CA3050629A1 - Novel formulation - Google Patents

Novel formulation Download PDF

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Publication number
CA3050629A1
CA3050629A1 CA3050629A CA3050629A CA3050629A1 CA 3050629 A1 CA3050629 A1 CA 3050629A1 CA 3050629 A CA3050629 A CA 3050629A CA 3050629 A CA3050629 A CA 3050629A CA 3050629 A1 CA3050629 A1 CA 3050629A1
Authority
CA
Canada
Prior art keywords
composition according
nnm
composition
sorbitol
trehalose
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
Application number
CA3050629A
Other languages
English (en)
French (fr)
Inventor
Erwan BOURLES
Olivier DESPAS
Delphine GUILLAUME
Frederic MATHOT
Mathieu VASSELLE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GlaxoSmithKline Biologicals SA
Original Assignee
GlaxoSmithKline Biologicals SA
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 GlaxoSmithKline Biologicals SA filed Critical GlaxoSmithKline Biologicals SA
Publication of CA3050629A1 publication Critical patent/CA3050629A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0091Purification or manufacturing processes for gene therapy compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86Viral vectors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/10011Adenoviridae
    • C12N2710/10111Atadenovirus, e.g. ovine adenovirus D
    • C12N2710/10132Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/10011Adenoviridae
    • C12N2710/10111Atadenovirus, e.g. ovine adenovirus D
    • C12N2710/10141Use of virus, viral particle or viral elements as a vector
    • C12N2710/10143Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Immunology (AREA)
  • Plant Pathology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Manufacturing & Machinery (AREA)
  • Inorganic Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA3050629A 2017-01-25 2018-01-25 Novel formulation Pending CA3050629A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1701239.4 2017-01-25
GBGB1701239.4A GB201701239D0 (en) 2017-01-25 2017-01-25 Novel formulation
PCT/IB2018/050453 WO2018138667A1 (en) 2017-01-25 2018-01-25 Novel formulation

Publications (1)

Publication Number Publication Date
CA3050629A1 true CA3050629A1 (en) 2018-08-02

Family

ID=58462949

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3050629A Pending CA3050629A1 (en) 2017-01-25 2018-01-25 Novel formulation

Country Status (10)

Country Link
US (1) US11590243B2 (enExample)
EP (1) EP3573598A1 (enExample)
JP (1) JP7090089B2 (enExample)
CN (1) CN110430867B (enExample)
BE (1) BE1025187B1 (enExample)
BR (1) BR112019015245A2 (enExample)
CA (1) CA3050629A1 (enExample)
GB (1) GB201701239D0 (enExample)
MX (1) MX2019008798A (enExample)
WO (1) WO2018138667A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201513010D0 (en) * 2015-07-23 2015-09-09 Glaxosmithkline Biolog Sa Novel formulation
EP3587581A1 (en) * 2018-06-26 2020-01-01 GlaxoSmithKline Biologicals S.A. Formulations for simian adenoviral vectors having enhanced storage stability
BR112021025025A2 (pt) * 2019-06-11 2022-02-22 Glaxosmithkline Biologicals Sa Formulações de vacinas de mucosa
JP2023548838A (ja) * 2020-10-29 2023-11-21 フラッグシップ パイオニアリング イノベーションズ ブイ, インコーポレイテッド ニワトリ貧血ウイルス(cav)に基づくベクター
US20230414516A1 (en) * 2020-11-16 2023-12-28 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes
CN116782889A (zh) * 2020-11-16 2023-09-19 生物技术欧洲股份公司 增强的制剂稳定性和改善的冻干工艺
CN114903922B (zh) * 2021-02-09 2024-04-26 武汉博沃生物科技有限公司 包含腺病毒的医药配制品及其保存方法

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9808922D0 (en) * 1998-04-24 1998-06-24 Cantab Pharmaceuticals Res Ltd Virus preparations
US7456009B2 (en) * 2000-03-07 2008-11-25 Merck & Co., Inc. Adenovirus formulations
SI1409012T1 (sl) 2001-06-22 2009-08-31 Wistar Inst Postopki za induciranje citotoksičnega imunskega odziva in za to uporabni sestavki rekombinantnih opičjih adenovirusov
WO2005071093A2 (en) 2004-01-23 2005-08-04 Istituto Di Ricerche Di Biologia Molecolare P Angeletti Spa Chimpanzee adenovirus vaccine carriers
PT1954308E (pt) 2005-09-16 2011-11-03 Merial Ltd Estabilizadores para vacinas liofilizadas
EA021391B1 (ru) 2007-03-02 2015-06-30 Глаксосмитклайн Байолоджикалс С.А. Способ индукции иммунного ответа, вакцинная композиция, ее применение и набор
WO2010085984A1 (en) 2009-02-02 2010-08-05 Okairos Ag Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof
SI2391638T1 (sl) 2009-02-02 2018-10-30 Glaxosmithkline Biologicals Sa Nukleinskokislinske in aminokislinske sekvence opičjega adenovirusa, vektorji, ki le-te vsebujejo, in njihova uporaba
CN102028954B (zh) 2009-09-29 2012-11-07 成都康弘生物科技有限公司 一种重组腺病毒的制剂
US9526777B2 (en) 2010-04-16 2016-12-27 The United States Of America As Represented By The Department Of Health And Human Services Methods for the induction of ebola virus-specific immune responses comprising administering a replication-defective chimpanzee adenovirus vector expressing the ebola virus glycoprotein
WO2012089231A1 (en) 2010-12-30 2012-07-05 Okairòs Ag Paramyxovirus vaccines
BR112014008167B1 (pt) 2011-10-05 2022-05-24 Genvec Inc Adenovírus ou vetor adenoviral e composição os compreendendo
CN107574154A (zh) 2011-10-05 2018-01-12 金维克有限公司 猴(大猩猩)腺病毒或腺病毒载体及其使用方法
CN103974970B (zh) 2011-10-05 2018-01-02 金维克有限公司 猴腺病毒(大猩猩)或腺病毒载体及其使用方法
CN102631672B (zh) 2012-04-27 2014-04-02 天津百若克医药生物技术有限责任公司 一种冻干灭活乙型脑炎疫苗
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
JP6664338B2 (ja) 2014-06-13 2020-03-13 グラクソスミスクライン バイオロジカルズ ソシエテ アノニム 免疫原性組合せ物

Also Published As

Publication number Publication date
US20190365930A1 (en) 2019-12-05
WO2018138667A1 (en) 2018-08-02
CN110430867A (zh) 2019-11-08
EP3573598A1 (en) 2019-12-04
BR112019015245A2 (pt) 2020-04-14
JP2020506691A (ja) 2020-03-05
GB201701239D0 (en) 2017-03-08
JP7090089B2 (ja) 2022-06-23
US11590243B2 (en) 2023-02-28
CN110430867B (zh) 2023-04-07
BE1025187B1 (fr) 2018-12-03
MX2019008798A (es) 2019-09-11
BE1025187A1 (fr) 2018-11-27

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