Quantification Of Vector Genomic DNA And Residual DNA In Gene Therapy Vectors Using ddPCR

By Sushma A. Ogram, Small Scale and Assay Development and Analytics, Head, Thermo Fisher Scientific

Capitalizing on advances in science and technology to help cure cancer and genetic diseases has led to significant growth of the cell and gene therapy (CGT) market. With so many CGT products in the pipeline today, as well as high success rates for those in clinical trials, the FDA anticipates it will be approving 10 to 20 CGT products a year by 2025.¹ A key component of bringing these life-saving drugs to market is the production of viral vectors that are used to deliver the therapeutic gene. However, this requires efficient and scalable manufacturing strategies, which currently stands as one of the biggest barriers for commercialization of CGT products. One area where there is a significant need for improvement in this field is analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.