CN104302315B - 免疫原性组合物及其制备方法 - Google Patents

免疫原性组合物及其制备方法 Download PDF

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Publication number
CN104302315B
CN104302315B CN201380017781.9A CN201380017781A CN104302315B CN 104302315 B CN104302315 B CN 104302315B CN 201380017781 A CN201380017781 A CN 201380017781A CN 104302315 B CN104302315 B CN 104302315B
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China
Prior art keywords
conjugate
serogroup
meningitidis
neisseria meningitidis
polysaccharide
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CN201380017781.9A
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Chinese (zh)
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CN104302315A (zh
Inventor
苏布哈什·维纳亚克·卡普雷
萨姆哈吉·尚卡尔·皮萨尔
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Serum Institute of India Pvt Ltd
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Serum Institute of India Pvt Ltd
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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
    • A61K39/02Bacterial antigens
    • A61K39/095Neisseria
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/62Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
    • A61K2039/627Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier characterised by the linker
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201380017781.9A 2012-01-30 2013-01-29 免疫原性组合物及其制备方法 Active CN104302315B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN281MU2012 2012-01-30
IN281/MUM/2012 2012-01-30
PCT/IB2013/050739 WO2013114268A1 (en) 2012-01-30 2013-01-29 Immunogenic composition

Publications (2)

Publication Number Publication Date
CN104302315A CN104302315A (zh) 2015-01-21
CN104302315B true CN104302315B (zh) 2018-02-06

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CN201380017781.9A Active CN104302315B (zh) 2012-01-30 2013-01-29 免疫原性组合物及其制备方法

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US (1) US9198977B2 (https=)
EP (1) EP2809349B1 (https=)
JP (1) JP6042455B2 (https=)
KR (1) KR101897317B1 (https=)
CN (1) CN104302315B (https=)
BR (1) BR112014018815B1 (https=)
CA (1) CA2863178C (https=)
DK (1) DK2809349T3 (https=)
ES (1) ES2707294T3 (https=)
HU (1) HUE040914T4 (https=)
MX (1) MX354103B (https=)
PT (1) PT2809349T (https=)
RU (1) RU2634405C2 (https=)
SG (1) SG11201404447WA (https=)
SI (1) SI2809349T1 (https=)
TR (1) TR201900778T4 (https=)
WO (1) WO2013114268A1 (https=)

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US8398983B2 (en) 2005-06-27 2013-03-19 Glaxosmithkline Biologicals, S.A. Immunogenic composition
RU2627156C2 (ru) * 2012-11-21 2017-08-03 Серум Инститьют Оф Индия Прайват Лтд. Высокоэффективный способ получения бактериального полисахарида, получение конъюгата на его основе и иммуногенная композиция
EP3035957B1 (en) 2013-08-24 2019-11-20 Bharat Biotech International Limited A bacterial vaccine and methods for manufacture thereof
EP2921856B1 (en) 2014-03-18 2016-09-14 Serum Institute Of India Private Limited A quantitative assay for 4-pyrrolidinopyridine (4-ppy) in polysaccharide-protein conjugate vaccines
PE20180460A1 (es) 2015-06-08 2018-03-06 Serum Inst Of India Private Ltd Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos
WO2017006349A1 (en) * 2015-07-04 2017-01-12 Bharat Biotech International Limited Polysaccharide vaccine formulations and processes for industrial production of bacterial polysaccharides
KR102428253B1 (ko) * 2016-03-15 2022-08-02 엠에스디 웰컴 트러스트 힐레맨 랩스 피브이티. 리미티드 신규한 다당류-단백질 접합체 및 이의 제조방법
CN106110316A (zh) * 2016-06-27 2016-11-16 北京智飞绿竹生物制药有限公司 一种肺炎球菌结合物组合疫苗的制备方法
KR102906912B1 (ko) * 2016-09-02 2026-01-05 사노피 파스퇴르 인크 네이세리아 메닌기티디스 백신
CN106397537B (zh) * 2016-10-13 2020-01-07 李红臣 一种高效快速的多糖蛋白结合疫苗纯化分析方法
JP7319929B2 (ja) * 2017-05-05 2023-08-02 セラム インスティテュート オブ インディア プライベート リミティド 細菌性莢膜多糖ベース調製物からの不純物の除去方法
JP2020525495A (ja) * 2017-06-27 2020-08-27 エムエスディー ウェルカム トラスト ヒルマン ラボラトリーズ プライベート リミテッドMsd Wellcome Trust Hilleman Laboratories Pvt.Ltd. 新規の多価多糖類・タンパク質のコンジュゲートワクチン組成物及びその製剤
WO2019145981A1 (en) * 2018-01-29 2019-08-01 Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd. Novel meningococcal vaccine composition and process thereof
WO2019198096A1 (en) * 2018-04-11 2019-10-17 Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd. Tetravalent meningococcal vaccine composition and process to prepare thereof
JOP20200214A1 (ar) 2019-09-03 2021-03-03 Serum Institute Of India Pvt Ltd تركيبات مولدة للمناعة ضد الأمراض المعوية وطرق لتحضيرها
EP4034157A1 (en) 2019-09-27 2022-08-03 Pfizer Inc. Neisseria meningitidis compositions and methods thereof
WO2022035816A1 (en) 2020-08-10 2022-02-17 Inventprise, Llc Multivalent pneumococcal glycoconjugate vaccines containing emerging serotype 24f
CN118078981A (zh) * 2024-04-26 2024-05-28 成都康华生物制品股份有限公司 一种基于双蛋白载体的五价脑膜炎球菌多糖结合疫苗的制备方法及其产品

