JP7755490B2 - 超高精度ウイルスベクターアッセイ - Google Patents

超高精度ウイルスベクターアッセイ

Info

Publication number
JP7755490B2
JP7755490B2 JP2021569884A JP2021569884A JP7755490B2 JP 7755490 B2 JP7755490 B2 JP 7755490B2 JP 2021569884 A JP2021569884 A JP 2021569884A JP 2021569884 A JP2021569884 A JP 2021569884A JP 7755490 B2 JP7755490 B2 JP 7755490B2
Authority
JP
Japan
Prior art keywords
cells
normal human
assay
viral
human cells
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2021569884A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022534483A (ja
Inventor
イェンニ ミュッカネン,
ハンナ ペルトネン,
ミンナ ハッシネン,
セッポ イラ-ヘルットゥアラ,
ナイジェル パーカー,
Original Assignee
フェリング ベンチャーズ リミテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by フェリング ベンチャーズ リミテッド filed Critical フェリング ベンチャーズ リミテッド
Publication of JP2022534483A publication Critical patent/JP2022534483A/ja
Priority to JP2025099242A priority Critical patent/JP2025123368A/ja
Application granted granted Critical
Publication of JP7755490B2 publication Critical patent/JP7755490B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0091Purification or manufacturing processes for gene therapy compositions
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844Nucleic acid amplification reactions
    • C12Q1/686Polymerase chain reaction [PCR]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • C12Q1/701Specific hybridization probes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/10011Adenoviridae
    • C12N2710/10311Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10341Use of virus, viral particle or viral elements as a vector
    • C12N2710/10343Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2531/00Reactions of nucleic acids characterised by
    • C12Q2531/10Reactions of nucleic acids characterised by the purpose being amplify/increase the copy number of target nucleic acid
    • C12Q2531/113PCR
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/106Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/156Polymorphic or mutational markers

Landscapes

  • 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)
  • Medicinal Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
JP2021569884A 2019-05-30 2020-05-22 超高精度ウイルスベクターアッセイ Active JP7755490B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025099242A JP2025123368A (ja) 2019-05-30 2025-06-13 超高精度ウイルスベクターアッセイ

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025099242A Division JP2025123368A (ja) 2019-05-30 2025-06-13 超高精度ウイルスベクターアッセイ

Publications (2)

Publication Number Publication Date
JP2022534483A JP2022534483A (ja) 2022-08-01
JP7755490B2 true JP7755490B2 (ja) 2025-10-16

Family

ID=67984844

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021569884A Active JP7755490B2 (ja) 2019-05-30 2020-05-22 超高精度ウイルスベクターアッセイ
JP2025099242A Pending JP2025123368A (ja) 2019-05-30 2025-06-13 超高精度ウイルスベクターアッセイ

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025099242A Pending JP2025123368A (ja) 2019-05-30 2025-06-13 超高精度ウイルスベクターアッセイ

Country Status (10)

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

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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003516743A (ja) 1999-12-14 2003-05-20 ジェノボ, インコーポレイテッド 複製不能アデノウイルスの製造のための方法および組成物
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
WO2011123088A1 (en) 2010-04-01 2011-10-06 Weidong Xiao Compositions and methods for the production of recombinant virus vectors
US20150184256A1 (en) 2013-12-31 2015-07-02 Raindance Technologies, Inc. System and method for detection of rna species
JP2016531561A (ja) 2013-10-01 2016-10-13 テクセル 希少な微生物学的核酸の検出
WO2018023094A1 (en) 2016-07-29 2018-02-01 Juno Therapeutics, Inc. Methods for assessing the presence or absence of replication competent virus

Family Cites Families (12)

* 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
WO2008079354A2 (en) 2006-12-22 2008-07-03 Schering Corporation Methods of detecting replication competent adenovirus
CA2965074A1 (en) * 2010-12-27 2012-07-05 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
US11098286B2 (en) 2015-12-11 2021-08-24 The Trustees Of The University Of Pennsylvania Scalable purification method for AAV9
HRP20251357T1 (hr) * 2016-04-14 2025-12-19 Ferring Ventures Ltd Bioreaktor s nepomičnim slojem i sustavom pumpe/cijevi konstantnog protoka
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
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

