Innovations in Partial Capsid Characterisation: From Tools & Techniques to Regulatory Perspectives

Time: 9:05 am
day: Pre-Conference Workshop Day


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