Interlaboratory assessment of candidate reference materials for lentiviral vector copy number and integration site measurements

Interlaboratory assessment of candidate reference materials for lentiviral vector copy number and integration site measurements

While lentiviral vectors have played a critical role in the emergence of gene-modified cell therapies, safety concerns remain regarding potential insertional mutagenesis. Regulatory authorities strongly recommend risk assessment and management of vector copy numbers (VCNs), integration profiles, and...

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Main Authors: Hua-Jun He, Zhiyong He, Steven P. Lund, Laure Turner, Yongjun Fan, Yu Qiu, David C. Corney, Boro Dropulic, Rimas Orentas, Oxana Slessareva, Priscilla Welch, Katie Dungca, Ellen Stelloo, Gabrielle Dijksteel, Harma Feitsma, Sana Ahmed-Seghir, Rostyslav Makarenko, Engin Altunlu, Daniëlle Steenmans, Jan Spanholtz, Monica Raimo, Shai Senderovich, Barbara S. Paugh, Chieh-Yuan Li, Benjamin Schroeder, Alexandra S. Whale, Dilek Yener, Carole A. Foy, Shareef Nahas, Feng Tu, Michael Sheldon, Yan Ding, Jennifer Kandell, Uma Lakshmipathy, Jennifer H. McDaniel, Justin M. Zook, Sierra Miller, Samantha Maragh, Simona Patange, Mahir Mohiuddin, Alessandro Tona, Kenneth D. Cole, Sheng Lin-Gibson
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Molecular Therapy: Methods & Clinical Development
Subjects:
lentiviral vector, LV
vector copy number, VCN
integration site analysis
next generation sequencing
NGS
reference material
Online Access:http://www.sciencedirect.com/science/article/pii/S2329050125000671
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