This will be half an hour talk and will be geared towards the following discussion:
1.Considerations of Immunogenicity Risk during Discovery and Development of rAAV Therapies. 2. Knowing the strategies/characteristics that we typically use to assess immunogenicity risk from critical attributes. 3. A discussion on the vivo and/or in vitro assays/models for assessing attribute immunogenicity risk. 4.Current opinion on how we are using data from in vitro models to assess/justify immunogenicity risk of attribute levels and in carving a mitigation strategy.
Learning Objectives:
Upon completion of this symposium participants will be able to demonstrate the strategies/characteristics to assess immunogenicity risk for the critical quality attributes.
Upon completion of this symposium participants will be able to demonstrate the application of in vitro/in vivo models to support justification of specifications for the attribute levels.
Upon completion of this symposium participants will be able to know how we are using data from in vitro models to assess/justify immunogenicity risk of attribute levels and in carving a mitigation strategy.
