CU20200036A7 - Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparación de las mismas - Google Patents

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

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Publication number
CU20200036A7
CU20200036A7 CU2020000036A CU20200036A CU20200036A7 CU 20200036 A7 CU20200036 A7 CU 20200036A7 CU 2020000036 A CU2020000036 A CU 2020000036A CU 20200036 A CU20200036 A CU 20200036A CU 20200036 A7 CU20200036 A7 CU 20200036A7
Authority
CU
Cuba
Prior art keywords
inter alia
attenuated
preparation
same
compositions including
Prior art date
Application number
CU2020000036A
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English (en)
Other versions
CU24701B1 (es
Inventor
Sandeep Dinkar Baraskar
Rajeev Mhalasakant Dhere
Shashikant Janardan Ghodekar
Vinit Kumar
Rajeev Mehla
Rohit Bapurav Sonar
Leena Ravindra Yeolekar
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.)
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Publication date
Application filed by Serum Institute Of India Pvt Ltd filed Critical Serum Institute Of India Pvt Ltd
Publication of CU20200036A7 publication Critical patent/CU20200036A7/es
Publication of CU24701B1 publication Critical patent/CU24701B1/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • 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
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/08RNA viruses
    • C07K14/18Togaviridae; Flaviviridae
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    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04Inactivation or attenuation; Producing viral sub-units
    • C12N7/06Inactivation or attenuation by chemical treatment
    • 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
    • A61K2039/525Virus
    • A61K2039/5254Virus avirulent or attenuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55561CpG containing adjuvants; Oligonucleotide containing adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55572Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55577Saponins; Quil A; QS21; ISCOMS
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55583Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24111Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (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

<p>Composiciones inmunogénicas liofilizadas estables que comprenden, entre otros, flavivirus vivos atenuados recombinantes, más preferiblemente virus del dengue recombinantes vivos atenuados, al menos un hidrato de carbono, al menos un aminoácido, y que son particularmente susceptibles de tratamientos de liofilización rápida en donde, la composición conserva las características deseadas de un virus, que incluye la viabilidad, inmunogenicidad y estabilidad del virus. La mencionada composición inmunogénica está libre de conservantes, polímeros y surfactantes. Los métodos para fabricar las mencionadas composiciones inmunogénicas liofilizadas estables. </p>
CU2020000036A 2017-10-16 2018-10-10 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparación de las mismas CU24701B1 (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 (2)

Publication Number Publication Date
CU20200036A7 true CU20200036A7 (es) 2021-03-11
CU24701B1 CU24701B1 (es) 2024-04-08

Family

ID=66173564

Family Applications (1)

Application Number Title Priority Date Filing Date
CU2020000036A CU24701B1 (es) 2017-10-16 2018-10-10 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante vivo atenuado y proceso para la preparación de las mismas

Country Status (24)

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) GEP20237575B (es)
MX (1) MX2020004085A (es)
MY (1) MY209364A (es)
PE (1) PE20210106A1 (es)
PH (1) PH12020550266A1 (es)
PY (1) PY1889910A (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
CA2903231C (en) 2013-03-15 2025-12-09 The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Compositions and methods for dengue virus chimeric constructs in vaccines
JP7042341B2 (ja) 2017-12-07 2022-03-25 メルク・シャープ・アンド・ドーム・コーポレーション デングウイルスワクチン組成物の製剤
US11426461B2 (en) 2018-09-05 2022-08-30 Takeda Vaccines, Inc. Methods for preventing dengue and hepatitis A
EP4072582A4 (en) * 2019-12-10 2023-05-24 Repligen Corporation PROCESS FOR PREPARING VIRAL VECTORS
AU2021217370A1 (en) * 2020-02-04 2022-08-18 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
WO2023158989A1 (en) * 2022-02-15 2023-08-24 Takeda Vaccines, Inc. Dengue vaccine batch mixing process
JP2025535345A (ja) * 2022-10-18 2025-10-24 タケダ ワクチン,インコーポレイテッド デング熱ワクチン製剤
EP4626574A1 (en) * 2022-11-29 2025-10-08 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)

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US8444991B2 (en) * 2007-03-22 2013-05-21 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
CN102215865B (zh) * 2008-09-24 2013-10-30 米迪缪尼有限公司 病毒纯化方法
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
ES2630012T3 (es) * 2010-12-02 2017-08-17 Oncolytics Biotech Inc. Formulaciones virales liofilizadas
US20150030565A1 (en) * 2012-01-09 2015-01-29 Sanofi Pasteur Biologics, Llc Purification of flaviviruses
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Also Published As

Publication number Publication date
CN111655844B (zh) 2024-05-24
TW201922272A (zh) 2019-06-16
CO2020006037A2 (es) 2020-08-10
US11660333B2 (en) 2023-05-30
CR20200212A (es) 2020-07-17
BR112020007513A2 (pt) 2020-10-06
CN111655844A (zh) 2020-09-11
AU2018352447A1 (en) 2020-06-11
GEP20237575B (en) 2023-12-25
ZA202002852B (en) 2021-03-31
EP3697897A1 (en) 2020-08-26
GEAP202315338A (en) 2023-07-10
AU2018352447B2 (en) 2025-04-03
MX2020004085A (es) 2020-12-03
EA202090967A1 (ru) 2020-08-12
KR20200088326A (ko) 2020-07-22
JP2020537691A (ja) 2020-12-24
EP3697897A4 (en) 2022-02-23
CU24701B1 (es) 2024-04-08
WO2019077622A1 (en) 2019-04-25
JP7261239B2 (ja) 2023-04-19
PY1889910A (es) 2020-04-17
PE20210106A1 (es) 2021-01-19
CA3079151A1 (en) 2019-04-25
US20210187092A1 (en) 2021-06-24
KR102755215B1 (ko) 2025-01-20
SA520411768B1 (ar) 2023-12-21
UA127829C2 (uk) 2024-01-17
SG11202003408TA (en) 2020-05-28
TWI812650B (zh) 2023-08-21
MY209364A (en) 2025-07-03
PH12020550266A1 (en) 2021-03-01
AR114138A1 (es) 2020-07-29

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