PE20121405A1 - Excipiente solubilizante para vacunas de virus completo inactivado - Google Patents

Excipiente solubilizante para vacunas de virus completo inactivado

Info

Publication number
PE20121405A1
PE20121405A1 PE2012000455A PE2012000455A PE20121405A1 PE 20121405 A1 PE20121405 A1 PE 20121405A1 PE 2012000455 A PE2012000455 A PE 2012000455A PE 2012000455 A PE2012000455 A PE 2012000455A PE 20121405 A1 PE20121405 A1 PE 20121405A1
Authority
PE
Peru
Prior art keywords
composition
amount
buffer
refers
mixture
Prior art date
Application number
PE2012000455A
Other languages
English (en)
Inventor
Alain Francon
Nadege Moreno
Sandrine Cigarini
Michel Chevalier
Eric Calvosa
Virginie Fabre
Original Assignee
Sanofi Pasteur
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 Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of PE20121405A1 publication Critical patent/PE20121405A1/es

Links

Classifications

    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/205Rhabdoviridae, e.g. rabies virus
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • 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
    • A61K2039/5252Virus inactivated (killed)
    • 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
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/20011Rhabdoviridae
    • C12N2760/20111Lyssavirus, e.g. rabies virus
    • C12N2760/20134Use 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

SE REFIERE A UNA COMPOSICION DE VACUNA QUE COMPRENDE: (A) UNA PREPARACION DE VIRUS INACTIVADO DE LA RABIA Y (B) UN EXCIPIENTE ESTABILIZADOR QUE COMPRENDE: i) UNA SOLUCION TAMPON TAL COMO TAMPON FOSFATO, TAMPON TRIS, TAMPON HEPES O MEZCLA DE LOS MISMOS; ii) UNA MEZCLA DE AMINOACIDOS ESENCIALES Y NO ESENCIALES TAL COMO SALES DE ARGININA O DE ACIDO GLUTAMICO EN UNA CANTIDAD ENTRE 0.5 Y 2.5 MG; iii) UN DISACARIDO TAL COMO MALTOSA; iv) UN POLIOL TAL COMO SORBITOL; v) UN AGENTE QUELANTE TAL COMO EDTA O UNA SAL DE LA MISMA EN UNA CANTIDAD ENTRE 0.01 Y 0.1 MG; vi) UREA O DERIVADO DE UREA EN UNA CANTIDAD ENTRE 0.3 Y 1.5 MG; vii) UN SURFACTANTE NO IONICO TAL COMO POLOXAMERO 188 EN UNA CANTIDAD ENTRE 0.001 Y 0.5 MG. EL PH DE LA COMPOSICION ESTA ENTRE 7.0 Y 10.0. SE REFIERE TAMBIEN A UN PROCESO DE PREPARACION. LA COMPOSICION DE VACUNA ESTA LIBRE DE CUALQUIER PROTEINA EXOGENA DE ORIGEN ANIMAL, SOLAMENTE LAS PROTEINAS VIRALES REPRESENTAN POR LO MENOS 70% DE LAS PROTEINAS TOTALES DE DICHA COMPOSICION. EL EXCIPIENTE ESTABILIZADOR DE DICHA COMPOSICION PREVIENE LA FORMACION DE AGREGADOS Y/O LA DEGRADACION ESTRUCTURAL DE LAS PARTICULAS VIRALES
PE2012000455A 2009-10-07 2010-10-07 Excipiente solubilizante para vacunas de virus completo inactivado PE20121405A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0904795 2009-10-07

Publications (1)

Publication Number Publication Date
PE20121405A1 true PE20121405A1 (es) 2012-11-02

Family

ID=42123015

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2012000455A PE20121405A1 (es) 2009-10-07 2010-10-07 Excipiente solubilizante para vacunas de virus completo inactivado

Country Status (15)

