Replication-Competent Virus Testing: A Critical Step In Cell And Gene Therapy Quality Control

By Marwan Alsarraj

Scientists commonly use lentiviruses and adeno-associated viruses (AAVs) as viral vectors in cell and gene therapy (CGT) production. However, therapies that use these viruses must undergo strict quality control measures, including testing for replication-competent viruses (RCV), to ensure that the treatment is safe. Cell culture–based methods are currently the gold standard for RCV testing, but it can take up to 45 days for results to be returned. Droplet Digital™ PCR (ddPCR™) kits now offer an attractive orthogonal method as they are highly sensitive and return results in just eight hours. These kits can potentially accelerate the development of a new wave of CGTs.