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PE20210106A1 - Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparacion de las mismas - Google Patents

Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparacion de las mismas

Info

Publication number
PE20210106A1
PE20210106A1 PE2020000644A PE2020000644A PE20210106A1 PE 20210106 A1 PE20210106 A1 PE 20210106A1 PE 2020000644 A PE2020000644 A PE 2020000644A PE 2020000644 A PE2020000644 A PE 2020000644A PE 20210106 A1 PE20210106 A1 PE 20210106A1
Authority
PE
Peru
Prior art keywords
live attenuated
inter alia
preparation
same
vaccine compositions
Prior art date
Application number
PE2020000644A
Other languages
English (en)
Inventor
Rajeev Mhalasakant Dhere
Leena Ravindra Yeolekar
Vinit Kumar
Rohit Bapurav Sonar
Sandeep Dinkar Baraskar
Rajeev Mehla
Shashikant Janardan Ghodekar
Original Assignee
Serum Institute Of India Pvt Ltd
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 Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Pvt Ltd
Publication of PE20210106A1 publication Critical patent/PE20210106A1/es

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Classifications

    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/08—RNA viruses
    • C07K14/18—Togaviridae; Flaviviridae
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04—Inactivation or attenuation; Producing viral sub-units
    • C12N7/06—Inactivation or attenuation by chemical treatment
    • 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
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • 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
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/55561—CpG containing adjuvants; Oligonucleotide containing adjuvants
    • 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
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • 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
    • A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • 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
    • A61K2039/55577—Saponins; Quil A; QS21; ISCOMS
    • 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
    • A61K2039/55583—Polysaccharides
    • 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
    • A61K2039/70—Multivalent vaccine
    • 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
    • C12N2770/24011—Flaviviridae
    • C12N2770/24111—Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

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

Abstract

Composiciones inmunogenicas liofilizadas estables que comprenden, entre otros, flavivirus vivos atenuados recombinantes, mas preferiblemente virus del dengue recombinantes vivos atenuados, al menos un hidrato de carbono, al menos un aminoacido, y que son particularmente susceptibles de tratamientos de liofilizacion rapida en donde, la composicion conserva las caracteristicas deseadas de un virus, que incluye la viabilidad, inmunogenicidad y estabilidad del virus. La mencionada composicion inmunogenica esta libre de conservantes, polimeros y surfactantes. Los metodos para fabricar las mencionadas composiciones inmunogenicas liofilizadas estables
PE2020000644A 2017-10-16 2018-10-10 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparacion de las mismas PE20210106A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201721036696 2017-10-16
PCT/IN2018/050645 WO2019077622A1 (en) 2017-10-16 2018-10-10 STABLE VACCINE COMPOSITIONS COMPRISING, BOTH, A LIVING RECOMBINANT FLAVIVUS ATTENUATED AND PROCESS FOR PREPARING THE SAME

Publications (1)

Publication Number Publication Date
PE20210106A1 true PE20210106A1 (es) 2021-01-19

Family

ID=66173564

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2020000644A PE20210106A1 (es) 2017-10-16 2018-10-10 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparacion de las mismas

Country Status (23)

