AR114138A1 - Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante atenuado vivo y proceso para la preparación de las mismas - Google Patents

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

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Publication number
AR114138A1
AR114138A1 ARP180102954A ARP180102954A AR114138A1 AR 114138 A1 AR114138 A1 AR 114138A1 AR P180102954 A ARP180102954 A AR P180102954A AR P180102954 A ARP180102954 A AR P180102954A AR 114138 A1 AR114138 A1 AR 114138A1
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AR
Argentina
Prior art keywords
virus
live attenuated
den
viral harvest
immunogenic composition
Prior art date
Application number
ARP180102954A
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English (en)
Inventor
Sandeep Dinkar Baraskar
Rohit Bapurav Sonar
Vinit Kumar
Yeolekar Leena Ravindra
Dhere Rajeev Mhalasakant
Rajeev Mehla
Shashikant Janardan Ghodekar
Original Assignee
Serum Inst 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 Inst Of India Pvt Ltd filed Critical Serum Inst Of India Pvt Ltd
Publication of AR114138A1 publication Critical patent/AR114138A1/es

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    • 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
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    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
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    • 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
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    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Medicinal Chemistry (AREA)
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  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • General Engineering & Computer Science (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 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 los que la composición conserva las características deseadas de un virus, incluyendo la viabilidad, inmunogenicidad y estabilidad del virus. Dicha composición inmunogénica está libre de conservantes, polímeros y tensioactivos. Los métodos para fabricar dichas composiciones inmunogénicas liofilizadas estables. Reivindicación 1: Una composición inmunogénica que comprende: a) uno o más flavivirus atenuados vivos; b) uno o más carbohidratos de aproximadamente 3 a 6% (p/v); c) uno o más aminoácidos de aproximadamente 3 a 6% (p/v); en donde, la composición es susceptible de tratamientos de liofilización y la composición reconstituida conserva las características deseadas de un virus, incluyendo la viabilidad, la inmunogenicidad y la estabilidad del virus. Reivindicación 4: La composición inmunogénica según la reivindicación 1, en donde uno o más flavivirus vivos atenuados comprenden el virus del dengue (DEN), y opcionalmente comprenden una pluralidad de virus del dengue vivo atenuado (DEN) de diferentes serotipos seleccionados del grupo de DEN-1, DEN-2, DEN-3 y DEN-4. Reivindicación 10: La composición inmunogénica según la reivindicación 9, en donde al menos uno de los carbohidratos es sucrosa. Reivindicación 11: La composición inmunogénica según la reivindicación 1, en donde uno o más aminoácidos se selecciona del grupo que consiste en leucina, iso-leucina, histidina, glicina, glutamina, arginina, lisina, alanina o una combinación de las mismas. Reivindicación 29: Un método para fabricar una composición inmunogénica que comprende: a) realizar la recolección múltiple de sobrenadante que comprende al menos un serotipo de virus del dengue en MEM con solución de sal de Hanks que contiene además dextrosa, L-glutamina y bicarbonato de sodio; b) filtrar la recolección viral mediante filtración de flujo directo (DFF) a través de al menos un filtro de clarificación que tiene un tamaño de poro de entre aproximadamente 6 mm a aproximadamente 0,45 mm; c) tratar la recolección viral con una endonucleasa no especifica a 34 ± 1ºC durante al menos 2 horas; d) concentrar la recolección viral mediante filtración de flujo tangencial (TFF) utilizando una membrana con un corte de peso molecular (MWCO) de 100 kDa; e) estabilizar la recolección viral con un agente estabilizador que comprende sucrosa y glicina para formar una recolección viral estabilizada; f) esterilizar la recolección viral estabilizada por DFF a través de al menos un filtro de clarificación que tiene un tamaño de poro de entre aproximadamente 0,8 mm a aproximadamente 0,2 mm para formar una recolección viral esterilizada de virus purificado; en donde la recuperación total de virus purificados es al menos del 50%; g) opcionalmente liofilizar la recolección viral esterilizada.
ARP180102954A 2017-10-16 2018-10-12 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante atenuado vivo y proceso para la preparación de las mismas AR114138A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN201721036696 2017-10-16

