Innovations in Partial Capsid Characterisation: From Tools & Techniques to Regulatory Perspectives
Time: 9:05 am
day: Pre-Conference Workshop Day
Details:
Characterising partial capsids in gene therapy is becoming increasingly crucial for optimising product quality and overcoming regulatory concerns. Understanding exact capsid content aids in fine-tuning process development, ensuring efficient gene delivery, minimising immunogenicity, and altogether advancing safer, more effective gene therapies.
This workshop will set out to include:
- Comparing traditional and novel techniques for partial capsid extended characterisation
- Discussing methods for quantifying the severity of partial capsids and streamlining the response to analytic readouts • Characterising batch-batch partial capsid comparability
- Determining methodologies for appropriate reference standard production and discussing mechanisms to enhance lab to lab reproducibility
- Developing robust and universal safety thresholds for partial capsid percentages
- Understanding regulatory perspectives on partial capsid characterisations
