AR084158A1 - Formulaciones que mitigan la agregacion inducida por agitacion de composiciones inmunogenicas - Google Patents

Formulaciones que mitigan la agregacion inducida por agitacion de composiciones inmunogenicas

Info

Publication number
AR084158A1
AR084158A1 ARP110104542A ARP110104542A AR084158A1 AR 084158 A1 AR084158 A1 AR 084158A1 AR P110104542 A ARP110104542 A AR P110104542A AR P110104542 A ARP110104542 A AR P110104542A AR 084158 A1 AR084158 A1 AR 084158A1
Authority
AR
Argentina
Prior art keywords
formulations
poloxamer
mitigate
immunogenic compositions
agmation
Prior art date
Application number
ARP110104542A
Other languages
English (en)
Original Assignee
Merck Sharp & Dohme
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 Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of AR084158A1 publication Critical patent/AR084158A1/es

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K39/385—Haptens or antigens, bound to carriers
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • 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
    • 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
    • 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
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Toxicology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Agronomy & Crop Science (AREA)
  • Pest Control & Pesticides (AREA)
  • Plant Pathology (AREA)
  • Dentistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Environmental Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

Formulaciones que mitigan la agregación inducida por agitación de composiciones inmunogénicas particularmente aquellas que tienen conjugados de polisacárido-proteína. Específicamente, las formulaciones comprenden un poloxámero dentro del intervalo de peso molecular de 1.100 a 17.400 que proporciona ventajas significativas con respecto a tensioactivos usados previamente que incluyen polisorbato 80. En una realización, proporciona una composición inmunogénica multivalente que tiene 15 conjugados de polisacárido-proteína diferentes y un poloxámero. Cada conjugado consiste en un polisacárido capsular preparado a partir de un serotipo diferente de Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F o 33F) conjugado a una proteína transportadora, preferentemente CRM197.Reivindicación 2: El poloxámero de la reivindicación 1 que tiene un peso molecular en el intervalo de 7.500 a 15.000.
ARP110104542A 2010-12-10 2011-12-05 Formulaciones que mitigan la agregacion inducida por agitacion de composiciones inmunogenicas AR084158A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US42196010P 2010-12-10 2010-12-10

Publications (1)

Publication Number Publication Date
AR084158A1 true AR084158A1 (es) 2013-04-24

Family

ID=46207464

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP110104542A AR084158A1 (es) 2010-12-10 2011-12-05 Formulaciones que mitigan la agregacion inducida por agitacion de composiciones inmunogenicas

Country Status (13)

Country Link
US (1) US20130273098A1 (es)
EP (1) EP2648506A1 (es)
JP (1) JP2014502595A (es)
KR (1) KR20140005892A (es)
CN (1) CN103391714A (es)
AR (1) AR084158A1 (es)
AU (1) AU2011338723A1 (es)
BR (1) BR112013012626A2 (es)
CA (1) CA2819366A1 (es)
MX (1) MX2013006539A (es)
RU (1) RU2013131795A (es)
TW (1) TW201304803A (es)
WO (1) WO2012078482A1 (es)

