The viral contamination risk of cell and gene therapy products is significant. Multiple factors open the windows for viruses to enter the process. The current viral risk mitigation strategies have limitations and can either not be applied or have limitations to cover a broader range of potential viral contaminants. One of the most important entry points to monitor are the cells. They are used to produce critical components like gene vectors or are the product itself. Next-generation sequencing is a tool with the broadest breadth of pathogen detection while maintaining high sensitivity. It should become a mandatory tool in the characterization of cells to minimize the safety risk but also the business risk, which can be fundamental if a virus contamination occurs at a late stage.
Key takeaways from this session include
- cell substrate viral contamination risk
- testing tools and their limitations
- NGS for viral safety testing
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