CN109952372A - 获得有效用于疫苗接种或基因治疗的基于病毒载体的组合物的新方法 - Google Patents

获得有效用于疫苗接种或基因治疗的基于病毒载体的组合物的新方法 Download PDF

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CN109952372A
CN109952372A CN201780070621.9A CN201780070621A CN109952372A CN 109952372 A CN109952372 A CN 109952372A CN 201780070621 A CN201780070621 A CN 201780070621A CN 109952372 A CN109952372 A CN 109952372A
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composition
particles
viral vectors
viral
adenoviral
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K·克姆特
M·肖尔茨
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Leukocare AG
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Leukocare AG
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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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10023—Virus like particles [VLP]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10041—Use of virus, viral particle or viral elements as a vector
    • C12N2710/10043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/10011—Adenoviridae
    • C12N2710/10051—Methods of production or purification of viral material

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201780070621.9A 2016-09-16 2017-09-15 获得有效用于疫苗接种或基因治疗的基于病毒载体的组合物的新方法 Pending CN109952372A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16189276 2016-09-16
EP16189276.5 2016-09-16
PCT/EP2017/073370 WO2018050872A1 (en) 2016-09-16 2017-09-15 A novel method for obtaining efficient viral vector-based compositions for vaccination or gene therapy

Publications (1)

Publication Number Publication Date
CN109952372A true CN109952372A (zh) 2019-06-28

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CN201780070621.9A Pending CN109952372A (zh) 2016-09-16 2017-09-15 获得有效用于疫苗接种或基因治疗的基于病毒载体的组合物的新方法

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US (2) US11166915B2 (https=)
EP (1) EP3512939A1 (https=)
JP (1) JP7051132B2 (https=)
CN (1) CN109952372A (https=)
WO (1) WO2018050872A1 (https=)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11510871B2 (en) 2016-09-16 2022-11-29 Leukocare Ag Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation
US11166915B2 (en) 2016-09-16 2021-11-09 Leukocare Ag Method for obtaining efficient viral vector-based compositions for vaccination or gene therapy
KR102646145B1 (ko) 2018-05-31 2024-03-11 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 모공 축소용 조성물
CN112770812A (zh) * 2018-07-24 2021-05-07 沃雅戈治疗公司 产生基因治疗制剂的系统和方法
KR102058961B1 (ko) 2018-07-28 2019-12-24 주식회사 엑소코바이오 엑소좀의 동결건조 방법
KR102163806B1 (ko) * 2018-07-30 2020-10-07 주식회사 엑소코바이오 줄기세포 유래의 엑소좀을 유효성분으로 포함하는 피지분비 감소용 조성물
KR102288367B1 (ko) * 2018-11-15 2021-08-11 주식회사 바이오앱 식물체에서 바이러스-유사 입자를 발현하는 재조합 벡터 및 이를 이용한 써코바이러스-유사 입자를 포함하는 백신 조성물의 제조방법
CN112138153B (zh) * 2019-06-28 2022-08-23 怡道生物科技(苏州)有限公司 一种重组带状疱疹疫苗组合物及其用途
WO2021028559A1 (en) 2019-08-14 2021-02-18 Leukocare Ag Method for obtaining efficient compositions comprising viral vectors for vaccination or gene therapy
WO2021243264A2 (en) * 2020-05-28 2021-12-02 Lonza Ltd Formulations for viral vectors
WO2024077052A1 (en) * 2022-10-04 2024-04-11 Emergent Product Development Gaithersburg Inc. Novel vsv virus formulations
CN117065720B (zh) * 2023-07-21 2025-08-22 湖南新九方科技有限公司 一种热解生物炭吸附材料及其制备方法和应用
WO2025125222A1 (en) * 2023-12-11 2025-06-19 Leukocare Ag Compositions comprising viruses, viral vectors or virus-like particles
CN119548638B (zh) * 2025-01-21 2025-10-24 金宇保灵生物药品有限公司 一种活疫苗耐热保护剂及其制备方法和应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102188701A (zh) * 2010-03-12 2011-09-21 上海泽润生物科技有限公司 一种磷酸铝佐剂及其制备方法
CN103620025A (zh) * 2011-06-28 2014-03-05 白血球保健股份有限公司 病毒或细菌的新型稳定方法
CN105002190A (zh) * 2013-12-03 2015-10-28 北京康乐卫士生物技术股份有限公司 11型重组人乳头瘤病毒病毒样颗粒及其制备方法
CN105636609A (zh) * 2013-10-25 2016-06-01 白血球保健股份有限公司 一种新颖的生产稳定疫苗的方法

