8:00 am Registration & Morning Refreshments

8:50 am Chair’s Opening Remarks

  • Kristin Luther Associate Director - Downstream Process Development, Vesigen Therapeutics

8:50 am
Successfully Scaling-up the Transfection Process for Viral Gene Therapies

9:00 am Gene Therapy Manufacturing Challenges & Scale-Up

  • Jun Li Associate Director - Upstream Process Development, Gene Therapy, Ultragenyx


  • Reviewing the Pinnacle PCL Platform 2000L batch process
  • Deep-dive into the challenges in manufacturing & possible solutions
  • Overcoming the impacts & effects of scale-up

9:30 am Session Reserved for Mirus Bio More details to follow

10:00 am A Case Study in Commercial Site Build with Process Scale-Up Execution

  • Brad Mickey Executive Director, Manufacturing and Operations Site Head, Astellas Gene Therapies


  • Discussing benefits associated with owning/building a site for future production
  • Exploring the challenges associated with scale-up & process transfer
  • Examining case study results & associated optimization techniques

10:30 am Morning Refreshments & Speed Networking


A session dedicated to taking advantage of face-to-face networking time. This an exciting opportunity to get an understanding of who else is overcoming similar challenges within the gene therapy process development space.

11:00 am
Ensuring High Quality Transgene Packing Through Selecting the Optimal Plasmid Ratio

11:30 am Achieving Optimal Complex Size Regardless of Operation Scale for Transient Transfection


  • Exploring the impact of transfection complex size on productivity & product quality in gene therapy manufacturing
  • Implementing scale-independent transfection through strategic control of complex assembly
  • Enhancing process robustness through automation and process analytical tools

12:00 pm Session Reserved for Culture Biosciences

  • Jean-Marc Guedon Senior Scientist, Viral Vector Process Development, Culture Biosciences