JP6465800B2 - エンベロープウイルスを不活化するための方法および組成物 - Google Patents

エンベロープウイルスを不活化するための方法および組成物 Download PDF

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JP6465800B2
JP6465800B2 JP2015526635A JP2015526635A JP6465800B2 JP 6465800 B2 JP6465800 B2 JP 6465800B2 JP 2015526635 A JP2015526635 A JP 2015526635A JP 2015526635 A JP2015526635 A JP 2015526635A JP 6465800 B2 JP6465800 B2 JP 6465800B2
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recombinant protein
surfactant
concentration
sulfobetaine
zwitterionic surfactant
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JP2015525572A5 (enExample
JP2015525572A (ja
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コンリー,リン,エドワード
タオ,インイン
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Biogen MA Inc
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Biogen MA Inc
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    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • 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
    • C12N2710/16011—Herpesviridae
    • C12N2710/16711—Varicellovirus, e.g. human herpesvirus 3, Varicella Zoster, pseudorabies
    • C12N2710/16761—Methods of inactivation or attenuation
    • C12N2710/16763—Methods of inactivation or attenuation by chemical treatment
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/13011—Gammaretrovirus, e.g. murine leukeamia virus
    • C12N2740/13061—Methods of inactivation or attenuation
    • C12N2740/13063—Methods of inactivation or attenuation by chemical treatment

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2015526635A 2012-08-06 2013-08-06 エンベロープウイルスを不活化するための方法および組成物 Active JP6465800B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261680039P 2012-08-06 2012-08-06
US61/680,039 2012-08-06
PCT/US2013/053781 WO2014025771A2 (en) 2012-08-06 2013-08-06 Methods and compositions for inactivating enveloped viruses

Related Child Applications (1)

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JP2018190622A Division JP6833788B2 (ja) 2012-08-06 2018-10-09 エンベロープウイルスを不活化するための方法および組成物

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JP2015525572A JP2015525572A (ja) 2015-09-07
JP2015525572A5 JP2015525572A5 (enExample) 2016-09-29
JP6465800B2 true JP6465800B2 (ja) 2019-02-06

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US (2) US10188732B2 (enExample)
EP (2) EP2879691B1 (enExample)
JP (2) JP6465800B2 (enExample)
DK (1) DK2879691T3 (enExample)
WO (1) WO2014025771A2 (enExample)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10188732B2 (en) 2012-08-06 2019-01-29 Biogen Ma Inc. Methods and compositions for inactivating enveloped viruses
US11414712B2 (en) 2014-09-17 2022-08-16 Helixbind, Inc. Methods and devices for detecting and identifying microorganisms
AR102198A1 (es) 2014-10-09 2017-02-08 Regeneron Pharma Proceso para reducir partículas subvisibles en una formulación farmacéutica
WO2017147267A1 (en) * 2016-02-24 2017-08-31 Bio-Rad Laboratories, Inc. Methods and compositions for fluorescence detection
AU2017312785B2 (en) 2016-08-16 2024-10-10 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
KR102759512B1 (ko) 2016-10-25 2025-02-03 리제너론 파아마슈티컬스, 인크. 크로마토그래피 데이터 분석을 위한 방법 및 시스템
EP3446710A1 (en) * 2017-08-25 2019-02-27 Glenmark Pharmaceuticals S.A. Methods of inactivating viral contaminants
CA3075853A1 (en) * 2017-09-18 2019-03-21 Bayer Healthcare Llc Methods of inactivation of viruses using n-methylglucamide and its derivatives
WO2019060062A1 (en) 2017-09-19 2019-03-28 Regeneron Pharmaceuticals Inc. METHODS OF REDUCING PARTICLE FORMATION AND COMPOSITIONS FORMED THEREFROM
WO2019086463A1 (en) 2017-10-30 2019-05-09 Baxalta GmbH Environmentally compatible detergents for inactivation of lipid-enveloped viruses
TWI919355B (zh) 2018-07-02 2026-03-21 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
PE20211140A1 (es) 2018-11-15 2021-06-25 Bayer Healthcare Llc Metodos de inactivacion virica para la fabricacion continua de anticuerpos
EA202192422A1 (ru) 2019-03-05 2021-12-09 Ридженерон Фармасьютикалз, Инк. Человеческий сывороточный альбумин в составах
KR20210142670A (ko) 2019-03-19 2021-11-25 암젠 인크 바이러스 불활성화를 위한 대체 세제
CN110424030B (zh) * 2019-08-30 2020-06-30 广州三孚新材料科技股份有限公司 无氰碱性电镀铜液及其制备和在挠性印刷线路板中的应用
US20230183656A1 (en) * 2020-05-14 2023-06-15 Merck Patent Gmbh Methods and compositions for purifying adeno associated virus particles or adenoviruses
US11643641B2 (en) 2021-03-04 2023-05-09 Malireddy S. Reddy Prevention of viral transmission by naked genetic material
WO2022268811A1 (en) 2021-06-21 2022-12-29 Uniqure Biopharma B.V. Improved lysis procedures
WO2024115344A1 (en) 2022-11-29 2024-06-06 Merck Patent Gmbh Method for inactivating enveloped viruses

