JP6042455B2 - 免疫原性組成物の調製方法 - Google Patents

免疫原性組成物の調製方法 Download PDF

Info

Publication number
JP6042455B2
JP6042455B2 JP2014555364A JP2014555364A JP6042455B2 JP 6042455 B2 JP6042455 B2 JP 6042455B2 JP 2014555364 A JP2014555364 A JP 2014555364A JP 2014555364 A JP2014555364 A JP 2014555364A JP 6042455 B2 JP6042455 B2 JP 6042455B2
Authority
JP
Japan
Prior art keywords
meningococcal
conjugate
serogroup
saccharide
immunogenic composition
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
JP2014555364A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015509111A5 (enExample
JP2015509111A (ja
Inventor
ヴィニヤック カプレ、サブハッシュ
ヴィニヤック カプレ、サブハッシュ
シャンカー ピサール、サンブハジ
シャンカー ピサール、サンブハジ
Original Assignee
セラム インスティチュート オブ インディア プライベイト リミテッド
セラム インスティチュート オブ インディア プライベイト リミテッド
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 セラム インスティチュート オブ インディア プライベイト リミテッド, セラム インスティチュート オブ インディア プライベイト リミテッド filed Critical セラム インスティチュート オブ インディア プライベイト リミテッド
Publication of JP2015509111A publication Critical patent/JP2015509111A/ja
Publication of JP2015509111A5 publication Critical patent/JP2015509111A5/ja
Application granted granted Critical
Publication of JP6042455B2 publication Critical patent/JP6042455B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—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 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
    • A61K47/64—Drug-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
    • A61K47/646—Drug-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
    • 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
    • A61K39/095—Neisseria
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • 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
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • 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
    • A61K2039/62—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
    • A61K2039/627—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier characterised by the linker
    • 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

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)
JP2014555364A 2012-01-30 2013-01-29 免疫原性組成物の調製方法 Active JP6042455B2 (ja)

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 (3)

Publication Number Publication Date
JP2015509111A JP2015509111A (ja) 2015-03-26
JP2015509111A5 JP2015509111A5 (enExample) 2016-02-25
JP6042455B2 true JP6042455B2 (ja) 2016-12-14

Family

ID=54259032

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014555364A Active JP6042455B2 (ja) 2012-01-30 2013-01-29 免疫原性組成物の調製方法

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
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

Family Cites Families (12)

* 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
GB0513069D0 (en) * 2005-06-27 2005-08-03 Glaxosmithkline Biolog Sa Immunogenic composition
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
GB0703369D0 (en) * 2007-02-21 2007-03-28 Health Prot Agency Compositions Comprising Capsular Polysaccharides and Their Use as Vaccines
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

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
CN104302315B (zh) 2018-02-06
JP2015509111A (ja) 2015-03-26
RU2634405C2 (ru) 2017-10-26
US20140377302A1 (en) 2014-12-25
SI2809349T1 (sl) 2019-03-29
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 (enExample) 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
JP6042455B2 (ja) 免疫原性組成物の調製方法
JP7851988B2 (ja) 非天然アミノ酸とのポリペプチド抗原接合体
Jones Vaccines based on the cell surface carbohydrates of pathogenic bacteria
JP2022105155A (ja) 多糖類－タンパク質コンジュゲートを含む多価肺炎球菌ワクチン組成物
IE58977B1 (en) Covalently-modified neutral bacterial polysaccharides, stable covalent conjugates of such plysaccharides and immunogenic proteins, and methods of preparing such polysaccharides and conjugates
CA2897348C (en) Cycloalkyne derivatized saccharides
CN113164581A (zh) 纯化的肺炎链球菌荚膜多糖
JP5744842B2 (ja) 髄膜炎菌と肺炎球菌との結合型ワクチン及びそれを使用する方法
US12053515B2 (en) Multivalent pneumococcal glycoconjugate vaccines containing emerging serotype 24F
JP2013504588A (ja) 免疫原性の高いタンパク質マトリックスワクチン
BE1024282B1 (fr) Compositions immunogènes
EA044044B1 (ru) Иммуногенные композиции, содержащие конъюгаты полипептид-антиген с неприродными аминокислотами

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160107

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20160108

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20160108

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20160204

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160301

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160601

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160621

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160916

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20161011

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20161109

R150 Certificate of patent or registration of utility model

Ref document number: 6042455

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250