Roundtable Discussion: Residual DNA Guidelines Across Modalities: Unpack Challenges, Risk Assessments, & Regulatory Interactions
- Interpreting current regulatory thresholds (≤10 ng per dose, ≤200 bp fragment size) across gene therapy, vaccines, and monoclonal antibodies
- Practical strategies each field is using to reduce impurities and meet these requirements
- Risk assessment and regulatory dialogue: how companies are engaging with health authorities when thresholds cannot be fully met