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE242716C (enExample)
DD242716A3 (de) * 1981-08-28 1987-02-11 Adw Der Ddr Inst F Chem Techno Verfahren zur herstellung von gereinigten antigenen bzw. biopraeparaten
DE3704550A1 (de) * 1987-02-13 1988-08-25 Behringwerke Ag Verfahren zur inaktivierung huellhaltiger viren in mittels einer zelle in vitro hergestellten protein-praeparationen
GB8927546D0 (en) * 1989-12-06 1990-02-07 Ciba Geigy Process for the production of biologically active tgf-beta
US5314917A (en) * 1991-03-22 1994-05-24 E. B. Michaels Research Associates, Inc. Method for inactivating enveloped viruses and sperm
FR2805163A1 (fr) * 2000-02-21 2001-08-24 Pf Medicament Utilisation d'un detergent de type zwittergent pour la preparation d'une composition pharmaceutique destinee a etre administree par voie nasale
US6635679B2 (en) * 2001-05-14 2003-10-21 Akzo Nobel N.V. Methods and compositions for inactivating viruses
CN1901935A (zh) 2003-12-30 2007-01-24 惠氏公司 具有改进耐受性的免疫原组合物中的疏水性蛋白调配物
ES2377884T3 (es) * 2005-11-04 2012-04-02 Novartis Vaccines And Diagnostics S.R.L. Vacunas contra la gripe que incluyen combinaciones de adyuvantes particulados e inmunopotenciadores
EP1970440A1 (en) * 2007-03-06 2008-09-17 Qiagen GmbH Polymerase stabilization by ionic detergents
BR112013015113B1 (pt) 2010-12-15 2023-01-31 Takeda Pharmaceutical Company Limited Método de inativar um vírus contendo envelope lipídico
GB201216121D0 (en) * 2012-09-10 2012-10-24 Novartis Ag Sample quantification by disc centrifugation
US10188732B2 (en) 2012-08-06 2019-01-29 Biogen Ma Inc. Methods and compositions for inactivating enveloped viruses

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Publication number Publication date
WO2014025771A3 (en) 2014-04-17
US10188732B2 (en) 2019-01-29
US10702603B2 (en) 2020-07-07
WO2014025771A2 (en) 2014-02-13
EP3456352A1 (en) 2019-03-20
JP6833788B2 (ja) 2021-02-24
JP2015525572A (ja) 2015-09-07
DK2879691T3 (da) 2019-06-11
JP2019037234A (ja) 2019-03-14
EP2879691B1 (en) 2019-03-27
US20150306223A1 (en) 2015-10-29
EP2879691A2 (en) 2015-06-10
US20190175738A1 (en) 2019-06-13

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