Citations (2)

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CN101208101A (zh) * 2005-06-27 2008-06-25 葛兰素史密丝克莱恩生物有限公司 免疫原性组合物
WO2008102173A1 (en) * 2007-02-21 2008-08-28 Health Protection Agency Compositions comprising polysaccharide conjugates and their use as vaccines

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FR2763244B1 (fr) * 1997-05-14 2003-08-01 Pasteur Merieux Serums Vacc Composition vaccinale multivalente a porteur mixte
HU227893B1 (en) * 2000-06-29 2012-05-29 Glaxosmithkline Biolog Sa Vaccine compositions
GB0115176D0 (en) * 2001-06-20 2001-08-15 Chiron Spa Capular polysaccharide solubilisation and combination vaccines
GB0130215D0 (en) * 2001-12-18 2002-02-06 Glaxosmithkline Biolog Sa Vaccine
CN103357002A (zh) * 2003-10-02 2013-10-23 诺华疫苗和诊断有限公司 多种脑膜炎球菌血清群的液体疫苗
US8398983B2 (en) * 2005-06-27 2013-03-19 Glaxosmithkline Biologicals, S.A. Immunogenic composition
NZ598367A (en) * 2005-09-01 2013-10-25 Novartis Vaccines & Diagnostic Multiple vaccination including serogroup C meningococcus
PL1973564T3 (pl) * 2005-12-22 2017-04-28 Glaxosmithkline Biologicals S.A. Szczepionki zawierające koniugaty polisacharydu otoczkowego streptococcus pneumoniae
MX2012006961A (es) * 2009-12-17 2012-10-03 Fina Biosolutions Llc Reactivos quimicos para la activacion de polisacaridos en la preparacion de vacunas conjugadas.
WO2013174832A1 (en) * 2012-05-22 2013-11-28 Novartis Ag Meningococcus serogroup x conjugate

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101208101A (zh) * 2005-06-27 2008-06-25 葛兰素史密丝克莱恩生物有限公司 免疫原性组合物
WO2008102173A1 (en) * 2007-02-21 2008-08-28 Health Protection Agency Compositions comprising polysaccharide conjugates and their use as vaccines

Also Published As

Publication number Publication date
MX354103B (es) 2018-02-13
KR20140123553A (ko) 2014-10-22
SG11201404447WA (en) 2014-08-28
EP2809349B1 (en) 2018-12-19
US9198977B2 (en) 2015-12-01
PT2809349T (pt) 2019-02-01
CA2863178A1 (en) 2013-08-08
HUE040914T4 (hu) 2019-05-28
EP2809349A1 (en) 2014-12-10
CA2863178C (en) 2021-04-06
SI2809349T1 (sl) 2019-03-29
JP2015509111A (ja) 2015-03-26
BR112014018815A2 (https=) 2017-06-20
BR112014018815A8 (pt) 2017-07-11
WO2013114268A1 (en) 2013-08-08
RU2634405C2 (ru) 2017-10-26
JP6042455B2 (ja) 2016-12-14
US20140377302A1 (en) 2014-12-25
DK2809349T3 (da) 2019-02-18
KR101897317B1 (ko) 2018-09-11
RU2014134288A (ru) 2016-03-20
EP2809349A4 (en) 2015-08-26
TR201900778T4 (tr) 2019-02-21
BR112014018815B1 (pt) 2022-07-12
ES2707294T3 (es) 2019-04-03
MX2014009250A (es) 2015-03-19
CN104302315A (zh) 2015-01-21

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