JP2023552678A - 粒子およびｍＲＮＡを含む医薬組成物ならびにそれを調製および貯蔵する方法 - Google Patents

粒子およびｍＲＮＡを含む医薬組成物ならびにそれを調製および貯蔵する方法 Download PDF

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JP2023552678A
JP2023552678A JP2023528680A JP2023528680A JP2023552678A JP 2023552678 A JP2023552678 A JP 2023552678A JP 2023528680 A JP2023528680 A JP 2023528680A JP 2023528680 A JP2023528680 A JP 2023528680A JP 2023552678 A JP2023552678 A JP 2023552678A
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pharmaceutical composition
formulation
substantially free
lipid
mrna
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JPWO2022101486A5 (enExample
Inventor
ハース，ハインリヒ
タンキ，カウシク
ボルケス，イサーク エルナン エスパルサ
ヘルナー，ゼバスティアン
シディコフ，ブラート
カップ，マルティン
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Biontech SE
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Biontech SE
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/215—Coronaviridae, e.g. avian infectious bronchitis virus
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/5123—Organic compounds, e.g. fats, sugars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5192—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/20011—Coronaviridae
    • C12N2770/20034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2023528680A 2020-11-16 2021-11-15 粒子およびｍＲＮＡを含む医薬組成物ならびにそれを調製および貯蔵する方法 Pending JP2023552678A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202063114478P 2020-11-16 2020-11-16
US63/114,478 2020-11-16
EP2020082602 2020-11-18
EPPCT/EP2020/082602 2020-11-18
PCT/EP2021/081741 WO2022101486A1 (en) 2020-11-16 2021-11-15 Pharmaceutical compositions comprising particles and mrna and methods for preparing and storing the same

Publications (2)

Publication Number Publication Date
JP2023552678A true JP2023552678A (ja) 2023-12-19
JPWO2022101486A5 JPWO2022101486A5 (enExample) 2024-11-22

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JP2023528680A Pending JP2023552678A (ja) 2020-11-16 2021-11-15 粒子およびｍＲＮＡを含む医薬組成物ならびにそれを調製および貯蔵する方法

Country Status (6)

Country Link
US (1) US20240033344A1 (enExample)
EP (1) EP4243787A1 (enExample)
JP (1) JP2023552678A (enExample)
AU (1) AU2021377746A1 (enExample)
CA (1) CA3198309A1 (enExample)
WO (2) WO2022101486A1 (enExample)

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US11524023B2 (en) * 2021-02-19 2022-12-13 Modernatx, Inc. Lipid nanoparticle compositions and methods of formulating the same
CN114989182B (zh) * 2022-06-23 2023-06-23 尧唐(上海)生物科技有限公司 脂质化合物、包含其的组合物及应用
WO2024006863A1 (en) * 2022-06-30 2024-01-04 Precision NanoSystems ULC Lipid nanoparticle formulations for vaccines
CN115869394A (zh) * 2022-07-21 2023-03-31 中国食品药品检定研究院 核酸佐剂、含有所述核酸佐剂的疫苗及应用
AU2023408183A1 (en) * 2022-12-23 2025-07-10 Eli Lilly And Company Stabilization of lipid nanoparticle formulations
WO2024160829A1 (en) 2023-01-31 2024-08-08 BioNTech SE Compositions and methods
US11833224B1 (en) * 2023-02-08 2023-12-05 Leuvian Llc Lyoprotectant compositions and uses thereof
WO2024184500A1 (en) * 2023-03-08 2024-09-12 CureVac SE Novel lipid nanoparticle formulations for delivery of nucleic acids
WO2024193827A1 (en) * 2023-03-23 2024-09-26 BioNTech SE Stabilized nucleic acid compositions and methods for preparing, storing and using the same
EP4442256A1 (en) * 2023-04-04 2024-10-09 Københavns Universitet Lipid nanoparticle compositions
TW202446402A (zh) * 2023-04-12 2024-12-01 美商艾拉倫製藥公司 用於寡核苷酸遞送之調配物
WO2024249954A1 (en) 2023-05-31 2024-12-05 Capstan Therapeutics, Inc. Lipid nanoparticle formulations and compositions
AU2023457883A1 (en) * 2023-06-28 2025-12-18 Global Life Sciences Solutions Canada Ulc Lipid nanoparticle formulations for cell therapy and related methods
WO2025040724A1 (en) * 2023-08-21 2025-02-27 Global Life Sciences Solutions Canada Ulc Method and apparatus for ion flux lipid nanoparticle manufacture
WO2025061153A1 (en) * 2023-09-22 2025-03-27 Everest Medicines (China) Co., Ltd. Rna-lipid particles comprising polysarcosine-lipid conjugate
WO2025087303A1 (en) * 2023-10-24 2025-05-01 Mote Therapeutics Inc. Lipid nanoparticle with non-covalent bifunctional binders for active targeting
WO2025133105A1 (en) * 2023-12-21 2025-06-26 Biontech Delivery Technologies Gmbh Compositions and methods
WO2025176732A1 (en) 2024-02-20 2025-08-28 BioNTech SE Compositions and methods

