Automation Focus Day: Friday, September 26

8:50 am Chair’s Opening Remarks

Evaluating the Basics & Need of Automation to Gain a Clear Picture & Implement It in Your Manufacturing Process

9:00 am Reviewing the Process of Automation Implementation to Understand the Basic Steps Required

  • Elisaveta Todorova Associate Director, Process Development & Technology Innovation, TScan Therapeutics

Synopsis

  • Discussing the critical steps of cell therapy like cell isolation and expansion that will benefit from quality control
  • Examining the hurdles associated with automation implementation
  • Emphasizing the need to control the entire process to meet regulatory guidelines

9:30 am Taking the Man Out of Manufacturing: Automation as a Critical Strategy to Enable Decentralized CGT Production

  • Ian Gaudet Head of US Technical Operations, Vice President, Galapagos

Synopsis

  • Decentralized manufacturing holds promise to improve patient access autologous cell therapies
  • Complexity in a decentralized manufacturing network poses a hurdle to at-scale commercial production
  • Automation of process, analytics and information management is essential to enable a successful decentralized CGT delivery paradigm

10:00 am Smart Automation: The Next Cell Therapy Revolution

  • Raymond Luke Senior Director, MS&T & Head of CMC, Verismo Therapeutics

Synopsis

  • Review of the current state of automation in autologous cell therapy
  • Overview of the upcoming innovations in automation including process-in-a-box and robotic automation technologies
  • Looking forward to the next revolution in cell therapy manufacturing: smart automation

10:30 am Morning Networking Break

Delving into the Specifics of Automation to Make the Transition Smooth, Cost Saving & Quick

11:00 am Exploring What Tools & Techniques are Required for Automation to Make it a One- Stop-Shop Solution & Quicken Manufacturing Timelines

  • Tuhin Bhowmik Associate Director, Process Engineering & MST, Arcellx

Synopsis

  • Identifying the equipment required for automation such as automated bioreactors and digital monitoring tools
  • Harnessing automated equipment to manufacturing a one-stop-shop process
  • Utilizing automated process to reduce manufacturing timelines

11:30 am Reviewing If You Need to Automate All Stages of Manufacturing or Only Some to Maximize Efficiency & Save Costs

  • Bassem Gayed Senior Director, Technical Process Engineering, CAR-T MS&T, Bristol Myers Squibb

Synopsis

  • Exploring how to automate difference stages of manufacturing
  • Identifying the need of automation in all stages
  • Revaluating the implantation of automation across the manufacturing process

12:00 pm Networking Lunch

Reviewing the Pros & Cons of Automation to Gain a Holistic Overview Before Making Your Decision

1:00 pm Advancing CAR-T Manufacturing with Automation

  • Yan Li Senior Director, Process Development, Cabaletta Bio

Synopsis

  • Supply challenges for autologous CAR-T cell manufacturing
  • Discuss the pros and cons for automation
  • Case study of CAR-T manufacturing using automation (Cell Shuttle)

1:30 pm Debating the Need for Automating Manufacturing Processes to Ensure You’re Doing the Right Thing

Synopsis

  • Weighing the efficiency of automation vs the cost
  • Evaluating how automation can improve product quality
  • Examining the potential effect automation can have on consistency in manufacturing

2:00 pm Reviewing the Drawbacks & Challenges Associated with Automated Manufacturing to Gain a Holistic Overview

  • Yana Wang Senior Director, Cell Therapy Oncology, Takeda

Synopsis

  • Exploring the challenges that occur when transitioning to automated manufacturing
  • Overcoming the challenges of implementing automation into existing processes
  • Identifying the extra maintenance needed for automated manufacturing

2:30 pm Afternoon Networking Break

Exploring the Applications of Automation in Quality Control & Personalized Manufacturing to Ensure Product Quality & Success

3:00 pm Roundtable Discussion: Analyzing How to Introduce Automation into Quality Control & How it Can Maximize Product Quality

Synopsis

  • Examining how to apply automation to quality control, what are the challenges?
  • Reviewing the effect an automated process has on improving product quality
  • Understanding what aspects of quality control can be automated

4:00 pm Chair’s Closing Remarks

4:05 pm End of 10th CAR-TCR Summit