Chief Scientific Officer Sword Bio Hebron, New Hampshire
This presentation with discuss pre-existing immunogenicity against AAV gene therapies and the bioanalytical challenges associated with these assays. Building these assays follows a fairly standard practice and the guidelines used for developing anti-drug antibodies (ADA) for the purpose of testing in study samples in both non-clinical and clinical programs. However, since such a large proportion of individual samples begin with pre-existing antibodies there are challenges to the validation of these assays that must be considered in both development and validation. Increased number of individuals to screen for building negative control pools and setting cutpoints, altered testing paradigms unlike the typical 3-tiered testing for ADA assays, and challenges with reagent availability all require different approaches as compared to more common biotherapeutics.
Learning Objectives:
...will be able to develop an ADA testing strategy for gene therapy programs.
...will be prepared for obtaining and/or creating critical reagents for anti-AAV ADA assays
...will be aware of current industry expectations for measuring anti-AAV antibodies in non-clinical and clinical programs
