Development of anti-AAV assay for detection of pre-existing AAV immunity

Cell & Gene Therapy Insights 2023; 9(5), 719–730


Published: 3 August
Innovator Insight
John Chappell, Zhe Liu

The high natural prevalence of AAV wild-type viruses has resulted in a high frequency of capsid-directed humoral immunity in human populations and many animal models, which may interfere with the effectiveness of AAV-based gene therapies if not identified and managed properly. This case study describes the development of an anti-AAV antibody assay for use in preclinical studies that involve cynomolgus monkeys. This will allow the ability to screen for pre-existing AAV immunity and identify potential low-responding individuals to increase the likelihood of successful transduction and to maximize the utility of the preclinical investigations.