Gene therapies and cellular therapies use viral vectors as vehicles to deliver gene of interest. There is an immunogenicity risk associated with such vectors as they activate the innate phase (pattern recognition receptors, complement system etc.) and prime and activate the adaptive phase response (mediated by T cells). Based on the nature of transgene and tropism of vector serotype, the risk-based bioanalytical would need to adapt to decide whether humoral or cellular immune response would be needed.