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
Links
Classifications
-
- 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
-
- 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
- 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
-
- 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
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)
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)
| 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)
| 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)
| 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 |
-
2019
- 2019-05-30 US US16/426,124 patent/US12152281B2/en active Active
-
2020
- 2020-05-22 AU AU2020283526A patent/AU2020283526A1/en active Pending
- 2020-05-22 CA CA3140145A patent/CA3140145A1/en active Pending
- 2020-05-22 IL IL288404A patent/IL288404B2/en unknown
- 2020-05-22 JP JP2021569884A patent/JP7755490B2/ja active Active
- 2020-05-22 KR KR1020217038299A patent/KR20220016071A/ko active Pending
- 2020-05-22 EP EP20812945.2A patent/EP3976803A4/en active Pending
- 2020-05-22 WO PCT/US2020/034146 patent/WO2020242913A1/en not_active Ceased
- 2020-05-22 BR BR112021024020A patent/BR112021024020A2/pt unknown
- 2020-05-22 CN CN202080038925.9A patent/CN113874514A/zh active Pending
-
2024
- 2024-11-07 US US18/940,233 patent/US20250163519A1/en active Pending
-
2025
- 2025-06-13 JP JP2025099242A patent/JP2025123368A/ja active Pending
Patent Citations (7)
| 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)
| 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 |