Citations (5)

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JP2016534992A (ja) * 2013-10-22 2016-11-10 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 アルギニノコハク酸合成酵素欠損症のｍＲＮＡ治療
JP2018533573A (ja) * 2015-10-28 2018-11-15 アキィタス・セラピューティクス・インコーポレイテッドＡｃｕｉｔａｓ Ｔｈｅｒａｐｅｕｔｉｃｓ Ｉｎｃ． 核酸のデリバリーのための新規脂質および脂質ナノ粒子製剤
JP2019525901A (ja) * 2016-06-14 2019-09-12 モデルナティエックス インコーポレイテッドＭｏｄｅｒｎａＴＸ，Ｉｎｃ． 脂質ナノ粒子の安定化製剤
JP2020504764A (ja) * 2016-10-26 2020-02-13 キュアバック アーゲー 脂質ナノ粒子ｍＲＮＡワクチン
WO2020072605A1 (en) * 2018-10-02 2020-04-09 Intellia Therapeutics, Inc. Ionizable amine lipids

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DE102005046490A1 (de) 2005-09-28 2007-03-29 Johannes-Gutenberg-Universität Mainz Modifikationen von RNA, die zu einer erhöhten Transkriptstabilität und Translationseffizienz führen
WO2016005004A1 (en) 2014-07-11 2016-01-14 Biontech Rna Pharmaceuticals Gmbh Stabilization of poly(a) sequence encoding dna sequences
CA2984125A1 (en) 2015-04-27 2016-11-03 The Trustees Of The University Of Pennsylvania Nucleoside-modified rna for inducing an adaptive immune response
ES2900272T3 (es) 2016-04-22 2022-03-16 BioNTech SE Métodos para proporcionar ARN monocatenario

Patent Citations (5)

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Publication number Priority date Publication date Assignee Title
JP2016534992A (ja) * 2013-10-22 2016-11-10 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 アルギニノコハク酸合成酵素欠損症のｍＲＮＡ治療
JP2018533573A (ja) * 2015-10-28 2018-11-15 アキィタス・セラピューティクス・インコーポレイテッドＡｃｕｉｔａｓ Ｔｈｅｒａｐｅｕｔｉｃｓ Ｉｎｃ． 核酸のデリバリーのための新規脂質および脂質ナノ粒子製剤
JP2019525901A (ja) * 2016-06-14 2019-09-12 モデルナティエックス インコーポレイテッドＭｏｄｅｒｎａＴＸ，Ｉｎｃ． 脂質ナノ粒子の安定化製剤
JP2020504764A (ja) * 2016-10-26 2020-02-13 キュアバック アーゲー 脂質ナノ粒子ｍＲＮＡワクチン
WO2020072605A1 (en) * 2018-10-02 2020-04-09 Intellia Therapeutics, Inc. Ionizable amine lipids

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AU2021377746A9 (en) 2024-09-26
WO2022101471A1 (en) 2022-05-19
AU2021377746A1 (en) 2023-06-08
US20240033344A1 (en) 2024-02-01
CA3198309A1 (en) 2022-05-19
WO2022101486A1 (en) 2022-05-19
EP4243787A1 (en) 2023-09-20

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