JP7390466B2 - ウイルスクリアランス性能の評価方法 - Google Patents

ウイルスクリアランス性能の評価方法 Download PDF

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Publication number
JP7390466B2
JP7390466B2 JP2022503376A JP2022503376A JP7390466B2 JP 7390466 B2 JP7390466 B2 JP 7390466B2 JP 2022503376 A JP2022503376 A JP 2022503376A JP 2022503376 A JP2022503376 A JP 2022503376A JP 7390466 B2 JP7390466 B2 JP 7390466B2
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Prior art keywords
virus
solution
capsid
particles
purified
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Japanese (ja)
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JPWO2021172573A1 (https=
Inventor
太貴 粥川
恒一郎 柳田
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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
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • 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
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/6851—Quantitative amplification
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
JP2022503376A 2020-02-28 2021-02-26 ウイルスクリアランス性能の評価方法 Active JP7390466B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2020033114 2020-02-28
JP2020033114 2020-02-28
PCT/JP2021/007566 WO2021172573A1 (ja) 2020-02-28 2021-02-26 ウイルスクリアランス性能の評価方法

Publications (2)

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JPWO2021172573A1 JPWO2021172573A1 (https=) 2021-09-02
JP7390466B2 true JP7390466B2 (ja) 2023-12-01

Family

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JP2022503376A Active JP7390466B2 (ja) 2020-02-28 2021-02-26 ウイルスクリアランス性能の評価方法

Country Status (5)

Country Link
US (1) US20230103302A1 (https=)
EP (1) EP4112735A4 (https=)
JP (1) JP7390466B2 (https=)
CN (1) CN115176037A (https=)
WO (1) WO2021172573A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113122501B (zh) * 2019-12-30 2023-06-16 重庆精准生物技术有限公司 适合大规模临床级病毒载体制备的培养基及其应用
US12203914B2 (en) * 2020-11-12 2025-01-21 Sartorius Bioanalytical Instruments, Inc. Viral clearance evaluation for biological medical product preparation processes

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523175A (ja) 2010-04-14 2013-06-17 イーエムディー・ミリポア・コーポレーション 高力価、高純度のウイルスストックの作製方法及びその使用方法
US20150166965A1 (en) 2012-03-13 2015-06-18 Emd Millipore Corporation Use of centrifugation-aided infection to increase virus titer
JP2016529908A (ja) 2013-09-10 2016-09-29 モックヴィー ソリューションズ， インコーポレイテッド 生成された溶液からのモックウイルス粒子の除去を定量するための方法およびキット

Family Cites Families (5)

* 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
JP6198278B2 (ja) * 2011-09-08 2017-09-20 ユニキュアー アイピー ビー．ブイ． Ａａｖ調製物からの混入ウイルスの除去
US9809800B2 (en) 2012-11-22 2017-11-07 Asahi Kasei Medical Co., Ltd. Method for producing parvovirus having high infectivity titer
WO2015156401A1 (ja) 2014-04-11 2015-10-15 旭化成メディカル株式会社 ウイルス除去膜
EP3141611A3 (en) * 2016-10-21 2017-05-10 Bayer Healthcare LLC Validation of continuous viral clearance

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013523175A (ja) 2010-04-14 2013-06-17 イーエムディー・ミリポア・コーポレーション 高力価、高純度のウイルスストックの作製方法及びその使用方法
US20150166965A1 (en) 2012-03-13 2015-06-18 Emd Millipore Corporation Use of centrifugation-aided infection to increase virus titer
JP2016529908A (ja) 2013-09-10 2016-09-29 モックヴィー ソリューションズ， インコーポレイテッド 生成された溶液からのモックウイルス粒子の除去を定量するための方法およびキット

Also Published As

Publication number Publication date
CN115176037A (zh) 2022-10-11
WO2021172573A1 (ja) 2021-09-02
EP4112735A1 (en) 2023-01-04
EP4112735A4 (en) 2023-09-06
JPWO2021172573A1 (https=) 2021-09-02
US20230103302A1 (en) 2023-04-06

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