Viral Vector Production: How CDMOs Influence Late-Stage Development Success

Viral cell and gene therapies (CGT) have transformed modern medicine by offering durable, and in some instances curable, solutions for rare and previously untreatable diseases. Although only 24 viral vector–based gene therapies have been approved to date, hundreds more are advancing through clinical pipelines. Their promise is significant, but so are the risks for CGT manufacturers. Complex biology, high-dose–related fatalities, and manufacturing variability have prompted heightened regulatory scrutiny, leaving developers with an exceptionally narrow margin for error. This is especially true at the late stage of viral vector-based gene therapy.