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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Publication of CN104302315A publication Critical patent/CN104302315A/zh
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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)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (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
IN281/MUM/2012 2012-01-30
IN281MU2012 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 (enExample)
EP (1) EP2809349B1 (enExample)
JP (1) JP6042455B2 (enExample)
KR (1) KR101897317B1 (enExample)
CN (1) CN104302315B (enExample)
BR (1) BR112014018815B1 (enExample)
CA (1) CA2863178C (enExample)
DK (1) DK2809349T3 (enExample)
ES (1) ES2707294T3 (enExample)
HU (1) HUE040914T4 (enExample)
MX (1) MX354103B (enExample)
PT (1) PT2809349T (enExample)
RU (1) RU2634405C2 (enExample)
SG (1) SG11201404447WA (enExample)
SI (1) SI2809349T1 (enExample)
TR (1) TR201900778T4 (enExample)
WO (1) WO2013114268A1 (enExample)

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PL2878307T3 (pl) 2005-06-27 2020-01-31 Glaxosmithkline Biologicals S.A. Kompozycja immunogenna
CN104936615B (zh) * 2012-11-21 2017-03-29 印度血清研究所私人有限公司 高产量的细菌多糖的制备
WO2015029056A1 (en) 2013-08-24 2015-03-05 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
MX2017015985A (es) * 2015-06-08 2018-08-15 Serum Inst Of India Private Ltd Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y formulacion de vacuna multivalente obtenida con los mismos.
AU2016290233A1 (en) * 2015-07-04 2018-01-25 Bharat Biotech International Limited Polysaccharide vaccine formulations and processes for industrial production of bacterial polysaccharides
BR112018068523A2 (pt) * 2016-03-15 2019-01-22 Msd Wellcome Trust Hilleman Laboratories Pvt Ltd novos conjugados de polissacarídeo-proteína e processo para obter os mesmos
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
KR20190044663A (ko) 2016-09-02 2019-04-30 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
AU2018262438B2 (en) * 2017-05-05 2022-07-14 Serum Institute Of India Private Limited Method for removal of impurities from bacterial capsular polysaccharide based preparations
BR112019027182A2 (pt) * 2017-06-27 2020-06-30 Msd Wellcome Trust Hilleman Laboratories Pvt. Ltd. nova composição de vacina conjugada de proteína - polissacarídeo multivalente e formulação da mesma
US20200353064A1 (en) * 2018-01-29 2020-11-12 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
CA3155669A1 (en) 2019-09-27 2021-04-01 Pfizer Inc. Neisseria meningitidis compositions and methods thereof
EP4192499A4 (en) 2020-08-10 2024-09-25 Inventprise, Inc. 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)

* Cited by examiner, † Cited by third party
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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
CZ20024224A3 (cs) * 2000-06-29 2003-05-14 Glaxosmithkline Biologicals S. A. Farmaceutický prostředek
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
ATE506963T1 (de) * 2003-10-02 2011-05-15 Novartis Vaccines & Diagnostic Kombinationsimpfstoffe gegen meningitis
PL2878307T3 (pl) * 2005-06-27 2020-01-31 Glaxosmithkline Biologicals S.A. Kompozycja immunogenna
CN101287488B (zh) * 2005-09-01 2013-01-30 诺华疫苗和诊断有限两合公司 含血清群c脑膜炎球菌的多价疫苗
PL3017827T3 (pl) * 2005-12-22 2019-04-30 Glaxosmithkline Biologicals Sa Szczepionka z koniugatem polisacharydu pneumokokowego
KR101635795B1 (ko) * 2009-12-17 2016-07-04 피나 바이오솔루션스, 엘엘씨 다당류/단백질 접합체 백신의 제조에 있어서 시안화제인 1-시아노벤조트리아졸 (1-cbt)을 통한 다당류의 활성화
AU2013265336A1 (en) * 2012-05-22 2014-12-04 Novartis Ag Meningococcus serogroup X conjugate

Patent Citations (2)

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

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