CN113874514A - 超高精度病毒载体测定法 - Google Patents

超高精度病毒载体测定法 Download PDF

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CN113874514A
CN113874514A CN202080038925.9A CN202080038925A CN113874514A CN 113874514 A CN113874514 A CN 113874514A CN 202080038925 A CN202080038925 A CN 202080038925A CN 113874514 A CN113874514 A CN 113874514A
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cells
viral
normal human
human cells
assay
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J·迈克南
H·佩尔托宁
M·哈西宁
S·伊拉-赫图拉
N·帕克尔
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Trizell Ltd
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    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
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    • C12Q1/701Specific hybridization probes
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    • A61K48/0091Purification or manufacturing processes for gene therapy compositions
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    • 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
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    • C12N2710/10011Adenoviridae
    • C12N2710/10311Mastadenovirus, e.g. human or simian adenoviruses
    • C12N2710/10341Use of virus, viral particle or viral elements as a vector
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    • 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
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    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/106Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
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    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/156Polymorphic or mutational markers

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  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
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CN202080038925.9A 2019-05-30 2020-05-22 超高精度病毒载体测定法 Pending CN113874514A (zh)

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

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CN113874514A true CN113874514A (zh) 2021-12-31

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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
WO2003104476A2 (en) * 2002-06-07 2003-12-18 Novartis Ag Assay to detect replication competent viruses
CN102134613A (zh) * 2010-12-31 2011-07-27 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
EP2659002A1 (en) * 2010-12-27 2013-11-06 Ibis Biosciences, Inc. Quantitating high titer samples by digital pcr
GB201607596D0 (en) * 2016-04-29 2016-06-15 Nat Univ Ireland 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
CN109072252A (zh) * 2016-04-14 2018-12-21 崔泽尔有限公司 大规模pei介导的质粒转染

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
AU1817401A (en) * 1999-12-14 2001-06-25 Genovo, Incorporated Methods and compositions for the manufacture of replication incompetent adenovirus
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
EP2553105B1 (en) 2010-04-01 2014-12-17 Weidong Xiao Compositions and methods for the production of recombinant virus vectors
CA2871774C (en) * 2012-04-26 2021-05-18 Sentient Lifesciences, Inc. Use of n-acetylcysteine amide in the treatment of disease and injury
WO2015049278A1 (en) 2013-10-01 2015-04-09 Texcell Detection of rare microbiological nucleic acids
WO2015103367A1 (en) * 2013-12-31 2015-07-09 Raindance Technologies, Inc. System and method for detection of rna species
US11098286B2 (en) 2015-12-11 2021-08-24 The Trustees Of The University Of Pennsylvania Scalable purification method for AAV9
CA3031994A1 (en) * 2016-07-29 2018-02-01 Juno Therapeutics, Inc. Methods for assessing the presence or absence of replication competent virus
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
WO2003104476A2 (en) * 2002-06-07 2003-12-18 Novartis Ag Assay to detect replication competent viruses
EP2659002A1 (en) * 2010-12-27 2013-11-06 Ibis Biosciences, Inc. Quantitating high titer samples by digital pcr
CN102134613A (zh) * 2010-12-31 2011-07-27 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
CN109072252A (zh) * 2016-04-14 2018-12-21 崔泽尔有限公司 大规模pei介导的质粒转染
GB201607596D0 (en) * 2016-04-29 2016-06-15 Nat Univ Ireland 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

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
GABOR ARTUR DUNAY等: "Assement of the HIV-1 reservoir in CD4+ regulatory T cells by a droplet digital PCR based approach", VIRUS RES, 16 July 2017 (2017-07-16) *
HEHIR KM等: "Molecular characterization of replication-competent variants of adenovirus vectors and genome modifications to prevent their occurrence", JOURNAL OF VIROLOGY, vol. 70, no. 12, 1 December 1995 (1995-12-01), pages 8461 *
KENNETH CORNETTA等: "Absence of replication-competent lentivirus in the clinic:analysis of infused T cell products", MOLECULAR THERAPY, vol. 26, no. 1, 12 September 2017 (2017-09-12), pages 1 *
QIUCHEN LI等: "A new strategy for the detection of chicken infectious anemia virus contamination in attenuated live vaccine by droplet digital PCR", BIOMED RESEARCH INTERNATIONAL, vol. 2019, 16 May 2019 (2019-05-16), XP093051972, DOI: 10.1155/2019/2750472 *
刘云龙: "基因标志物数字化检测新方法研究", 中国优秀硕士学位论文全文数据库 医药生物科技辑, 15 February 2018 (2018-02-15) *

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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
JP7755490B2 (ja) 2025-10-16
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
IL288404B2 (en) 2025-03-01

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