Pre-Conference Workshop Day: Tuesday, June 11, 2024

8:00 am Check In & Coffee

9:00 am Workshop A: Automation

Achieving End-to-End Automation: Moving Towards Increasingly Automated & Closed Manufacturing Processes

  • Paul Kopesky Vice President - Process Development, Beam Therapeutics
  • Seth Andrews Process Engineer/Supervisor, Imugene


As more cell therapies advance through clinical trials towards potential approval, manufacturers are looking to automated strategies and standardized systems for increasing capacity to meet demand. Automated, closed-manufacturing promises to significantly reduce manual intervention and human errors, support robust process performance, improve product quality, speed product delivery, and reduce costs.

Join to:

  • Discuss advances and unmet needs in automation, from manufacturing to quality systems and analytical sciences
  • Understand the extent of automation required – end-to-end or units – and degree of unit operation integration
  • Contrast tradeoffs of bringing automation in-house vs. outsourcing to vendor technologies

12:00 pm Lunch Break & Networking

1:00 pm Workshop B: Comparability

Exploring Best Practices for Demonstrating Product & Process Comparability

  • Yan Wang Director & Head of Cellular Process Development, Regeneron
  • Elizabeth Huang Senior Scientist, Process Development, Arsenal Bio


During the clinical development of a cell-based therapy product, changes are often necessary to the manufacturing process to improve the performance and quality of the final product. However, to successfully implement a process change, we must demonstrate the comparability of the pre- and post-process, and the final product.

Join to:

  • Discuss changes that commonly occur to the process, facilities, raw materials, and analytical methods
  • Understand key elements of an effective comparability study (1) the level of risk by type of process change, (2) stepwise reduction of residual risk, and (3) a risk-based effort by stage of clinical development
  • Explore best practices for effective demonstration of comparability 

4:00 pm End of Workshop Day