8:00 am Registration & Morning Refreshments
8:50 am Chair’s Opening Remarks
8:50 am
Successfully Scaling-up the Transfection Process for Viral Gene Therapies
9:00 am Gene Therapy Manufacturing Challenges & Scale-Up
Synopsis
- 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
Synopsis
- 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
Synopsis
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
Synopsis
- 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