Genotoxicity, vectors, and the power of integration site analysis

In this episode, Michael Stump and Matteo Franco from ProtaGene explore the growing importance of integration site analysis (ISA) in cell and gene therapy. As viral vectors like lentivirus and AAV become more widely used, understanding where and how they integrate into the genome is essential for assessing genotoxicity and long-term safety. The discussion dives into how sequencing reveals integration locations, clonal expansion risks, and potential activation of oncogenes. They also highlight how tools like digital PCR complement sequencing as orthogonal methods that help enable precise quantification, validation, and new applications like vector integrity and copy number analysis. Beyond the science, the conversation explores the CRO role in supporting both early-phase discovery and late-stage regulatory needs, balancing innovation with regulatory expectations, and adapting to emerging modalities like LNPs. The career corner brings a mix of honesty and humor, from chaotic CRO workdays to broken PCR capillaries and runaway lab mice, paired with thoughtful advice on navigating industry paths, building GMP expertise, and finding the right fit between academia and industry. Visit the Absolute Gene-ius page to learn more about the guests, the hosts, and the science we explore. Discover the Applied Biosystems QuantStudio Digital and Real-Time PCR Systems powering real-world research across neuroscience, oncology, agriculture, and more.