Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

Immunogenicity has imposed a challenge to efficacy and safety evaluation of adeno-associated virus (AAV) vector-based gene therapies. Mild to severe adverse events observed in clinical development have been implicated with host immune responses against AAV gene therapies, resulting in comprehensive...

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Bibliographic Details
Main Authors: Tong-yuan Yang, Manuela Braun, Wibke Lembke, Fraser McBlane, John Kamerud, Stephen DeWall, Edit Tarcsa, Xiaodong Fang, Lena Hofer, Uma Kavita, Vijay V. Upreti, Swati Gupta, LiNa Loo, Alison J. Johnson, Rakesh Kantilal Chandode, Kay-Gunnar Stubenrauch, Maya Vinzing, Cindy Q. Xia, Vibha Jawa
Format: Article
Language:English
Published: Elsevier 2022-09-01
Series:Molecular Therapy: Methods & Clinical Development
Subjects:
adeno-associated virus
gene therapy
immunogenicity
risk assessment
clinical mitigation
bioanalytical methodologies and validation strategies
Online Access:http://www.sciencedirect.com/science/article/pii/S2329050122001103

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http://www.sciencedirect.com/science/article/pii/S2329050122001103

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