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003516743A (ja) 1999-12-14 2003-05-20 ジェノボ, インコーポレイテッド 複製不能アデノウイルスの製造のための方法および組成物
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
WO2011123088A1 (en) 2010-04-01 2011-10-06 Weidong Xiao Compositions and methods for the production of recombinant virus vectors
JP2016531561A (ja) 2013-10-01 2016-10-13 テクセル 希少な微生物学的核酸の検出
US20150184256A1 (en) 2013-12-31 2015-07-02 Raindance Technologies, Inc. System and method for detection of rna species
WO2018023094A1 (en) 2016-07-29 2018-02-01 Juno Therapeutics, Inc. Methods for assessing the presence or absence of replication competent virus

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Guiwei DONG et al.,Journal of Virological Methods,2018年,Vol. 265,pp. 59-65
Qiuchen LI et al.,BioMed Research International,2019年05月16日,Vol. 2019, Article ID 2750472,pp. 1-9

Also Published As

Publication number Publication date
BR112021024020A2 (pt) 2022-04-12
WO2020242913A1 (en) 2020-12-03
CA3140145A1 (en) 2020-12-03
US20190292609A1 (en) 2019-09-26
JP2022534483A (ja) 2022-08-01
IL288404B1 (en) 2024-11-01
EP3976803A4 (en) 2023-11-22
US20250163519A1 (en) 2025-05-22
KR20220016071A (ko) 2022-02-08
US12152281B2 (en) 2024-11-26
EP3976803A1 (en) 2022-04-06
IL288404A (en) 2022-01-01
JP2025123368A (ja) 2025-08-22
AU2020283526A1 (en) 2021-12-23
CN113874514A (zh) 2021-12-31
IL288404B2 (en) 2025-03-01

Similar Documents

Publication Publication Date Title
JP2025123368A (ja) 超高精度ウイルスベクターアッセイ
Greenberg et al. Identification of newly transcribed RNA
Quigley et al. Unbiased molecular analysis of T cell receptor expression using template‐switch anchored RT‐PCR
van den Bos et al. Quantification of aneuploidy in mammalian systems
Investigational Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs) guidance for industry
Haase et al. Replication control of autonomously replicating human sequences
Barbosa-Solomieu et al. Diagnosis of Ostreid herpesvirus 1 in fixed paraffin-embedded archival samples using PCR and in situ hybridisation
Jang et al. AdenoBuilder: A platform for the modular assembly of recombinant adenoviruses
Frascaroli et al. Distinct properties of human cytomegalovirus strains and the appropriate choice of strains for particular studies
Rathakrishnan et al. Isolation of porcine bone marrow cells and generation of recombinant African swine fever viruses
Frascaroli et al. Distinct properties of human cytomegalovirus strains and the appropriate choice of strains for particular studies
Nakayama et al. Preparation of intact nuclei for single-nucleus omics using frozen cell suspensions from mutant embryos of xenopus tropicalis
King et al. Recombinant baculovirus isolation
Camarda et al. Pulsed-field gel electrophoresis of Salmonella enterica
Sawtell et al. Herpes simplex virus mutant generation and dual-detection methods for gaining insight into latent/lytic cycles in vivo
Ruppach NGS-Based Viral Safety Testing for ATMPs: Mandatory or Just an Option?
Knott et al. Cell lines for vaccine production
Gowripalan et al. Cas9-Mediated Poxvirus Recombinant Recovery (CASPRR) for Fast Recovery of Recombinant Vaccinia Viruses
Broder et al. Design and construction of recombinant vaccinia viruses
Roy et al. Laser capture micro-dissection (LCM) of neonatal mouse forebrain for RNA isolation
Lednicky et al. High-fidelity PCR amplification of infectious copies of the complete simian virus 40 genome from plasmids and virus-infected cell lysates
CN120758460A (zh) 一种施马伦贝格病毒的假病毒及其应用
Evans Optimising producer cell line culture and transfection for improved viral vector manufacture
Morbeck et al. Blastocyst development in assisted reproductive technologies: a narrative review evaluating its role as a surrogate marker for pregnancy outcomes and live birth success
CN117143914A (zh) 一种高效的细胞系基因敲除方法

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20230519

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20240424

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240507

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20240806

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20241002

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241107

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20250213

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250613

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20250630

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20250908

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20251003

R150 Certificate of patent or registration of utility model

Ref document number: 7755490

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150