
Argentina
Prior art keywords
rna
lipoplex
preparation
particles
treatment
Prior art date
Application number
ARP180103065A
Other languages
English (en)
Inventor
Ferdia Bates
Thomas Michael Hiller
Borquez Isaac Hernan Esparza
Sebastian Hrner
Heinrich Haas
Original Assignee
Biontech Rna Pharmaceuticals Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biontech Rna Pharmaceuticals Gmbh filed Critical Biontech Rna Pharmaceuticals Gmbh
Publication of AR113782A1 publication Critical patent/AR113782A1/es

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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (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 se refiere a los métodos para preparar partículas de lipoplejos y ARN para el aporte de ARN a los tejidos específicos después de la administración parenteral, en particular después de la administración intravenosa, y las composiciones que comprenden dichas partículas de lipoplejos y ARN. La presente además, se refiere a los métodos que permiten la preparación de partículas de lipoplejos y ARN de una manera que cumpla con las Buenas Prácticas de Fabricación Industrial. Más aún, la presente se refiere a los métodos y a las composiciones para almacenar las partículas de lipoplejos y ARN sin la pérdida sustancial de la calidad del producto y, en particular, sin la pérdida sustancial de la actividad del ARN.
ARP180103065A 2017-10-20 2018-10-19 Preparación y almacenamiento de formulaciones de arn liposomal adecuadas para tratamiento AR113782A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762574965P 2017-10-20 2017-10-20

Publications (1)

Publication Number Publication Date
AR113782A1 true AR113782A1 (es) 2020-06-10

Family

ID=63965663

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP180103065A AR113782A1 (es) 2017-10-20 2018-10-19 Preparación y almacenamiento de formulaciones de arn liposomal adecuadas para tratamiento
ARP220102789A AR127361A2 (es) 2017-10-20 2022-10-13 Composición farmacéutica de partículas de lipoplejos y arn, composición acuosa y método de preparación

Family Applications After (1)

Application Number Title Priority Date Filing Date
ARP220102789A AR127361A2 (es) 2017-10-20 2022-10-13 Composición farmacéutica de partículas de lipoplejos y arn, composición acuosa y método de preparación

Country Status (16)

Country Link
US (2) US11395799B2 (es)
EP (2) EP3858333A1 (es)
JP (2) JP2021500324A (es)
KR (1) KR20200100619A (es)
CN (3) CN111246845A (es)
AR (2) AR113782A1 (es)
AU (2) AU2018350846B2 (es)
BR (1) BR112020007470A2 (es)
CA (1) CA3078292A1 (es)
IL (1) IL273852A (es)
MX (2) MX2020003413A (es)
RU (1) RU2022103533A (es)
SG (1) SG11202002579SA (es)
TW (2) TW201927288A (es)
WO (1) WO2019077053A1 (es)
ZA (1) ZA202001675B (es)

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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
KR102417583B1 (ko) 2017-03-02 2022-07-07 제넨테크, 인크. Her2-양성 유방암 어쥬번트 치료
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EP3740241A1 (en) * 2018-01-18 2020-11-25 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
AU2021341829A1 (en) 2020-09-08 2023-04-06 BioNTech SE Systems and methods for producing pharmaceutical compositions using peristaltic pumps and dampeners
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
BR112023016897A2 (pt) * 2021-02-23 2023-11-21 Natures Toolbox Inc Encapsulação de nanopartículas lipídicas (lnp) de produtos de mrna
AU2022270658A1 (en) 2021-05-04 2023-11-16 BioNTech SE Technologies for early detection of variants of interest
BR112024001180A2 (pt) 2021-07-29 2024-04-30 BioNTech SE Composições e métodos para tratamento do 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

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Also Published As

Publication number Publication date
MX2024001218A (es) 2024-02-12
CA3078292A1 (en) 2019-04-25
EP3697384A1 (en) 2020-08-26
BR112020007470A2 (pt) 2020-10-27
SG11202002579SA (en) 2020-05-28
ZA202001675B (en) 2021-07-28
US20210161818A1 (en) 2021-06-03
US11395799B2 (en) 2022-07-26
AR127361A2 (es) 2024-01-17
JP2023052184A (ja) 2023-04-11
RU2020113577A3 (es) 2022-02-16
IL273852A (en) 2020-05-31
EP3858333A1 (en) 2021-08-04
TW201927288A (zh) 2019-07-16
US20200246267A1 (en) 2020-08-06
RU2022103533A (ru) 2022-03-10
CN114392233A (zh) 2022-04-26
KR20200100619A (ko) 2020-08-26
JP2021500324A (ja) 2021-01-07
WO2019077053A1 (en) 2019-04-25
AU2023201185A1 (en) 2023-04-06
MX2020003413A (es) 2020-07-20
CN111246845A (zh) 2020-06-05
TW202146031A (zh) 2021-12-16
RU2020113577A (ru) 2021-11-22
AU2018350846A1 (en) 2020-04-23
CN114344486A (zh) 2022-04-15
AU2018350846B2 (en) 2022-12-08
US12059498B2 (en) 2024-08-13

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