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

Info

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
Authority
CN
China
Prior art keywords
conjugate
serogroup
meningitidis
neisseria meningitidis
polysaccharide
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CN201380017781.9A
Other languages
English (en)
Chinese (zh)
Other versions
CN104302315A (zh
Inventor
苏布哈什·维纳亚克·卡普雷
萨姆哈吉·尚卡尔·皮萨尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Serum Institute of India Pvt Ltd
Original Assignee
Serum Institute of India Pvt Ltd
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 Serum Institute of India Pvt Ltd filed Critical Serum Institute of India Pvt Ltd
Publication of CN104302315A publication Critical patent/CN104302315A/zh
Application granted granted Critical
Publication of CN104302315B publication Critical patent/CN104302315B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (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

Family

ID=54259032

Family Applications (1)

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

Country Status (17)

Country Link
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=)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20110072A1 (es) * 2005-06-27 2011-02-04 Glaxosmithkline Biolog Sa Composicion inmunogenica
WO2014080423A2 (en) * 2012-11-21 2014-05-30 Serum Institute Of India Ltd. Production of high yields of bacterial polysaccharides
KR102447303B1 (ko) * 2013-08-24 2022-09-23 브하라트 바이오테크 인터내셔날 리미티드 박테리아성 백신 및 그의 제조방법
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
EA201792470A1 (ru) * 2015-06-08 2018-10-31 Серум Инститьют Оф Индия Прайват Лтд. Способы улучшения адсорбции полисахарид-белковых конъюгатов и полученная из них композиция поливалентной вакцины
WO2017006349A1 (en) * 2015-07-04 2017-01-12 Bharat Biotech International Limited Polysaccharide vaccine formulations and processes for industrial production of bacterial polysaccharides
JP2019508468A (ja) * 2016-03-15 2019-03-28 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. 新規の多糖体−タンパク質コンジュゲート及びそれを得る方法
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
BR112019003992A2 (pt) * 2016-09-02 2019-05-28 Sanofi Pasteur Inc vacina contra neisseria meningitidis
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
US11739356B2 (en) 2017-05-05 2023-08-29 Serum Institute Of India Private Limited Method for removal of impurities from bacterial capsular polysaccharide based preparations
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
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
WO2021059181A1 (en) 2019-09-27 2021-04-01 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)

* 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

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
NZ546430A (en) * 2003-10-02 2009-04-30 Novartis Vaccines & Diagnostic Liquid vaccines for multiple meningococcal serogroups
PE20110072A1 (es) * 2005-06-27 2011-02-04 Glaxosmithkline Biolog Sa Composicion inmunogenica
JP5135220B2 (ja) * 2005-09-01 2013-02-06 ノバルティス ヴァクシンズ アンド ダイアグノスティクス ゲーエムベーハー アンド カンパニー カーゲー 血清群c髄膜炎菌を含む複数ワクチン接種
KR101515078B1 (ko) * 2005-12-22 2015-04-24 글락소스미스클라인 바이오로지칼즈 에스.에이. 백신
CA2836153C (en) * 2009-12-17 2016-06-21 Fina Biosolutions, Llc Chemical reagents for the activation of polysaccharides in the preparation of conjugate vaccines
RU2014151567A (ru) * 2012-05-22 2016-07-10 Новартис Аг Конъюгат менингококка серогруппы х

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

Similar Documents

Publication Publication Date Title
CN104302315B (zh) 免疫原性组合物及其制备方法
JP7851988B2 (ja) 非天然アミノ酸とのポリペプチド抗原接合体
US8753649B2 (en) Polysaccharide-protein conjugate vaccines
CN103623405B (zh) 多糖-蛋白轭合物疫苗
IE58977B1 (en) Covalently-modified neutral bacterial polysaccharides, stable covalent conjugates of such plysaccharides and immunogenic proteins, and methods of preparing such polysaccharides and conjugates
US12053515B2 (en) Multivalent pneumococcal glycoconjugate vaccines containing emerging serotype 24F

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information

Address after: India Maharashtra, Pune City

Applicant after: Serum Institute of India Private Limited Company

Address before: India Maharashtra, Pune City

Applicant before: SERUM INST INDIA LTD.

COR Change of bibliographic data
GR01 Patent grant
GR01 Patent grant