Family Cites Families (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3718889A1 (de) 1987-06-05 1988-12-22 Behringwerke Ag Verfahren zur herstellung einer loesung hoher spezifischer volumenaktivitaet von einem protein mit gewebe-plasminogenaktivator (t-pa)-aktivitaet, loesung, enthaltend protein mit t-pa-aktivitaet und verwendung der loesung in der human- und veterinaermedizin
GB9022545D0 (en) 1990-10-17 1990-11-28 Wellcome Found Culture medium
DE19508192A1 (de) 1995-03-09 1996-09-12 Behringwerke Ag Stabile Transglutaminasepräparate und Verfahren zu ihrer Herstellung
US6689600B1 (en) 1998-11-16 2004-02-10 Introgen Therapeutics, Inc. Formulation of adenovirus for gene therapy
MXPA05010555A (es) 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
WO2005066333A1 (en) * 2003-12-30 2005-07-21 Aventis Pasteur, Inc. Stabilizing compositions for recombinant viruses
BRPI0511764B8 (pt) 2004-06-01 2021-05-25 Avigen Inc método de prevenção de agregação de vírions de vírus adeno-associado recombinante (raav) em uma preparação purificada de virions raav
CA2576519C (en) 2004-08-17 2013-05-21 Regeneron Pharmaceuticals, Inc. Il-1 antagonist formulations
KR101357685B1 (ko) 2005-11-21 2014-02-06 사노피 파스퇴르 리미티드 / 사노피 파스퇴르 리미떼 재조합 바이러스용 안정화 제형
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
EP1834651A1 (en) * 2006-03-15 2007-09-19 Universiteit Gent Compositions and methods for veterinary vaccination
EP1854478A1 (en) * 2006-05-12 2007-11-14 Cytos Biotechnology AG Nicotine-carrier vaccine formulation
GB0715723D0 (en) 2007-08-11 2007-09-19 Ark Therapeutics Ltd Formulation
EP2143440A1 (fr) * 2008-07-09 2010-01-13 Sanofi Pasteur Agent stabilisant et composition vaccinale comprenant un ou plusieurs flavivirus vivants atténués
US7998488B2 (en) 2008-11-14 2011-08-16 Baxter International Inc. Vaccine formulations and uses thereof
EP2236520A1 (en) 2009-03-31 2010-10-06 Leukocare Ag Stabilizing composition for immobilized biomolecules
ES2661215T3 (es) * 2009-05-20 2018-03-28 Aeras Composiciones víricas; inmunógenas; secadas por pulverización; estables
US8557253B2 (en) 2009-10-07 2013-10-15 Sanofi Pasteur Sa Stabilizing excipient for inactivated whole virus vaccine
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
JP5798356B2 (ja) 2011-04-06 2015-10-21 一般財団法人化学及血清療法研究所 新規インフルエンザワクチン安定化剤
EP2699265B1 (en) 2011-04-20 2019-10-16 Sandoz AG STABLE PHARMACEUTICAL LIQUID FORMULATIONS OF THE FUSION PROTEIN TNFR:Fc
RU2610174C2 (ru) * 2011-06-24 2017-02-08 Мерк Шарп И Доум Корп. Вакцинные составы против вируса папилломы человека (hpv), содержащие алюминиевый адъювант, и способы их получения
EP2726495B1 (en) 2011-06-28 2019-03-06 Leukocare Ag Method for preventing the unfolding of a (poly)peptide and/or inducing the (re-)folding of a (poly)peptide
RU2654567C2 (ru) 2011-10-11 2018-05-21 Дженентек, Инк. Улучшенная сборка биспецифических антител
CN108771655A (zh) 2011-10-28 2018-11-09 诚信生物公司 含有氨基酸的蛋白质制剂
IN2015MN00038A (https=) 2012-06-25 2015-10-16 Emergent Product Dev Gaithersburg Inc
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
BR112015017307A2 (pt) 2013-03-14 2017-11-21 Abbvie Inc composições de espécies com baixa acidez e métodos para produção e uso das mesmas
KR20160030963A (ko) 2013-07-11 2016-03-21 시노팜 타이완 리미티드 황산화 올리고당을 검출하기 위한 분석 방법
WO2015040234A1 (en) 2013-09-23 2015-03-26 Crucell Holland B.V. Adenovirus formulations
WO2015140751A1 (en) 2014-03-21 2015-09-24 Boreal Invest Terminal nanofiltration of solubilized protein compositions for removal of immunogenic aggregates
KR102507483B1 (ko) * 2014-12-01 2023-03-07 트랜스진 안정한 액체 백시니아 바이러스 제제
KR20190053908A (ko) 2016-09-16 2019-05-20 로이코케어 아게 가공 동안 바이오 의약품의 안정화를 위한 신규한 방법
US20190256551A1 (en) 2016-09-16 2019-08-22 Leukocare Ag A novel method of producing a liquid biopharmaceutical drug product
US11510871B2 (en) 2016-09-16 2022-11-29 Leukocare Ag Method for producing low viscous and highly concentrated biopharmaceutical drug products in liquid formulation
US11166915B2 (en) 2016-09-16 2021-11-09 Leukocare Ag Method for obtaining efficient viral vector-based compositions for vaccination or gene therapy

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102188701A (zh) * 2010-03-12 2011-09-21 上海泽润生物科技有限公司 一种磷酸铝佐剂及其制备方法
CN103620025A (zh) * 2011-06-28 2014-03-05 白血球保健股份有限公司 病毒或细菌的新型稳定方法
CN105636609A (zh) * 2013-10-25 2016-06-01 白血球保健股份有限公司 一种新颖的生产稳定疫苗的方法
CN105002190A (zh) * 2013-12-03 2015-10-28 北京康乐卫士生物技术股份有限公司 11型重组人乳头瘤病毒病毒样颗粒及其制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
杨明: "微囊、微球的质量评价", 《中药药剂学》 *
杨明: "微囊、微球的质量评价", 《中药药剂学》, 31 July 2016 (2016-07-31), pages 390 *

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WO2018050872A1 (en) 2018-03-22
JP2019531288A (ja) 2019-10-31
US11166915B2 (en) 2021-11-09
JP7051132B2 (ja) 2022-04-11
US12350375B2 (en) 2025-07-08
EP3512939A1 (en) 2019-07-24
US20220202717A1 (en) 2022-06-30
US20190269618A1 (en) 2019-09-05

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