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011014487A1 (en) 2009-07-30 2011-02-03 Merck Sharp & Dohme Corp. Hepatitis c virus ns3 protease inhibitors
EP2575870B1 (en) * 2010-06-04 2016-12-07 Wyeth LLC Vaccine formulations
KR102057217B1 (ko) 2012-06-20 2020-01-22 에스케이바이오사이언스 주식회사 다가 폐렴구균 다당류-단백질 접합체 조성물
MX363511B (es) * 2012-08-16 2019-03-26 Pfizer Proceso de glucoconjugación y composiciones.
CN103623401A (zh) * 2012-08-23 2014-03-12 北京科兴中维生物技术有限公司 多价肺炎球菌荚膜多糖-蛋白质共轭组合物及其制备方法
KR20140075196A (ko) 2012-12-11 2014-06-19 에스케이케미칼주식회사 다가 폐렴구균 다당류-단백질 접합체 조성물
MX365331B (es) 2013-01-17 2019-05-29 Arsanis Biosciences Gmbh Anticuerpo específico contra e. coli mdr.
CN104069488A (zh) * 2013-03-29 2014-10-01 北京科兴中维生物技术有限公司 多价肺炎球菌荚膜多糖-蛋白质共轭组合物及其制备方法
IL296681B2 (en) * 2014-01-21 2024-09-01 Pfizer Immunogenic preparations including conjugated capsular saccharide antigens and their uses
HUE055553T2 (hu) * 2014-01-21 2021-12-28 Pfizer Streptococcus pneumoniae kapszulás poliszacharidok és azok konjugátumai
US11160855B2 (en) * 2014-01-21 2021-11-02 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof
EP3957321A3 (en) * 2014-01-21 2022-07-13 Pfizer Inc. Streptococcus pneumoniae capsular polysaccharides and conjugates thereof
AU2015220723C1 (en) 2014-02-24 2018-04-05 Glaxosmithkline Biologicals Sa Novel polysaccharide and uses thereof
TN2017000126A1 (en) * 2014-10-09 2018-10-19 Msd Wellcome Trust Hilleman Laboratories Pvt Ltd An improved process of conjugation and novel synthetic oligosaccharide- protein conjugates obtained thereof
CA2988366C (en) * 2015-06-08 2021-12-07 Serum Institute Of India Private Ltd. Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof.
PE20240927A1 (es) 2015-07-21 2024-04-30 Pfizer Composiciones inmunogenas que comprenden antigenos de sacarido capsular conjugados, kits que las comprenden y sus usos
TWI715617B (zh) 2015-08-24 2021-01-11 比利時商葛蘭素史密斯克藍生物品公司 對抗腸道外病原性大腸桿菌之免疫保護之方法及組合物
AR109621A1 (es) 2016-10-24 2018-12-26 Janssen Pharmaceuticals Inc Formulaciones de vacunas contra glucoconjugados de expec
US11951165B2 (en) 2016-12-30 2024-04-09 Vaxcyte, Inc. Conjugated vaccine carrier proteins
KR20190103256A (ko) 2016-12-30 2019-09-04 수트로박스, 인코포레이티드 비자연 아미노산을 갖는 폴리펩타이드-항원 접합체
US11197921B2 (en) 2017-01-31 2021-12-14 Merck Sharp & Dohme Corp. Methods for making polysaccharide-protein conjugates
KR102650073B1 (ko) 2017-01-31 2024-03-20 머크 샤프 앤드 돔 엘엘씨 스트렙토코커스 뉴모니아 혈청형 19f 유래의 협막 다당류 단백질 접합체의 제조 방법
WO2018156468A1 (en) * 2017-02-24 2018-08-30 Merck Sharp & Dohme Corp. Pneumococcal conjugate vaccine formulations
US11219680B2 (en) 2017-02-24 2022-01-11 Merck Sharp & Dohme Corp. Polysaccharide-protein conjugates utilizing diphtheria toxin fragment B as a carrier
EP3589314A4 (en) 2017-02-24 2021-04-21 Merck Sharp & Dohme Corp. INCREASED IMMUNOGENICITY OF STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE PROTEIN CONJUGATES
KR20200040812A (ko) * 2017-08-16 2020-04-20 머크 샤프 앤드 돔 코포레이션 폐렴구균 접합체 백신 제제
CA3074703A1 (en) 2017-09-07 2019-03-14 Merck Sharp & Dohme Corp. Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates
AU2018328036B2 (en) * 2017-09-07 2024-03-07 Merck Sharp & Dohme Llc Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates
WO2019050816A1 (en) 2017-09-07 2019-03-14 Merck Sharp & Dohme Corp. ANTI-PNEUMOCOCCAL POLYSACCHARIDES AND THEIR USE IN IMMUNOGENIC CONJUGATES POLYSACCHARIDE-PROTEIN CARRIER
US20200325020A1 (en) * 2017-10-25 2020-10-15 Merck Sharp & Dohme Corp. Adjuvanted vaccines
CN117982633A (zh) 2017-12-06 2024-05-07 默沙东有限责任公司 包含肺炎链球菌多糖蛋白缀合物的组合物及其使用方法
BR112020020802A2 (pt) * 2018-04-13 2021-01-12 Genentech, Inc. Composições farmacêuticas, composições farmacêuticas produzidas por liofilização, composições líquidas, composição farmacêutica compreendendo um imunoconjugado anti-cd79b, frasco de vidro, composição líquida compreendendo um imunoconjugado anti-cd79b, composições farmacêuticas liofilizadas, composição liofilizada, composições farmacêuticas líquidas, método para tratar um distúrbio proliferativo
EP3787673A4 (en) 2018-04-30 2022-04-27 Merck Sharp & Dohme Corp. METHODS FOR PRODUCING CAPSULAR CARRIER PROTEIN-POLYSACCHARIDE CONJUGATES OF STREPTOCOCCUS PNEUMONIAE
WO2019212844A1 (en) 2018-04-30 2019-11-07 Merck Sharp & Dohme Corp. Methods for providing a homogenous solution of lyophilized mutant diptheria toxin in dimethylsulfoxide
SG11202106541WA (en) 2018-12-19 2021-07-29 Merck Sharp & Dohme Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
US11446370B2 (en) 2019-03-18 2022-09-20 Janssen Pharmaceuticals, Inc. Bioconjugates of E. coli o-antigen polysaccharides, methods of production thereof, and methods of use thereof
JP2022525773A (ja) 2019-03-18 2022-05-19 ヤンセン ファーマシューティカルズ，インコーポレーテッド 大腸菌ｏ抗原多糖のバイオコンジュゲートを製造する方法、その組成物およびその使用方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE360640T1 (de) * 2000-08-08 2007-05-15 St Jude Childrens Res Hospital Gruppe-b streptococcus polypeptide, nukleinsäure, therapeutische zusammensetzungen und impfstoffe davon
ES2564241T3 (es) * 2005-12-02 2016-03-21 Glaxosmithkline Biologicals Sa Nanopartículas para su uso en composiciones inmunogénicas
AU2006330858A1 (en) * 2005-12-21 2007-07-05 Wyeth Protein formulations with reduced viscosity and uses thereof
TW200806315A (en) * 2006-04-26 2008-02-01 Wyeth Corp Novel formulations which stabilize and inhibit precipitation of immunogenic compositions
AU2008259423A1 (en) * 2007-06-04 2008-12-11 Novartis Ag Formulation of meningitis vaccines
JP5555623B2 (ja) * 2007-06-20 2014-07-23 バクスター・インターナショナル・インコーポレイテッド コンジュゲートワクチン用修飾多糖
US8962026B2 (en) * 2008-09-26 2015-02-24 The Regents Of The University Of Michigan Nanoemulsion therapeutic compositions and methods of using the same

Also Published As

Publication number Publication date
CA2819366A1 (en) 2012-06-14
MX2013006539A (es) 2013-07-22
US20130273098A1 (en) 2013-10-17
TW201304803A (zh) 2013-02-01
BR112013012626A2 (pt) 2016-07-19
EP2648506A1 (en) 2013-10-16
WO2012078482A1 (en) 2012-06-14
CN103391714A (zh) 2013-11-13
AU2011338723A1 (en) 2013-05-30
JP2014502595A (ja) 2014-02-03
KR20140005892A (ko) 2014-01-15
RU2013131795A (ru) 2015-01-20

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