Case Study: Scaling Up Allogeneic Therapies to Move Towards Industrial-Scale Production and Defining a ‘Batch’ for Off-the-Shelf Products

Time: 3:45 pm
day: Day One


• Establishing the fundamental characteristics of an allogeneic platform
• Developing flexibility in processes to enable scalability through phases in line with market need
• Formulating and freezing large batches, defining a ‘batch’ for allo therapies, and communicating this with regulators
• Managing scalability with a limited donor pool of minority cell populations, and demonstrating product safety and efficacy at scale