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


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, 2seventy bio
  • 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