CO2023002823A2 - Vacunas vivas liofilizadas de bordetella - Google Patents

Vacunas vivas liofilizadas de bordetella

Info

Publication number
CO2023002823A2
CO2023002823A2 CONC2023/0002823A CO2023002823A CO2023002823A2 CO 2023002823 A2 CO2023002823 A2 CO 2023002823A2 CO 2023002823 A CO2023002823 A CO 2023002823A CO 2023002823 A2 CO2023002823 A2 CO 2023002823A2
Authority
CO
Colombia
Prior art keywords
bordetella
freeze
bordetella bacteria
buffer
lyophilization
Prior art date
Application number
CONC2023/0002823A
Other languages
English (en)
Inventor
Marcel Thalen
Original Assignee
Iliad Biotechnologies Llc
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 Iliad Biotechnologies Llc filed Critical Iliad Biotechnologies Llc
Publication of CO2023002823A2 publication Critical patent/CO2023002823A2/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/099Bordetella
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/14Particulate 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
    • 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
    • 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
    • C12N1/00Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/04Preserving or maintaining viable microorganisms
    • 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
    • C12N1/00Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20Bacteria; Culture media therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/522Bacterial cells; Fungal cells; Protozoal cells avirulent or attenuated
    • 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
    • A61K9/0043Nose
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12RINDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
    • C12R2001/00Microorganisms ; Processes using microorganisms
    • C12R2001/01Bacteria or Actinomycetales ; using bacteria or Actinomycetales

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pulmonology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

Las formulaciones de bacterias Bordetella liofilizadas que son estables durante al menos dos años cuando se almacenan a temperaturas entre -20° y 22.5°C, y que presentan una viabilidad y potencia bacterianas suficientes para ser utilizadas como vacuna viva se fabrican recogiendo bacterias Bordetella de un cultivo a una DO600 entre 0.4 y 1.6; mezclando las bacterias Bordetella recogidas con un tampón de liofilización que comprende entre un 5-65% en peso de azúcar crioprotector y que tiene una temperatura entre 2-35°C, en el que la proporción de bacterias Bordetella recogidas y el tampón de liofilización está entre 5:1 y 1:5 en volumen; liofilizando la mezcla de bacterias Bordetella y el tampón de liofilización; en el que el tiempo de retención entre las etapas de recogida y liofilización es inferior a 48 horas; y recogiendo las bacterias Bordetella liofilizadas.
CONC2023/0002823A 2020-08-14 2023-03-07 Vacunas vivas liofilizadas de bordetella CO2023002823A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063066020P 2020-08-14 2020-08-14
PCT/US2021/046055 WO2022036298A1 (en) 2020-08-14 2021-08-15 Lyophilized live bordetella vaccines

Publications (1)

Publication Number Publication Date
CO2023002823A2 true CO2023002823A2 (es) 2023-03-27

Family

ID=80247370

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2023/0002823A CO2023002823A2 (es) 2020-08-14 2023-03-07 Vacunas vivas liofilizadas de bordetella

Country Status (12)

Country Link
US (1) US20230173053A1 (es)
EP (1) EP4196155A1 (es)
JP (1) JP2023540453A (es)
KR (1) KR20230051186A (es)
CN (1) CN116322756A (es)
AU (1) AU2021325149A1 (es)
BR (1) BR112023002549A2 (es)
CA (1) CA3187934A1 (es)
CL (1) CL2023000451A1 (es)
CO (1) CO2023002823A2 (es)
MX (1) MX2023001905A (es)
WO (1) WO2022036298A1 (es)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2215033C2 (ru) * 2001-06-27 2003-10-27 Научно-исследовательский институт микробиологии МО РФ Способ получения концентрата микробных клеток в производстве чумных вакцин
RU2709657C2 (ru) * 2017-08-07 2019-12-19 федеральное государственное бюджетное учреждение "Национальный исследовательский центр эпидемиологии и микробиологии имени почетного академика Н.Ф. Гамалеи" Министерства здравоохранения Российской Федерации (ФГБУ "НИЦЭМ им. Н.Ф. Гамалеи" Минздрава России) Способ лиофильного высушивания аттенуированных бактерий B. pertussis, аттенуированная бактерия B. pertussis, штамм аттенуированных бактерий B. Pertussis, вакцина, лиофилизированный вакцинный препарат

Also Published As

Publication number Publication date
JP2023540453A (ja) 2023-09-25
BR112023002549A2 (pt) 2023-03-07
AU2021325149A1 (en) 2023-03-02
CN116322756A (zh) 2023-06-23
CA3187934A1 (en) 2022-02-17
KR20230051186A (ko) 2023-04-17
EP4196155A1 (en) 2023-06-21
US20230173053A1 (en) 2023-06-08
CL2023000451A1 (es) 2023-10-20
WO2022036298A1 (en) 2022-02-17
MX2023001905A (es) 2023-03-13

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