Publications (1)

Publication Number Publication Date
AR114138A1 true AR114138A1 (es) 2020-07-29

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ID=66173564

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ARP180102954A AR114138A1 (es) 2017-10-16 2018-10-12 Composiciones de vacuna estables que comprenden inter alia un flavivirus recombinante atenuado vivo y proceso para la preparación de las mismas

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Country Link
US (1) US11660333B2 (es)
EP (1) EP3697897A4 (es)
JP (1) JP7261239B2 (es)
KR (1) KR20200088326A (es)
CN (1) CN111655844B (es)
AR (1) AR114138A1 (es)
AU (1) AU2018352447A1 (es)
BR (1) BR112020007513A2 (es)
CA (1) CA3079151A1 (es)
CO (1) CO2020006037A2 (es)
CR (1) CR20200212A (es)
CU (1) CU24701B1 (es)
EA (1) EA202090967A1 (es)
GE (1) GEP20237575B (es)
MX (1) MX2020004085A (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)

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Publication number Priority date Publication date Assignee Title
CA3166063A1 (en) 2013-03-15 2014-09-25 Takeda Vaccines, Inc. Compositions and methods for dengue virus chimeric constructs in vaccines
JOP20200140A1 (ar) 2017-12-07 2022-10-30 Merck Sharp & Dohme صيغ لتركيبات لقاح فيروس حُمى الضنك
WO2021119221A1 (en) * 2019-12-10 2021-06-17 Repligen Corporation Methods of preparing viral vectors
EP4100689A2 (en) * 2020-02-04 2022-12-14 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
GB2600468A (en) * 2020-10-30 2022-05-04 Excivion Ltd Adjuvant composition
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
WO2023158989A1 (en) * 2022-02-15 2023-08-24 Takeda Vaccines, Inc. Dengue vaccine batch mixing process
EP4356925A3 (en) * 2022-10-18 2024-05-01 Takeda Vaccines, Inc. Dengue vaccine formulation
WO2024118740A1 (en) * 2022-11-29 2024-06-06 Takeda Vaccines, Inc. Large-scale flaviviral vaccine production and manufacture

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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
US8785173B2 (en) * 2008-09-24 2014-07-22 Medimmune, Llc Methods for purification of viruses
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Also Published As

Publication number Publication date
US20210187092A1 (en) 2021-06-24
EP3697897A4 (en) 2022-02-23
PE20210106A1 (es) 2021-01-19
CU24701B1 (es) 2024-04-08
KR20200088326A (ko) 2020-07-22
UA127829C2 (uk) 2024-01-17
WO2019077622A1 (en) 2019-04-25
MX2020004085A (es) 2020-12-03
SG11202003408TA (en) 2020-05-28
ZA202002852B (en) 2021-03-31
PH12020550266A1 (en) 2021-03-01
GEP20237575B (en) 2023-12-25
CN111655844A (zh) 2020-09-11
JP2020537691A (ja) 2020-12-24
CR20200212A (es) 2020-07-17
CO2020006037A2 (es) 2020-08-10
TWI812650B (zh) 2023-08-21
TW201922272A (zh) 2019-06-16
AU2018352447A1 (en) 2020-06-11
CN111655844B (zh) 2024-05-24
EA202090967A1 (ru) 2020-08-12
CA3079151A1 (en) 2019-04-25
US11660333B2 (en) 2023-05-30
BR112020007513A2 (pt) 2020-10-06
JP7261239B2 (ja) 2023-04-19
SA520411768B1 (ar) 2023-12-21
EP3697897A1 (en) 2020-08-26
CU20200036A7 (es) 2021-03-11

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