Country Link
US (2) US8557253B2 (es)
EP (2) EP3915586A1 (es)
CN (1) CN102281900B (es)
AR (2) AR078558A1 (es)
AU (1) AU2010304898B2 (es)
BR (1) BR112012008000B1 (es)
ES (1) ES2862910T3 (es)
MA (1) MA33723B1 (es)
MX (1) MX338300B (es)
PE (1) PE20121405A1 (es)
PL (1) PL2485766T3 (es)
PT (1) PT2485766T (es)
RU (1) RU2560675C2 (es)
WO (1) WO2011042663A1 (es)
ZA (1) ZA201202758B (es)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8557253B2 (en) * 2009-10-07 2013-10-15 Sanofi Pasteur Sa Stabilizing excipient for inactivated whole virus vaccine
FR2960781B1 (fr) * 2010-06-07 2013-11-22 Sanofi Pasteur Preparation d'un vaccin oral sec stabilise, compose d'un virus vivant attenue
BR112013005049A2 (pt) * 2010-09-02 2016-05-31 Sanofi Pasteur estabilizador para a preparação de uma composição vacina da pólio seca injetável
CN107050445A (zh) * 2011-05-26 2017-08-18 葛兰素史密丝克莱恩生物有限公司 灭活登革热病毒疫苗
EP3744833A1 (en) 2011-06-28 2020-12-02 Leukocare Ag Stabilisation method for viruses
US9314519B2 (en) 2012-08-21 2016-04-19 Intervet Inc. Liquid stable virus vaccines
TWI690322B (zh) * 2012-10-02 2020-04-11 法商傳斯堅公司 含病毒的調配物及其使用
US9393298B2 (en) 2013-03-15 2016-07-19 Intervet Inc. Liquid stable bovine virus vaccines
US9480739B2 (en) * 2013-03-15 2016-11-01 Intervet Inc. Bovine virus vaccines that are liquid stable
US10736840B2 (en) 2013-09-03 2020-08-11 Georgia Tech Research Corporation Thermally stable vaccine formulations and microneedles
AR097762A1 (es) 2013-09-27 2016-04-13 Intervet Int Bv Formulaciones secas de vacunas que son estables a temperatura ambiente
WO2015059284A1 (en) 2013-10-25 2015-04-30 Leukocare Ag A novel method for the production of stabile vaccines
AR099470A1 (es) * 2014-02-17 2016-07-27 Intervet Int Bv Vacunas de virus de aves de corral líquidas
TWI670085B (zh) 2014-02-19 2019-09-01 荷蘭商英特威國際公司 液體穩定之豬病毒疫苗
CN104548085B (zh) * 2014-12-09 2018-01-19 吕宏亮 一种口蹄疫全病毒颗粒疫苗组合物及其制备方法和应用
CN105816879A (zh) * 2016-03-17 2016-08-03 广州市嘉合生物技术有限公司 用于提高冻干病毒疫苗在常温下保存的效力的冻干稳定剂
WO2018050873A1 (en) * 2016-09-16 2018-03-22 Leukocare Ag A novel method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation
CN109952372A (zh) 2016-09-16 2019-06-28 白血球保健股份有限公司 获得有效用于疫苗接种或基因治疗的基于病毒载体的组合物的新方法
US20190256551A1 (en) * 2016-09-16 2019-08-22 Leukocare Ag A novel method of producing a liquid biopharmaceutical drug product
GB201815011D0 (en) * 2018-09-14 2018-10-31 Adaptimmune Ltd Viral assay method
US20220193222A1 (en) * 2018-11-30 2022-06-23 Vaccine Stabilization Institute Viral formulations containing amino acids
US20220401554A1 (en) * 2019-11-07 2022-12-22 Cornell University Use of membrane inhibitors to enhance vaccine development against enveloped viruses
CN112245394B (zh) * 2020-10-21 2022-10-11 成都柏奥特克生物科技股份有限公司 一种疫苗保护剂
WO2023023371A1 (en) * 2021-08-20 2023-02-23 Vaccine Stabilization Institute Formulations containing amino acids for stabilizing lipid enveloped viral and non-viral vectors
CN114377127B (zh) * 2022-01-25 2023-10-24 天津市中升挑战生物科技有限公司 一种三联卵黄抗体制剂及其制备方法和应用

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FR952310A (fr) 1946-09-20 1949-11-15 Ford Transmission par accouplement hydraulique jumelé
JPS577423B2 (es) 1972-12-29 1982-02-10
FR2505657A1 (fr) 1981-05-13 1982-11-19 Pasteur Institut Perfectionnements apportes aux agents de stabilisation de virus vivants pour la preparation de vaccins, et vaccins stabilises contenant lesdits agents de stabilisation
US5565209A (en) * 1987-03-17 1996-10-15 Akzo Nobel N.V. Adjuvant mixture
FR2633518B1 (fr) 1988-06-30 1991-03-22 Merieux Inst Procede de stabilisation des vaccins et associations de vaccins a virus attenues conserves sous forme lyophilisee, et compositions obtenues
FR2737730B1 (fr) 1995-08-10 1997-09-05 Pasteur Merieux Serums Vacc Procede de purification de virus par chromatographie
FR2742756B1 (fr) 1995-12-22 1998-04-03 Pasteur Merieux Serums Vacc Stabilisants pour vaccins vivants, vaccins les contenant et procedes pour leur preparation
FR2801900B1 (fr) 1999-12-03 2004-02-27 Pasteur Merieux Serums Vacc Methode de production de cellules animales adherentes
AU2005227320B2 (en) 2004-03-22 2010-06-24 Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services, National Insitutes Of Health Cellular and viral inactivation
CN101095950B (zh) 2006-06-30 2011-01-26 辽宁成大生物股份有限公司 一种稳定的人用狂犬病疫苗冻干制剂及其制备
GB0615312D0 (en) * 2006-08-02 2006-09-13 Univ Dundee Protein Solubilisation
EP2143440A1 (fr) 2008-07-09 2010-01-13 Sanofi Pasteur Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués
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US8557253B2 (en) * 2009-10-07 2013-10-15 Sanofi Pasteur Sa Stabilizing excipient for inactivated whole virus vaccine

Also Published As

Publication number Publication date
US20140037684A1 (en) 2014-02-06
US9028839B2 (en) 2015-05-12
ZA201202758B (en) 2013-06-26
US8557253B2 (en) 2013-10-15
PT2485766T (pt) 2021-03-18
AU2010304898A1 (en) 2012-05-17
PL2485766T3 (pl) 2021-09-06
WO2011042663A1 (fr) 2011-04-14
CN102281900B (zh) 2013-07-03
RU2560675C2 (ru) 2015-08-20
EP2485766A1 (fr) 2012-08-15
EP3915586A1 (fr) 2021-12-01
RU2012118386A (ru) 2013-11-20
AR078558A1 (es) 2011-11-16
BR112012008000A2 (pt) 2016-03-29
MA33723B1 (fr) 2012-11-01
BR112012008000B1 (pt) 2021-07-13
MX2012003935A (es) 2012-05-08
EP2485766B1 (fr) 2020-12-30
AU2010304898B2 (en) 2015-03-19
ES2862910T3 (es) 2021-10-08
US20110081380A1 (en) 2011-04-07
AR118273A2 (es) 2021-09-22
CN102281900A (zh) 2011-12-14
MX338300B (es) 2016-04-11

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