BR112019015245A2 - composição, kit, mistura aquosa, e, método para preparação da composição. - Google Patents

composição, kit, mistura aquosa, e, método para preparação da composição. Download PDF

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Publication number
BR112019015245A2
BR112019015245A2 BR112019015245A BR112019015245A BR112019015245A2 BR 112019015245 A2 BR112019015245 A2 BR 112019015245A2 BR 112019015245 A BR112019015245 A BR 112019015245A BR 112019015245 A BR112019015245 A BR 112019015245A BR 112019015245 A2 BR112019015245 A2 BR 112019015245A2
Authority
BR
Brazil
Prior art keywords
composition according
composition
fact
sorbitol
aqueous mixture
Prior art date
Application number
BR112019015245A
Other languages
English (en)
Portuguese (pt)
Inventor
Guillaume Delphine
BOURLES Erwan
Mathot Frédéric
VASSELLE Mathieu
Despas Olivier
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 BR112019015245A2 publication Critical patent/BR112019015245A2/pt

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Classifications

    • 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
    • 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
    • A61K9/08Solutions
    • 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
    • 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
    • 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)
BR112019015245A 2017-01-25 2018-01-25 composição, kit, mistura aquosa, e, método para preparação da composição. BR112019015245A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
BR112019015245A2 true BR112019015245A2 (pt) 2020-04-14

Family

ID=58462949

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019015245A BR112019015245A2 (pt) 2017-01-25 2018-01-25 composição, kit, mistura aquosa, e, método para preparação da composição.

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

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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
CA3050629A1 (en) 2018-08-02
CN110430867A (zh) 2019-11-08
EP3573598A1 (en) 2019-12-04
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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Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B350 Update of information on the portal [chapter 15.35 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICA??O DE DEVOLU??O DO PEDIDO EM FUN??O DA REVOGA??O DO ART. 229-C DA LEI N? 9.279, DE 1996, POR FOR?A DA LEI N? 14.195, DE 2021

B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 7A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2811 DE 19/11/2024.