Detecting Pre-Existing Antibodies to AAV Gene Therapies

Time: 11:00 am
day: Pre-Conference Day


One of the inherent challenges to effective AAV gene therapy treatment is the prior exposure and neutralizing antibody (NAb) generation in a large number of target populations. The methods used for testing for seropositivity prior to transfer remains a hotly-debated topic, with no universal test or titer currently deployed as an industry standard for detecting anti-AAV antibodies in patients. Whilst this remains the case, having a robust understanding of the NAb vs TAb (Total Antibody) debate – including the practical considerations and rationale behind choosing either/or – is crucial.

Attend this workshop to learn about:

  • Outlining the main differences total antibody (TAb) and transduction inhibition (TI) assays
  • Practical considerations for choosing between the TAb and TI assays
  • Key factors for determining cut-off values
  • Requirements when developing a diagnostic assay for AAV antibody assessments
  • Regulatory insights and planning for diagnostic assay submissions