A method to validate viral copy-number assay involving a hybrid amplicon and duplex droplet digital PCR

Viral copy-number (VCN) assay is a powerful, effective method to quantify toxicity, cellular kinetics, and durability of virus-modified cell therapy products. The qualification and validation of assay requires reference control. Traditionally, plasmids and cell lines are used as reference controls,...

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Bibliographic Details
Main Authors: Raymond Wu, Frank Luh, Soo-Mi Kweon, Yun Yen
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Molecular Therapy: Methods & Clinical Development
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Online Access:http://www.sciencedirect.com/science/article/pii/S2329050125000786
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