AU2016276269B2 - Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof - Google Patents

Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof Download PDF

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Publication number
AU2016276269B2
AU2016276269B2 AU2016276269A AU2016276269A AU2016276269B2 AU 2016276269 B2 AU2016276269 B2 AU 2016276269B2 AU 2016276269 A AU2016276269 A AU 2016276269A AU 2016276269 A AU2016276269 A AU 2016276269A AU 2016276269 B2 AU2016276269 B2 AU 2016276269B2
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polysaccharide
serotype
protein
composition
conjugated
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AU2016276269A1 (en
Inventor
Rajeev Mhalasakant DHERE
Manish Maheshkumar GAUTAM
Prashant Shivaji JADHAV
Swapan Kumar Jana
Chetan Vilas JOSHI
Sunil MAHOR
Venkata Vamsi Krishna MALEPATI
Asha Dinesh MALLYA
Hitesh Kumar Malviya
Sambhaji Shankar PISAL
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Serum Institute of India Pvt Ltd
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Serum Institute of India Pvt Ltd
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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

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  • 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)
  • Inorganic Chemistry (AREA)
  • Toxicology (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)
AU2016276269A 2015-06-08 2016-06-03 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof Active AU2016276269B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024202450A AU2024202450A1 (en) 2015-06-08 2024-04-15 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2185/MUM/2015 2015-06-08
IN2185MU2015 2015-06-08
PCT/IB2016/053265 WO2016199003A1 (en) 2015-06-08 2016-06-03 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

Related Child Applications (1)

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AU2024202450A Addition AU2024202450A1 (en) 2015-06-08 2024-04-15 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

Publications (2)

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AU2016276269A1 AU2016276269A1 (en) 2018-01-18
AU2016276269B2 true AU2016276269B2 (en) 2021-01-28

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AU2016276269A Active AU2016276269B2 (en) 2015-06-08 2016-06-03 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof
AU2024202450A Pending AU2024202450A1 (en) 2015-06-08 2024-04-15 Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

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Country Status (17)

Country Link
US (1) US10729780B2 (https=)
EP (1) EP3302542A4 (https=)
JP (2) JP7258463B2 (https=)
KR (2) KR102690378B1 (https=)
CN (1) CN107847571A (https=)
AU (2) AU2016276269B2 (https=)
CA (1) CA2988366C (https=)
CO (1) CO2017012628A2 (https=)
EA (1) EA201792470A1 (https=)
IL (1) IL256118B (https=)
MX (1) MX2017015985A (https=)
MY (1) MY187461A (https=)
PE (1) PE20180460A1 (https=)
PH (1) PH12017502244A1 (https=)
SA (1) SA517390495B1 (https=)
WO (1) WO2016199003A1 (https=)
ZA (1) ZA201708325B (https=)

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PE20220774A1 (es) 2015-05-04 2022-05-16 Pfizer Conjugados proteina-polisacarido de estreptococo grupo b, metodos para producir conjugados, composiciones inmunogenas que comprenden conjugados y sus usos
PE20180460A1 (es) * 2015-06-08 2018-03-06 Serum Inst Of India Private Ltd Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos
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
ES3024474T3 (en) 2016-12-30 2025-06-04 Vaxcyte Inc Polypeptide-antigen conjugates with non-natural amino acids
US11951165B2 (en) 2016-12-30 2024-04-09 Vaxcyte, Inc. Conjugated vaccine carrier proteins
PT3585803T (pt) * 2017-02-24 2025-12-22 Merck Sharp & Dohme Formulações de vacina pneumocócica conjugada
US10729763B2 (en) 2017-06-10 2020-08-04 Inventprise, Llc Mixtures of polysaccharide-protein pegylated compounds
EP3678655A4 (en) * 2017-09-07 2021-05-05 Merck Sharp & Dohme Corp. PNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN IMMUNOGENIC POLYSACCHARIDE CARRIER PROTEIN CONJUGATES
TWI725359B (zh) 2017-12-06 2021-04-21 美商默沙東藥廠 包含肺炎鏈球菌多醣-蛋白結合物之組合物及其使用方法
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
GB201818517D0 (en) * 2018-11-13 2018-12-26 Univ Liverpool John Moores Nanoparticles and uses thereof
GEAP202415690A (en) 2018-12-19 2024-01-10 Merck Sharp & Dohme Llc Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
MX2021014710A (es) * 2019-06-05 2022-01-18 Merck Sharp & Dohme Llc Un conjugado inmunogenico de polisacarido de neumococo del serotipo 35b- proteina y proceso de conjugacion para preparar el mismo.
US12473379B2 (en) 2019-09-06 2025-11-18 Serum Institute Of India Private Limited Method for obtaining purified bacterial polysaccharides
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
CN115006522B (zh) * 2022-06-16 2025-08-22 北京智飞绿竹生物制药有限公司 一种双价痢疾结合物组合疫苗的制备方法
CA3232076A1 (en) * 2023-04-17 2025-04-14 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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US20100209450A1 (en) * 2007-06-26 2010-08-19 Ralph Leon Biemans Vaccine comprising streptococcus pneumoniae capsular polysaccharide conjugates
US20130273098A1 (en) * 2010-12-10 2013-10-17 Jeffrey T. Blue Novel formulations which mitigate agitation-induced aggregation of immunogenic compositions

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PE20180460A1 (es) * 2015-06-08 2018-03-06 Serum Inst Of India Private Ltd Metodos para mejorar la adsorcion de conjugados de polisacarido-proteina y una formulacion de vacuna multivalente obtenida con los mismos

Patent Citations (2)

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US20100209450A1 (en) * 2007-06-26 2010-08-19 Ralph Leon Biemans Vaccine comprising streptococcus pneumoniae capsular polysaccharide conjugates
US20130273098A1 (en) * 2010-12-10 2013-10-17 Jeffrey T. Blue Novel formulations which mitigate agitation-induced aggregation of immunogenic compositions

Also Published As

Publication number Publication date
EP3302542A1 (en) 2018-04-11
EA201792470A1 (ru) 2018-10-31
SA517390495B1 (ar) 2023-03-23
AU2024202450A1 (en) 2024-10-31
KR20180030498A (ko) 2018-03-23
IL256118A (en) 2018-02-28
MY187461A (en) 2021-09-23
JP2021185152A (ja) 2021-12-09
EP3302542A4 (en) 2019-04-10
KR102876828B1 (ko) 2025-10-27
KR20240007690A (ko) 2024-01-16
PE20180460A1 (es) 2018-03-06
MX2017015985A (es) 2018-08-15
CA2988366A1 (en) 2016-12-15
IL256118B (en) 2021-12-01
CN107847571A (zh) 2018-03-27
ZA201708325B (en) 2019-05-29
NZ738090A (en) 2023-09-29
JP2018516962A (ja) 2018-06-28
WO2016199003A1 (en) 2016-12-15
CA2988366C (en) 2021-12-07
JP7258463B2 (ja) 2023-04-17
US10729780B2 (en) 2020-08-04
KR102690378B1 (ko) 2024-08-01
PH12017502244A1 (en) 2018-06-11
CO2017012628A2 (es) 2018-03-28
US20180161445A1 (en) 2018-06-14
AU2016276269A1 (en) 2018-01-18
BR112017026343A2 (pt) 2019-11-19

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