CN115176037A - 病毒清除性能的评价方法 - Google Patents

病毒清除性能的评价方法 Download PDF

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Publication number
CN115176037A
CN115176037A CN202180017160.5A CN202180017160A CN115176037A CN 115176037 A CN115176037 A CN 115176037A CN 202180017160 A CN202180017160 A CN 202180017160A CN 115176037 A CN115176037 A CN 115176037A
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China
Prior art keywords
virus
solution
capsid
viral
particles
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Pending
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CN202180017160.5A
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English (en)
Chinese (zh)
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粥川太贵
柳田恒一郎
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Asahi Kasei Life Sciences Co.,Ltd.
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Asahi Kasei Medical Co Ltd
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Publication of CN115176037A publication Critical patent/CN115176037A/zh
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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)
CN202180017160.5A 2020-02-28 2021-02-26 病毒清除性能的评价方法 Pending CN115176037A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2020-033114 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 (1)

Publication Number Publication Date
CN115176037A true CN115176037A (zh) 2022-10-11

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Family Applications (1)

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CN202180017160.5A Pending CN115176037A (zh) 2020-02-28 2021-02-26 病毒清除性能的评价方法

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113122501A (zh) * 2019-12-30 2021-07-16 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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12203914B2 (en) * 2020-11-12 2025-01-21 Sartorius Bioanalytical Instruments, Inc. Viral clearance evaluation for biological medical product preparation processes

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011130119A2 (en) * 2010-04-14 2011-10-20 Millipore Corporation Methods of producing high titer, high purity virus stocks and methods of use thereof
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 (6)

* 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
SG11201405185PA (en) * 2012-03-13 2014-10-30 Emd Millipore Corp Use of centrifugation-aided infection to increase virus titer
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
WO2011130119A2 (en) * 2010-04-14 2011-10-20 Millipore Corporation Methods of producing high titer, high purity virus stocks and methods of use thereof
CN102985536A (zh) * 2010-04-14 2013-03-20 Emd密理博公司 生产高效价、高纯度的病毒母液的方法及使用其的方法
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
LIMING SHI等: "real time quantitative PCR as a method to evaluate xenotropic murine leukemia virus removal during pharmaceutical protein purification", PROCESS SCIENCES, 21 April 2004 (2004-04-21), pages 1 - 13 *
佚名: "Technical report No.47 preparation of virus spikes used for virus clearance studies", PARENTERAL DRUG ASSOCIATION, 1 February 2010 (2010-02-01), pages 1 - 61 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113122501A (zh) * 2019-12-30 2021-07-16 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
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

Also Published As

Publication number Publication date
JP7390466B2 (ja) 2023-12-01
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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Effective date of registration: 20250715

Address after: Tokyo, Japan

Applicant after: Asahi Kasei Life Sciences Co.,Ltd.

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Country or region before: Japan