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PE20180460A1 - Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos - Google Patents

Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos

Info

Publication number
PE20180460A1
PE20180460A1 PE2017002539A PE2017002539A PE20180460A1 PE 20180460 A1 PE20180460 A1 PE 20180460A1 PE 2017002539 A PE2017002539 A PE 2017002539A PE 2017002539 A PE2017002539 A PE 2017002539A PE 20180460 A1 PE20180460 A1 PE 20180460A1
Authority
PE
Peru
Prior art keywords
adsorption
polysaccharide
methods
improve
same
Prior art date
Application number
PE2017002539A
Other languages
English (en)
Inventor
Rajeev Mhalasakant Dhere
Hitesh Kumar Malviya
Swapan Kumar Jana
Sambhaji Shankar Pisal
Asha Dinesh MALLYA
Sunil Mahor
Manish Maheshkumar Gautam
Chetan Vilas Joshi
Venkata Vamsi Krishna Malepati
Prashant Shivaji Jadhav
Original Assignee
Serum Inst Of India Private 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 Inst Of India Private Ltd filed Critical Serum Inst Of India Private Ltd
Publication of PE20180460A1 publication Critical patent/PE20180460A1/es

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    • 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
    • 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
    • A61K39/085—Staphylococcus
    • 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
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • 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
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • 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
    • A61K39/116—Polyvalent bacterial antigens
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/6415—Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55516—Proteins; Peptides
    • 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
    • A61K2039/70—Multivalent vaccine

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Virology (AREA)
  • Toxicology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Referido a metodos para la preparacion de formulaciones estables de vacunas antineumococcicas conjugadas de polisacarido-proteina multivalentes, las cuales presentan un porcentaje optimo de adsorcion para cada conjugado, en donde se puede prevenir la agregacion mediante el uso de al menos uno de i) una adsorcion individual o separada de conjugados que de lo contrario presentan un porcentaje de adsorcion menor con una adsorcion combinada, ii) un sistema de solucion amortiguadora de histidina-acido succinico junto con un cambio en el pH de pH neutro a pH acido, iii) una relacion de polisacarido a proteina de entre 0,5 a aproximadamente 1,4 y iv) un impulsor de turbina tipo Rushton de seis hojas en los recipientes de formulacion
PE2017002539A 2015-06-08 2016-06-03 Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos PE20180460A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2185MU2015 2015-06-08

Publications (1)

Publication Number Publication Date
PE20180460A1 true PE20180460A1 (es) 2018-03-06

Family

ID=57503115

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2017002539A PE20180460A1 (es) 2015-06-08 2016-06-03 Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos

Country Status (18)

Country Link
US (1) US10729780B2 (es)
EP (1) EP3302542A4 (es)
JP (2) JP7258463B2 (es)
KR (2) KR20240007690A (es)
CN (1) CN107847571A (es)
AU (2) AU2016276269B2 (es)
BR (1) BR112017026343A2 (es)
CA (1) CA2988366C (es)
CO (1) CO2017012628A2 (es)
EA (1) EA201792470A1 (es)
IL (1) IL256118B (es)
MX (1) MX2017015985A (es)
MY (1) MY187461A (es)
PE (1) PE20180460A1 (es)
PH (1) PH12017502244A1 (es)
SA (1) SA517390495B1 (es)
WO (1) WO2016199003A1 (es)
ZA (1) ZA201708325B (es)

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TWI807252B (zh) 2015-05-04 2023-07-01 美商輝瑞股份有限公司 Ｂ型鏈球菌多醣-蛋白質軛合物、製造軛合物之方法、含軛合物之免疫原性組成物、及其用途
MY187461A (en) * 2015-06-08 2021-09-23 Serum Inst Of India Private Ltd Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof
CN106822884B (zh) * 2016-12-28 2021-04-30 北京民海生物科技有限公司 一种多价肺炎球菌荚膜多糖结合疫苗的制备方法
MX2019007910A (es) 2016-12-30 2019-12-05 Sutrovax Inc Conjugados de polipeptido-antigeno con aminoacidos no naturales.
US11951165B2 (en) 2016-12-30 2024-04-09 Vaxcyte, Inc. Conjugated vaccine carrier proteins
CA3049985A1 (en) * 2017-02-24 2018-08-30 Merck Sharp & Dohme Corp. Pneumococcal polysaccharide-protein vaccine formulations comprising improved surfactant systems
US10729763B2 (en) 2017-06-10 2020-08-04 Inventprise, Llc Mixtures of polysaccharide-protein pegylated compounds
WO2019050814A1 (en) * 2017-09-07 2019-03-14 Merck Sharp & Dohme Corp. ANTI-PNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN IMMUNOGENIC CONJUGATES POLYSACCHARIDE-PROTEIN CARRIER
CA3084436A1 (en) 2017-12-06 2019-07-18 Merck Sharp & Dohme Corp. Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
CN108524926B (zh) * 2018-06-29 2021-06-29 康希诺生物股份公司 一种多价肺炎球菌结合疫苗的制剂组合及其应用
JOP20210148A1 (ar) 2018-12-19 2023-01-30 Merck Sharp & Dohme تركيبات تشتمل على متقارنات بولي سكاريد-بروتين للمكورات العقدية الرئوية وطرق استخدامها
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CN113607939B (zh) * 2021-08-05 2024-10-22 艾美探索者生命科学研发有限公司 肺炎球菌多糖结合疫苗各型结合原液吸附率测定方法
EP4450082A1 (en) * 2023-04-17 2024-10-23 Serum Institute Of India Private Limited Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

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MY187461A (en) * 2015-06-08 2021-09-23 Serum Inst Of India Private Ltd Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

Also Published As

Publication number Publication date
BR112017026343A2 (pt) 2019-11-19
KR20240007690A (ko) 2024-01-16
AU2024202450A1 (en) 2024-10-31
KR20180030498A (ko) 2018-03-23
SA517390495B1 (ar) 2023-03-23
CA2988366A1 (en) 2016-12-15
EP3302542A1 (en) 2018-04-11
MY187461A (en) 2021-09-23
JP7258463B2 (ja) 2023-04-17
CO2017012628A2 (es) 2018-03-28
KR102690378B1 (ko) 2024-08-01
IL256118A (en) 2018-02-28
WO2016199003A1 (en) 2016-12-15
US20180161445A1 (en) 2018-06-14
PH12017502244A1 (en) 2018-06-11
ZA201708325B (en) 2019-05-29
NZ738090A (en) 2023-09-29
EP3302542A4 (en) 2019-04-10
IL256118B (en) 2021-12-01
JP2018516962A (ja) 2018-06-28
US10729780B2 (en) 2020-08-04
MX2017015985A (es) 2018-08-15
EA201792470A1 (ru) 2018-10-31
CA2988366C (en) 2021-12-07
AU2016276269A1 (en) 2018-01-18
AU2016276269B2 (en) 2021-01-28
CN107847571A (zh) 2018-03-27
JP2021185152A (ja) 2021-12-09

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