Vector Characterization & Validation


Professor R. Jude Samulski, University of North Carolina at Chapel Hil

The landmark approval of Spark Therapeutics’ Luxturna changed the landscape of gene therapy forever and brought many lingering and emerging issues into sharp relief – not least, the need for viral and non-viral vector manufacturing to advance to a stage where it is genuinely fit for commercial purpose. As the current capacity crunch intensifies, the onus is on efficiency in product development and manufacture as never before.

  • Advances in gene therapy characterization and QC
  • Keys to successfully validating vector bioprocesses
  • Latest regulatory guidance