Confronting the Challenges of Viral Vector Genome Integrity for Consistent Gene Therapy Outcomes
Time: 4:30 pm
day: Day One
Details:
- Understanding accurate detection of viral vector genome integrity is crucial to ensure the vector carries the correct genetic material without mutations, deletions, or rearrangements that could impact therapeutic efficacy or safety
- Address how variability in the efficiency of viral packaging and transduction processes can lead to inconsistencies in genome integrity, requiring robust methods to quantify and control this variation across different production lots and stages
- Ensuring viral vector genome integrity involves complying with stringent regulatory standards, necessitating the development of validated, reproducible assays to guarantee that the gene therapy product consistently meets quality and safety requirements throughout its lifecycle
