Following a short presentation, participants will take part in a guided roundtable discussion to share perspectives on defining acceptable impurity limits, aligning analytical methods across sites, and ensuring compliance amid shifting standards. This interactive format aims to foster collaborative learning and actionable takeaways that link analytics, safety, and CMC strategy.

• Linking analytics to safety: Examine how advanced quantification methods (dPCR + NGS) deliver deeper insight into impurity identity, size, and packaging- and what this means for dose safety and consistency
• Understanding regulatory misalignment: Discuss where current impurity thresholds and definitions inherited from biologics or vaccine frameworks fail to align with gene therapy products
• Upstream implications: Identify how analytical findings can inform plasmid design, ratio optimization, cell substrate, and nuclease strategies to proactively reduce impurity burden