Advancements in Residual DNA Detection & Quantification Methods in Gene Therapy
Time: 9:00 am - 12:00 pm
day: Pre-Conference Day, Workshop B
Details:
• Discuss the relative advantages and disadvantages of specialized host cell specific DNA kits for residual DNA detection
• Examine the growing adoption of digital PCR for residual DNA testing and its benefits over traditional qPCR methods in overcoming the need for standard curves
• Analyze the implications of FDA regulations regarding a 200-base pair limit on fragment length in residual DNA analysis
• Discuss the advantages and disadvantages of long and short-read sequencing methods to provide qualitative insight alongside quantitative assessments of host cell DNA presence
• Explore strategies for ensuring compliance with evolving regulatory standards while optimizing detection sensitivity and accuracy
