JP7612001B2 - ウイルスクリアランス試験の方法 - Google Patents

ウイルスクリアランス試験の方法 Download PDF

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Publication number
JP7612001B2
JP7612001B2 JP2023509329A JP2023509329A JP7612001B2 JP 7612001 B2 JP7612001 B2 JP 7612001B2 JP 2023509329 A JP2023509329 A JP 2023509329A JP 2023509329 A JP2023509329 A JP 2023509329A JP 7612001 B2 JP7612001 B2 JP 7612001B2
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Japan
Prior art keywords
virus
solution
removal filter
protein
flow path
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JP2023509329A
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Japanese (ja)
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JPWO2022203044A1 (https=
Inventor
浩伸 白瀧
エブナー ユルゲン
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Asahi Kasei Medical Co Ltd
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Asahi Kasei Medical Co Ltd
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D65/00—Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
    • B01D65/10—Testing of membranes or membrane apparatus; Detecting or repairing leaks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/33—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
    • G01N27/04—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
    • G01N27/06—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14311—Parvovirus, e.g. minute virus of mice
    • C12N2750/14321—Viruses as such, e.g. new isolates, mutants or their genomic sequences

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • Electrochemistry (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
JP2023509329A 2021-03-26 2022-03-25 ウイルスクリアランス試験の方法 Active JP7612001B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2021053527 2021-03-26
JP2021053527 2021-03-26
PCT/JP2022/014401 WO2022203044A1 (ja) 2021-03-26 2022-03-25 ウイルスクリアランス試験の方法

Publications (2)

Publication Number Publication Date
JPWO2022203044A1 JPWO2022203044A1 (https=) 2022-09-29
JP7612001B2 true JP7612001B2 (ja) 2025-01-10

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ID=83397485

Family Applications (1)

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JP2023509329A Active JP7612001B2 (ja) 2021-03-26 2022-03-25 ウイルスクリアランス試験の方法

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US (1) US20240175098A1 (https=)
EP (1) EP4317460B1 (https=)
JP (1) JP7612001B2 (https=)
WO (1) WO2022203044A1 (https=)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018075716A1 (en) 2016-10-21 2018-04-26 Bayer Healthcare Llc Validation of continuous viral clearance

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001014047A1 (en) 1999-08-20 2001-03-01 Asahi Kasei Kabushiki Kaisha Filter membranes for physiologically active substances
BR112012026095A2 (pt) 2010-04-14 2015-09-15 Emd Millipore Corp métodos de produção de estoques de vírus de alta pureza e altos títulos e métodos de uso dos mesmos.
US9809800B2 (en) 2012-11-22 2017-11-07 Asahi Kasei Medical Co., Ltd. Method for producing parvovirus having high infectivity titer
IL301774A (en) * 2020-10-02 2023-05-01 Regeneron Pharma Continuous retentive filtering of viruses

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018075716A1 (en) 2016-10-21 2018-04-26 Bayer Healthcare Llc Validation of continuous viral clearance

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
Biotechnol. Bioeng.，2017年01月，Vol.114, No.1，p.21-32
Biotechnol. Progress，2020年10月05日，Vol.37，e3088,p.1-10
MATEC Web of Conferences，2019年，Vol.268，01003，https://doi.org/10.1051/matecconf/201926801003
Pharmaceutical Technology，2019年01月，p.38-40

Also Published As

Publication number Publication date
US20240175098A1 (en) 2024-05-30
JPWO2022203044A1 (https=) 2022-09-29
EP4317460A4 (en) 2024-10-23
WO2022203044A1 (ja) 2022-09-29
EP4317460B1 (en) 2025-12-31
EP4317460A1 (en) 2024-02-07

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