BE1025187B1 - Nouvelle formulation - Google Patents

Nouvelle formulation Download PDF

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Publication number
BE1025187B1
BE1025187B1 BE2018/5040A BE201805040A BE1025187B1 BE 1025187 B1 BE1025187 B1 BE 1025187B1 BE 2018/5040 A BE2018/5040 A BE 2018/5040A BE 201805040 A BE201805040 A BE 201805040A BE 1025187 B1 BE1025187 B1 BE 1025187B1
Authority
BE
Belgium
Prior art keywords
composition according
composition
sorbitol
trehalose
aqueous mixture
Prior art date
Application number
BE2018/5040A
Other languages
English (en)
French (fr)
Other versions
BE1025187A1 (fr
Inventor
Erwan Bourles
Olivier Despas
Delphine Guillaume
Frédéric Mathot
Mathieu Vasselle
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 BE1025187A1 publication Critical patent/BE1025187A1/fr
Application granted granted Critical
Publication of BE1025187B1 publication Critical patent/BE1025187B1/fr

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    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Plant Pathology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physics & Mathematics (AREA)
  • Manufacturing & Machinery (AREA)
  • Inorganic Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
BE2018/5040A 2017-01-25 2018-01-25 Nouvelle formulation BE1025187B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1701239.4 2017-01-25
GBGB1701239.4A GB201701239D0 (en) 2017-01-25 2017-01-25 Novel formulation

Publications (2)

Publication Number Publication Date
BE1025187A1 BE1025187A1 (fr) 2018-11-27
BE1025187B1 true BE1025187B1 (fr) 2018-12-03

Family

ID=58462949

Family Applications (1)

Application Number Title Priority Date Filing Date
BE2018/5040A BE1025187B1 (fr) 2017-01-25 2018-01-25 Nouvelle formulation

Country Status (10)

Country Link
US (1) US11590243B2 (cg-RX-API-DMAC7.html)
EP (1) EP3573598A1 (cg-RX-API-DMAC7.html)
JP (1) JP7090089B2 (cg-RX-API-DMAC7.html)
CN (1) CN110430867B (cg-RX-API-DMAC7.html)
BE (1) BE1025187B1 (cg-RX-API-DMAC7.html)
BR (1) BR112019015245A2 (cg-RX-API-DMAC7.html)
CA (1) CA3050629A1 (cg-RX-API-DMAC7.html)
GB (1) GB201701239D0 (cg-RX-API-DMAC7.html)
MX (1) MX2019008798A (cg-RX-API-DMAC7.html)
WO (1) WO2018138667A1 (cg-RX-API-DMAC7.html)

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
IL302332A (en) * 2020-10-29 2023-06-01 Flagship Pioneering Innovations V Inc Chicken anemia virus (cav)-based vectors
CN116829134A (zh) * 2020-11-16 2023-09-29 生物技术欧洲股份公司 包含rna的lnp组合物及其制备、储存和使用方法
US20230414516A1 (en) * 2020-11-16 2023-12-28 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes
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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050186225A1 (en) * 2000-03-07 2005-08-25 Evans Robert K. Adenovirus formulations
US20100260796A1 (en) * 2005-09-16 2010-10-14 Delphine Magali Belin-Poput Stabilizers for freeze-dried vaccines
US20160228369A1 (en) * 2013-09-27 2016-08-11 Intervet Inc. Dry Formulations of Vaccines That Are Room Temperature Stable

Family Cites Families (14)

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GB9808922D0 (en) * 1998-04-24 1998-06-24 Cantab Pharmaceuticals Res Ltd Virus preparations
BR0210586A (pt) 2001-06-22 2005-07-12 Wistar Inst Métodos para induzir uma reação imune citotóxica e composições de adenovìrus de sìmio recombinante úteis das mesmas
CA2993042A1 (en) 2004-01-23 2005-08-04 Msd Italia S.R.L. Chimpanzee adenovirus vaccine carriers
HRP20161606T1 (hr) 2007-03-02 2017-01-13 Glaxosmithkline Biologicals Sa Novi postupak i pripravci
WO2010085984A1 (en) * 2009-02-02 2010-08-05 Okairos Ag Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof
EP3385387B1 (en) * 2009-02-02 2021-08-25 GlaxoSmithKline Biologicals SA Simian adenovirus nucleic acid- and amino acid-sequences, vectors containing same, and uses thereof
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
TR201902214T4 (tr) 2010-04-16 2019-03-21 Glaxosmithkline Biologicals Sa Şempanze adenoviral vektörü-bazlı filovirüs aşıları.
WO2012089231A1 (en) 2010-12-30 2012-07-05 Okairòs Ag Paramyxovirus vaccines
IN2014DN03061A (cg-RX-API-DMAC7.html) 2011-10-05 2015-05-15 Genvec Inc
CA2851251C (en) 2011-10-05 2023-09-12 Genvec, Inc. Simian (gorilla) adenovirus or adenoviral vectors and methods of use
IN2014DN03005A (cg-RX-API-DMAC7.html) 2011-10-05 2015-05-08 Genvec Inc
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
MX384992B (es) 2014-06-13 2025-03-14 Glaxosmithkline Biologicals Sa Combinaciones inmunógenas.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050186225A1 (en) * 2000-03-07 2005-08-25 Evans Robert K. Adenovirus formulations
US20100260796A1 (en) * 2005-09-16 2010-10-14 Delphine Magali Belin-Poput Stabilizers for freeze-dried vaccines
US20160228369A1 (en) * 2013-09-27 2016-08-11 Intervet Inc. Dry Formulations of Vaccines That Are Room Temperature Stable

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BORIS PASTORINO ET AL: "Effect of Chemical Stabilizers on the Thermostability and Infectivity of a Representative Panel of Freeze Dried Viruses", PLOS ONE, vol. 10, no. 4, 29 April 2015 (2015-04-29), pages e0118963, XP055345964, DOI: 10.1371/journal.pone.0118963 *
SEARLES J A ET AL: "Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg' in pharmaceutical lyophilization", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 90, no. 7, 1 July 2001 (2001-07-01), pages 872 - 887, XP002303281, ISSN: 0022-3549, DOI: 10.1002/JPS.1040 *

Also Published As

Publication number Publication date
CN110430867B (zh) 2023-04-07
MX2019008798A (es) 2019-09-11
BR112019015245A2 (pt) 2020-04-14
CA3050629A1 (en) 2018-08-02
BE1025187A1 (fr) 2018-11-27
JP7090089B2 (ja) 2022-06-23
US11590243B2 (en) 2023-02-28
CN110430867A (zh) 2019-11-08
JP2020506691A (ja) 2020-03-05
US20190365930A1 (en) 2019-12-05
EP3573598A1 (en) 2019-12-04
WO2018138667A1 (en) 2018-08-02
GB201701239D0 (en) 2017-03-08

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FG Patent granted

Effective date: 20181203

MM Lapsed because of non-payment of the annual fee

Effective date: 20200131