AU2018302767B2 - An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof - Google Patents

An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof Download PDF

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Publication number
AU2018302767B2
AU2018302767B2 AU2018302767A AU2018302767A AU2018302767B2 AU 2018302767 B2 AU2018302767 B2 AU 2018302767B2 AU 2018302767 A AU2018302767 A AU 2018302767A AU 2018302767 A AU2018302767 A AU 2018302767A AU 2018302767 B2 AU2018302767 B2 AU 2018302767B2
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AU2018302767A1 (en
Inventor
Manohar Doddapaneni
Kumar Rakesh
Hitt Jyoti SHARMA
Inder Jit SHARMA
Anil Vyankatrao Shitole
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Serum Institute of India Pvt Ltd
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Serum Institute of India Pvt Ltd
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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
    • 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
    • A61K39/0016—Combination vaccines based on diphtheria-tetanus-pertussis
    • A61K39/0018—Combination vaccines based on acellular diphtheria-tetanus-pertussis
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/099—Bordetella
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/102—Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/125—Picornaviridae, e.g. calicivirus
    • A61K39/13—Poliovirus
    • 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
    • A61K39/29—Hepatitis virus
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K2039/5252—Virus inactivated (killed)
    • 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
    • A61K2039/70—Multivalent vaccine
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
    • 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
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • 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
    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • C12N2770/32011—Picornaviridae
    • C12N2770/32611—Poliovirus
    • C12N2770/32634—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)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
AU2018302767A 2017-07-18 2018-07-13 An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof Active AU2018302767B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201721025513 2017-07-18
IN201721025513 2017-07-18
PCT/IB2018/055180 WO2019016654A1 (en) 2017-07-18 2018-07-13 IMMUNOGENIC COMPOSITION WITH IMPROVED STABILITY, ENHANCED IMMUNOGENICITY, AND LESS REACTOGENICITY, AND PREPARATION METHOD THEREOF

Publications (2)

Publication Number Publication Date
AU2018302767A1 AU2018302767A1 (en) 2020-03-05
AU2018302767B2 true AU2018302767B2 (en) 2025-04-10

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AU2018302767A Active AU2018302767B2 (en) 2017-07-18 2018-07-13 An immunogenic composition having improved stability, enhanced immunogenicity and reduced reactogenicity and process for preparation thereof

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US (1) US11179453B2 (enExample)
EP (1) EP3655024A1 (enExample)
JP (1) JP7404226B2 (enExample)
KR (1) KR102657910B1 (enExample)
CN (1) CN111032078A (enExample)
AU (1) AU2018302767B2 (enExample)
BR (1) BR112020000999A2 (enExample)
CA (1) CA3070039A1 (enExample)
CO (1) CO2020001765A2 (enExample)
EA (1) EA202090316A1 (enExample)
GE (1) GEP20227386B (enExample)
JO (1) JOP20180069B1 (enExample)
MX (1) MX2020000441A (enExample)
PE (1) PE20201443A1 (enExample)
PH (1) PH12020500133A1 (enExample)
SG (1) SG11202000224SA (enExample)
TW (1) TWI786153B (enExample)
UA (1) UA128204C2 (enExample)
UY (1) UY37811A (enExample)
WO (1) WO2019016654A1 (enExample)
ZA (1) ZA202000889B (enExample)

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KR101359953B1 (ko) * 2005-06-27 2014-02-21 글락소스미스클라인 바이오로지칼즈 에스.에이. 면역원성 조성물
AU2007224734C1 (en) 2006-03-10 2016-07-14 Institut National De La Sante Et De La Recherche Medicale (Inserm) Live attenuated Bordetella strains as a single dose vaccine against whooping cough
CN102448490B (zh) 2009-04-28 2015-05-13 国家健康与医学研究院 用于预防或治疗过敏原引起的气道疾病的疫苗
EP3697439A1 (en) * 2017-10-18 2020-08-26 Institut Pasteur de Lille Bordetella strains expressing serotype 3 fimbriae
JOP20190242A1 (ar) 2018-10-12 2020-04-12 Serum Institute Of India Pvt Ltd تركيبة لقاح توليفي تشمل فيروس شلل الأطفال ذو جرعة مخفّضة خاملة التنشيط وطريقة لتحضيرها
WO2020165920A1 (en) * 2019-02-12 2020-08-20 Biological E Limited Multivalent vaccine composition
CN112138155B (zh) * 2019-06-28 2022-04-12 怡道生物科技(苏州)有限公司 一种复合佐剂系统及制备该佐剂的方法
JOP20200214A1 (ar) 2019-09-03 2021-03-03 Serum Institute Of India Pvt Ltd تركيبات مولدة للمناعة ضد الأمراض المعوية وطرق لتحضيرها
EP3988290A1 (en) 2020-10-23 2022-04-27 Carl Zeiss Vision International GmbH Method for manufacturing a spectacle lens
EP3988288A1 (en) 2020-10-23 2022-04-27 Carl Zeiss Vision International GmbH Method of manufacturing a spectacle lens
EP3988289A1 (en) 2020-10-23 2022-04-27 Carl Zeiss Vision International GmbH Method of manufacturing a spectacle lens
WO2022114921A1 (ko) * 2020-11-30 2022-06-02 주식회사 엘지화학 알루미늄 부형제를 이용하여 다가 혼합백신 내 백일해 균 유래 엔도톡신 제거 방법
MY208608A (en) * 2021-04-20 2025-05-20 Km Biologics Co Ltd Liquid sextuple vaccine composition
CN120826235A (zh) * 2023-03-16 2025-10-21 艾芬尼维克斯公司 免疫原性组合物
CN119799602A (zh) * 2025-03-17 2025-04-11 艾美坚持生物制药有限公司 一种破伤风梭状芽胞杆菌发酵培养基及培养方法

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MX2020000441A (es) 2020-08-17
KR102657910B1 (ko) 2024-04-18
US20200206331A1 (en) 2020-07-02
UA128204C2 (uk) 2024-05-08
JOP20180069A1 (ar) 2019-01-18
JP7404226B2 (ja) 2023-12-25
SG11202000224SA (en) 2020-02-27
PH12020500133A1 (en) 2021-02-08
UY37811A (es) 2019-01-02
PE20201443A1 (es) 2020-12-10
ZA202000889B (en) 2021-06-30
KR20200042470A (ko) 2020-04-23
TWI786153B (zh) 2022-12-11
TW201919690A (zh) 2019-06-01
CO2020001765A2 (es) 2020-05-29
JP2020527571A (ja) 2020-09-10
US11179453B2 (en) 2021-11-23
CN111032078A (zh) 2020-04-17
JOP20180069B1 (ar) 2022-09-15
GEP20227386B (en) 2022-06-10
EA202090316A1 (ru) 2020-12-08
WO2019016654A1 (en) 2019-01-24
CA3070039A1 (en) 2019-01-24
EP3655024A1 (en) 2020-05-27
BR112020000999A2 (pt) 2020-07-14
AU2018302767A1 (en) 2020-03-05

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