Viral vector

A virus engineered to deliver a therapeutic gene into cells, with the genes it needs to replicate removed. Adeno-associated virus (AAV) and lentiviral vectors are the most common, used in gene therapy and to modify cells such as CAR-T cells. Key quality attributes include genome and infectious titer, the ratio of full to empty capsids and testing for replication-competent virus. In Japan, clinical use of a viral vector, as a living modified organism, needs procedures under the Cartagena Act in addition to those under the PMD Act.