Country Link
US (1) US11660333B2 (es)
EP (1) EP3697897A4 (es)
JP (1) JP7261239B2 (es)
KR (1) KR102755215B1 (es)
CN (1) CN111655844B (es)
AR (1) AR114138A1 (es)
AU (1) AU2018352447B2 (es)
CA (1) CA3079151A1 (es)
CO (1) CO2020006037A2 (es)
CR (1) CR20200212A (es)
CU (1) CU24701B1 (es)
EA (1) EA202090967A1 (es)
GE (2) GEAP202315338A (es)
MX (1) MX2020004085A (es)
MY (1) MY209364A (es)
PE (1) PE20210106A1 (es)
PH (1) PH12020550266A1 (es)
SA (1) SA520411768B1 (es)
SG (1) SG11202003408TA (es)
TW (1) TWI812650B (es)
UA (1) UA127829C2 (es)
WO (1) WO2019077622A1 (es)
ZA (1) ZA202002852B (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX374519B (es) 2013-03-15 2025-03-06 Us Gov Health & Human Services Composiciones y metodos de construcciones quimericas del virus del dengue en vacunas.
PH12020550734A1 (en) 2017-12-07 2021-04-19 Merck Sharp & Dohme Llc Formulations of dengue virus vaccine compositions
US11426461B2 (en) 2018-09-05 2022-08-30 Takeda Vaccines, Inc. Methods for preventing dengue and hepatitis A
JP2023501693A (ja) * 2019-12-10 2023-01-18 レプリゲン・コーポレーション ウイルスベクターの調製方法
WO2021158759A2 (en) * 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
GB2600468A (en) * 2020-10-30 2022-05-04 Excivion Ltd Adjuvant composition
US12318439B2 (en) * 2021-05-09 2025-06-03 Board Of Regents, The University Of Texas System Attenuating viral mutations in protein genes
US20250057939A1 (en) * 2021-09-08 2025-02-20 Serum Institute Of India Private Limited Freeze-dried viral combination vaccine compositions and process for preparation thereof
JP2025507397A (ja) * 2022-02-15 2025-03-18 タケダ ワクチン，インコーポレイテッド デング熱ワクチンバッチ混合プロセス
EP4356925B1 (en) * 2022-10-18 2025-09-10 Takeda Vaccines, Inc. Dengue vaccine formulation
WO2024118740A1 (en) * 2022-11-29 2024-06-06 Takeda Vaccines, Inc. Large-scale flaviviral vaccine production and manufacture
WO2025027616A1 (en) * 2023-08-01 2025-02-06 Serum Institute Of India Private Limited Freeze-dried viral vaccine compositions and method of manufacturing thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2131857B1 (en) 2007-03-22 2015-07-29 The Regents of the University of Colorado, a body corporate Method of preparing an immunologically-active adjuvant-bound dried vaccine composition
EP2143440A1 (fr) * 2008-07-09 2010-01-13 Sanofi Pasteur Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués
CA2738024A1 (en) * 2008-09-24 2010-04-01 Medimmune, Llc Methods for purification of viruses
CN102202688B (zh) 2008-11-07 2017-04-12 印度血清研究所私人有限公司 稳定、干燥的轮状病毒疫苗、其组合物和制备其的方法
EA201390812A1 (ru) * 2010-12-02 2013-11-29 Онколитикс Байотек Инк. Лиофилизированные вирусные составы
WO2013106337A1 (en) * 2012-01-09 2013-07-18 Sanofi Pasteur Biologics, Llc Purification of flaviviruses
US10004795B2 (en) * 2015-09-08 2018-06-26 Fundacao Butantan Process for preparing an attenuated tetravalent dengue vaccine
WO2017056101A1 (en) 2015-09-30 2017-04-06 Panacea Biotec Limited Stable live attenuated recombinant dengue vaccine
US10751408B2 (en) * 2016-02-23 2020-08-25 The Regents Of The University Of Colorado, A Body Corporate Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens

Also Published As

Publication number Publication date
KR102755215B1 (ko) 2025-01-20
SA520411768B1 (ar) 2023-12-21
AU2018352447B2 (en) 2025-04-03
AU2018352447A1 (en) 2020-06-11
GEAP202315338A (en) 2023-07-10
CN111655844A (zh) 2020-09-11
CR20200212A (es) 2020-07-17
US11660333B2 (en) 2023-05-30
EP3697897A4 (en) 2022-02-23
MY209364A (en) 2025-07-03
CU20200036A7 (es) 2021-03-11
UA127829C2 (uk) 2024-01-17
CU24701B1 (es) 2024-04-08
US20210187092A1 (en) 2021-06-24
KR20200088326A (ko) 2020-07-22
BR112020007513A2 (pt) 2020-10-06
EP3697897A1 (en) 2020-08-26
JP2020537691A (ja) 2020-12-24
GEP20237575B (en) 2023-12-25
PH12020550266A1 (en) 2021-03-01
JP7261239B2 (ja) 2023-04-19
SG11202003408TA (en) 2020-05-28
CN111655844B (zh) 2024-05-24
MX2020004085A (es) 2020-12-03
CA3079151A1 (en) 2019-04-25
CO2020006037A2 (es) 2020-08-10
WO2019077622A1 (en) 2019-04-25
EA202090967A1 (ru) 2020-08-12
TW201922272A (zh) 2019-06-16
ZA202002852B (en) 2021-03-31
AR114138A1 (es) 2020-07-29
TWI812650B (zh) 2023-08-21

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