AU2020283526A1 - Ultra-high-precision viral vector assay - Google Patents

Ultra-high-precision viral vector assay Download PDF

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Publication number
AU2020283526A1
AU2020283526A1 AU2020283526A AU2020283526A AU2020283526A1 AU 2020283526 A1 AU2020283526 A1 AU 2020283526A1 AU 2020283526 A AU2020283526 A AU 2020283526A AU 2020283526 A AU2020283526 A AU 2020283526A AU 2020283526 A1 AU2020283526 A1 AU 2020283526A1
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AU
Australia
Prior art keywords
cells
replicate
normal human
virus
human cells
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AU2020283526A
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English (en)
Inventor
Minna HASSINEN
Jenni MYKKANNEN
Nigel Parker
Hanna Peltonen
Seppo Yla-Herttuala
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Ferring Ventures Ltd
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Ferring Ventures Ltd
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Publication of AU2020283526A1 publication Critical patent/AU2020283526A1/en
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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
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • C12Q1/701—Specific hybridization probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0091—Purification or manufacturing processes for gene therapy compositions
    • 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
    • C12Q1/686—Polymerase chain reaction [PCR]
    • 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
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • 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
    • C12N2710/10311—Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10341—Use of virus, viral particle or viral elements as a vector
    • C12N2710/10343—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
    • 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
    • C12Q2531/00—Reactions of nucleic acids characterised by
    • C12Q2531/10—Reactions of nucleic acids characterised by the purpose being amplify/increase the copy number of target nucleic acid
    • C12Q2531/113—PCR
    • 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2020283526A 2019-05-30 2020-05-22 Ultra-high-precision viral vector assay Pending AU2020283526A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16/426,124 2019-05-30
US16/426,124 US12152281B2 (en) 2019-05-30 2019-05-30 Gene therapy vector contamination assay
PCT/US2020/034146 WO2020242913A1 (en) 2019-05-30 2020-05-22 Ultra-high-precision viral vector assay

Publications (1)

Publication Number Publication Date
AU2020283526A1 true AU2020283526A1 (en) 2021-12-23

Family

ID=67984844

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020283526A Pending AU2020283526A1 (en) 2019-05-30 2020-05-22 Ultra-high-precision viral vector assay

Country Status (10)

Country Link
US (2) US12152281B2 (https=)
EP (1) EP3976803A4 (https=)
JP (2) JP7755490B2 (https=)
KR (1) KR20220016071A (https=)
CN (1) CN113874514A (https=)
AU (1) AU2020283526A1 (https=)
BR (1) BR112021024020A2 (https=)
CA (1) CA3140145A1 (https=)
IL (1) IL288404B2 (https=)
WO (1) WO2020242913A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12152281B2 (en) 2019-05-30 2024-11-26 Trizell Ltd. Gene therapy vector contamination assay
CN111041131B (zh) * 2020-03-16 2020-07-10 广东永诺医疗科技有限公司 基于微滴式数字pcr的eb病毒检测试剂盒

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6410010B1 (en) * 1992-10-13 2002-06-25 Board Of Regents, The University Of Texas System Recombinant P53 adenovirus compositions
US6020191A (en) 1997-04-14 2000-02-01 Genzyme Corporation Adenoviral vectors capable of facilitating increased persistence of transgene expression
EP1238091A2 (en) * 1999-12-14 2002-09-11 Genovo, Incorporated Methods and compositions for the manufacture of replication incompetent adenovirus
WO2003104476A2 (en) 2002-06-07 2003-12-18 Novartis Ag Assay to detect replication competent viruses
US20080193484A1 (en) 2004-10-25 2008-08-14 Biogen Idec Ma Inc. Novel Methods for Producing Adenoviral Vector Preparations with Reduced Replication-Competent Adenovirus Contamination and Novel Adenoviral Vectors and Preparations
WO2008079354A2 (en) 2006-12-22 2008-07-03 Schering Corporation Methods of detecting replication competent adenovirus
CN102884196B (zh) 2010-04-01 2015-05-06 肖卫东 重组病毒载体的结构及其制备
EP3181704B1 (en) * 2010-12-27 2021-01-27 Abbott Molecular Inc. Quantitating high titer samples by digital pcr
CN102134613B (zh) * 2010-12-31 2013-01-30 中国人民解放军第三军医大学 重组慢病毒滴度的检测方法
CA2871774C (en) * 2012-04-26 2021-05-18 Sentient Lifesciences, Inc. Use of n-acetylcysteine amide in the treatment of disease and injury
CA2925942C (en) * 2013-10-01 2022-05-03 Texcell Detection of rare microbiological nucleic acids
US11193176B2 (en) * 2013-12-31 2021-12-07 Bio-Rad Laboratories, Inc. Method for detecting and quantifying latent retroviral RNA species
EP3387138B1 (en) 2015-12-11 2022-01-26 The Trustees Of The University Of Pennsylvania Scalable purification method for aav9
RS67367B1 (sr) * 2016-04-14 2025-11-28 Ferring Ventures Ltd Bioreaktor sa fiksiranim slojem sa pumpom/sistemom creva sa konstantnim protokom
GB2549799A (en) * 2016-04-29 2017-11-01 Nat Univ Ireland Galway A multiplex assay for the sensitive and specific detection and differentiation of Clostridium difficile
JP7483373B2 (ja) * 2016-07-29 2024-05-15 ジュノー セラピューティクス インコーポレイテッド 複製可能ウイルスの存在または非存在を評価するための方法
CN107794291A (zh) * 2017-04-10 2018-03-13 中山大学 一种抗新加坡石斑鱼虹彩病毒的药物筛选方法
CN108570449A (zh) * 2018-05-17 2018-09-25 石河子大学 一种带有自发性kshv裂解复制的神经元细胞的构建方法
US12152281B2 (en) 2019-05-30 2024-11-26 Trizell Ltd. Gene therapy vector contamination assay

Also Published As

Publication number Publication date
WO2020242913A1 (en) 2020-12-03
JP2022534483A (ja) 2022-08-01
IL288404B1 (en) 2024-11-01
CA3140145A1 (en) 2020-12-03
EP3976803A4 (en) 2023-11-22
US12152281B2 (en) 2024-11-26
KR20220016071A (ko) 2022-02-08
US20250163519A1 (en) 2025-05-22
IL288404A (en) 2022-01-01
JP2025123368A (ja) 2025-08-22
CN113874514A (zh) 2021-12-31
EP3976803A1 (en) 2022-04-06
JP7755490B2 (ja) 2025-10-16
IL288404B2 (en) 2025-03-01
BR112021024020A2 (pt) 2022-04-12
US20190292609A1 (en) 2019-09-26

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