BR112014018815B1 - Composição imunogênica compreendendo conjugado proteína-polissacarídeo x de n. meningitidis - Google Patents

Composição imunogênica compreendendo conjugado proteína-polissacarídeo x de n. meningitidis Download PDF

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Publication number
BR112014018815B1
BR112014018815B1 BR112014018815-7A BR112014018815A BR112014018815B1 BR 112014018815 B1 BR112014018815 B1 BR 112014018815B1 BR 112014018815 A BR112014018815 A BR 112014018815A BR 112014018815 B1 BR112014018815 B1 BR 112014018815B1
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BR
Brazil
Prior art keywords
saccharide
immunogenic composition
serogroup
meningitidis
conjugate
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BR112014018815-7A
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English (en)
Portuguese (pt)
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BR112014018815A2 (enExample
BR112014018815A8 (pt
Inventor
Subhash Vinayak Kapre
Sambhaji Shankar Pisal
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Serum Institute Of India Ltd.
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Application filed by Serum Institute Of India Ltd. filed Critical Serum Institute Of India Ltd.
Publication of BR112014018815A2 publication Critical patent/BR112014018815A2/pt
Publication of BR112014018815A8 publication Critical patent/BR112014018815A8/pt
Publication of BR112014018815B1 publication Critical patent/BR112014018815B1/pt

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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
    • 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
    • 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
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (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)
BR112014018815-7A 2012-01-30 2013-01-29 Composição imunogênica compreendendo conjugado proteína-polissacarídeo x de n. meningitidis BR112014018815B1 (pt)

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 (3)

Publication Number Publication Date
BR112014018815A2 BR112014018815A2 (enExample) 2017-06-20
BR112014018815A8 BR112014018815A8 (pt) 2017-07-11
BR112014018815B1 true BR112014018815B1 (pt) 2022-07-12

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BR112014018815-7A BR112014018815B1 (pt) 2012-01-30 2013-01-29 Composição imunogênica compreendendo conjugado proteína-polissacarídeo x de n. meningitidis

Country Status (17)

Country Link
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)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
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EP2201961B1 (en) 2005-06-27 2018-01-24 GlaxoSmithKline Biologicals S.A. Immunogenic composition
CA2892035C (en) * 2012-11-21 2019-11-05 Serum Institute Of India Ltd. Production of neisseria meningitidis x capsular polysaccharide
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
EP3302542A4 (en) 2015-06-08 2019-04-10 Serum Institute Of India Private Limited METHOD FOR IMPROVING ADSORPTION OF POLYSACCHARIDE PROTEIN CONJUGATES AND POLYVALENT VACCINE FORMULATION THEREOF
MY183392A (en) * 2015-07-04 2021-02-18 Bharat Biotech Int Ltd Polysaccharide vaccine formulations and processes for industrial production of bacterial polysaccharides
CN108883192A (zh) * 2016-03-15 2018-11-23 默沙东和惠康基金会合资的希勒曼实验室私人有限公司 新型多糖-蛋白质结合物及其获取工艺
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
PH12019500399B1 (en) * 2016-09-02 2024-05-15 Sanofi Pasteur Inc Neisseria meningitidis vaccine
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
UA125937C2 (uk) 2017-05-05 2022-07-13 Сірем Інстітьют Оф Індіа Прайвет Лімітед Спосіб видалення домішок з препаратів на основі бактеріальних капсульних полісахаридів
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
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
KR102871663B1 (ko) 2019-09-27 2025-10-16 화이자 인코포레이티드 네이세리아 메닌기티디스 조성물 및 그의 방법
JP7630603B2 (ja) 2020-08-10 2025-02-17 インベントプライズ・インコーポレイテッド 出現血清型24fを含む多価肺炎球菌複合糖質ワクチン
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

Family Cites Families (12)

* Cited by examiner, † Cited by third party
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FR2763244B1 (fr) * 1997-05-14 2003-08-01 Pasteur Merieux Serums Vacc Composition vaccinale multivalente a porteur mixte
SI1296715T2 (sl) * 2000-06-29 2016-03-31 Smithkline Beecham Biologicals S.A. Multivalentni sestavek cepiva
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
CA2540896C (en) * 2003-10-02 2015-06-02 Chiron Srl Liquid vaccines for multiple meningococcal serogroups
EP2201961B1 (en) * 2005-06-27 2018-01-24 GlaxoSmithKline Biologicals S.A. Immunogenic composition
GB0513069D0 (en) * 2005-06-27 2005-08-03 Glaxosmithkline Biolog Sa Immunogenic composition
WO2007026249A2 (en) * 2005-09-01 2007-03-08 Novartis Vaccines And Diagnostics Gmbh & Co Kg Multiple vaccination including serogroup c meningococcus
CA2808919C (en) * 2005-12-22 2016-04-19 Glaxosmithkline Biologicals S.A. Streptococcus pneumoniae capsular saccharide vaccine
GB0703369D0 (en) * 2007-02-21 2007-03-28 Health Prot Agency Compositions Comprising Capsular Polysaccharides and Their Use as Vaccines
DK2513056T3 (da) * 2009-12-17 2022-05-23 Serum Inst Of India Pvt Ltd Kemiske reagenser til aktivering af polysaccharider i fremstillingen af konjugatvacciner
US10124051B2 (en) * 2012-05-22 2018-11-13 Glaxosmithkline Biologicals Sa Meningococcus serogroup X conjugate

Also Published As

Publication number Publication date
EP2809349A4 (en) 2015-08-26
MX2014009250A (es) 2015-03-19
PT2809349T (pt) 2019-02-01
JP6042455B2 (ja) 2016-12-14
EP2809349B1 (en) 2018-12-19
RU2634405C2 (ru) 2017-10-26
CA2863178A1 (en) 2013-08-08
RU2014134288A (ru) 2016-03-20
WO2013114268A1 (en) 2013-08-08
US20140377302A1 (en) 2014-12-25
SG11201404447WA (en) 2014-08-28
BR112014018815A2 (enExample) 2017-06-20
EP2809349A1 (en) 2014-12-10
DK2809349T3 (da) 2019-02-18
KR101897317B1 (ko) 2018-09-11
CA2863178C (en) 2021-04-06
SI2809349T1 (sl) 2019-03-29
CN104302315A (zh) 2015-01-21
KR20140123553A (ko) 2014-10-22
MX354103B (es) 2018-02-13
HUE040914T4 (hu) 2019-05-28
JP2015509111A (ja) 2015-03-26
TR201900778T4 (tr) 2019-02-21
BR112014018815A8 (pt) 2017-07-11
CN104302315B (zh) 2018-02-06
ES2707294T3 (es) 2019-04-03
US9198977B2 (en) 2015-12-01

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/01/2013, OBSERVADAS AS CONDICOES LEGAIS