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MX2020004085A - 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
MX2020004085A
MX2020004085A MX2020004085A MX2020004085A MX2020004085A MX 2020004085 A MX2020004085 A MX 2020004085A MX 2020004085 A MX2020004085 A MX 2020004085A MX 2020004085 A MX2020004085 A MX 2020004085A MX 2020004085 A MX2020004085 A MX 2020004085A
Authority
MX
Mexico
Prior art keywords
live attenuated
attenuated recombinant
inter alia
preparation
vaccine compositions
Prior art date
Application number
MX2020004085A
Other languages
English (en)
Inventor
Dhere Rajeev Mhalasakant
Yeolekar Leena Ravindra
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 MX2020004085A publication Critical patent/MX2020004085A/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
    • 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
    • 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
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • 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
    • 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
    • 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
    • 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

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)
  • Mycology (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (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 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.
MX2020004085A 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. MX2020004085A (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
MX2020004085A true MX2020004085A (es) 2020-12-03

Family

ID=66173564

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2020004085A MX2020004085A (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
JP6818548B2 (ja) 2013-03-15 2021-01-20 タケダ ワクチン, インコーポレイテッドTakeda Vaccines, Inc. ワクチンにおけるデングウイルスキメラ構築物に関する組成物および方法
UA129245C2 (uk) 2017-12-07 2025-02-26 Мерк Шарп Енд Доум Елелсі Склад вакцинної композиції від вірусу денге
US11426461B2 (en) 2018-09-05 2022-08-30 Takeda Vaccines, Inc. Methods for preventing dengue and hepatitis A
US20220340914A1 (en) * 2019-12-10 2022-10-27 Repligen Corporation Methods of preparing viral vectors
KR20220129088A (ko) * 2020-02-04 2022-09-22 리제너론 파아마슈티컬스, 인크. 동결건조 의약품의 목표 잔류 수분 함량
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
WO2023037387A2 (en) * 2021-09-08 2023-03-16 Serum Institute Of India Private Limited Freeze-dried viral combination vaccine compositions and process for preparation thereof
EP4479025B1 (en) * 2022-02-15 2026-02-04 Takeda Vaccines, Inc. Dengue vaccine batch mixing process
EP4356925B1 (en) * 2022-10-18 2025-09-10 Takeda Vaccines, Inc. Dengue vaccine formulation
CN120529951A (zh) * 2022-11-29 2025-08-22 武田疫苗股份有限公司 大规模黄病毒疫苗生产和制造
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
DK2829282T3 (en) * 2007-03-22 2018-01-02 Univ Colorado Regents Process for preparing an immunologically active adjuvant-linked 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
EP2334328A4 (en) * 2008-09-24 2012-08-29 Medimmune Llc METHOD FOR CLEANING VIRUSES
WO2010146598A2 (en) * 2008-11-07 2010-12-23 Serum Institute Of India Ltd. Stable, dried rotavirus vaccine, compositions and process for preparation thereof
EA201390812A1 (ru) * 2010-12-02 2013-11-29 Онколитикс Байотек Инк. Лиофилизированные вирусные составы
SG10201510800PA (en) 2012-01-09 2016-01-28 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
MY200888A (en) * 2015-09-30 2024-01-22 Panacea Biotec Ltd 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
WO2019077622A1 (en) 2019-04-25
UA127829C2 (uk) 2024-01-17
SG11202003408TA (en) 2020-05-28
EA202090967A1 (ru) 2020-08-12
GEP20237575B (en) 2023-12-25
AU2018352447B2 (en) 2025-04-03
GEAP202315338A (en) 2023-07-10
CR20200212A (es) 2020-07-17
EP3697897A4 (en) 2022-02-23
CN111655844B (zh) 2024-05-24
EP3697897A1 (en) 2020-08-26
KR102755215B1 (ko) 2025-01-20
PE20210106A1 (es) 2021-01-19
CN111655844A (zh) 2020-09-11
US20210187092A1 (en) 2021-06-24
ZA202002852B (en) 2021-03-31
JP7261239B2 (ja) 2023-04-19
SA520411768B1 (ar) 2023-12-21
TW201922272A (zh) 2019-06-16
CO2020006037A2 (es) 2020-08-10
CU20200036A7 (es) 2021-03-11
MY209364A (en) 2025-07-03
JP2020537691A (ja) 2020-12-24
BR112020007513A2 (pt) 2020-10-06
AU2018352447A1 (en) 2020-06-11
CU24701B1 (es) 2024-04-08
TWI812650B (zh) 2023-08-21
US11660333B2 (en) 2023-05-30
KR20200088326A (ko) 2020-07-22
AR114138A1 (es) 2020-07-29
PH12020550266A1 (en) 2021-03-01
CA3079151A1 (en) 2019-04-25

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