Method validation and assessment of the biodistribution and shedding for adenovirus vector-based vaccine using qPCR and dPCR

Assessment of the biodistribution and shedding is required for the development of viral vector-based vaccines. Vector copy number is commonly quantified using digital PCR (dPCR) or quantitative PCR (qPCR). However, the regulatory guidelines for bioanalytical PCR assays have not been released at pres...

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Bibliographic Details
Main Authors: Yoichi Tanaka, Sayaka Hamano, Akiko Ishii-Watabe, Yoshiro Saito, Ruri Kikura-Hanajiri
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:Molecular Therapy: Methods & Clinical Development
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Online Access:http://www.sciencedirect.com/science/article/pii/S2329050125001445
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