iPSC Therapy & Manufacturing: Scaling, Automation, and Global Access

Geoffrey Stephens, PhD
Founder & CEO, AiCella

Talk title: Revolutionizing Cell Therapy Manufacturing With AI: Precision, Efficiency, And Beyond

Introduction:

The complexity of CAR T manufacturing sets it apart from other treatment modalities, and despite significant progress in the field of CAR T manufacturing, there is still much we don't fully grasp about the complex processes involved in creating these therapies. As many as 30% to 60% of patients fail to respond to CAR T therapies, and between 30-40% of patient manufacturing runs fail to yield sufficient cells for treatment. We hypothesize that AI-based approaches have the potential to provide significantly deeper insights into the influence of the manufacturing process on cell performance in patients. To address the challenge of predicting the performance of cell therapy products in patients, we utilized our AI/ML platform, Insights™, which leverages the power of artificial intelligence and machine learning to optimize and automate various aspects of biomanufacturing. The InsightsTM platform that leverages 27 commonly used ML/DL-based algorithms to develop bespoke models for CAR T therapy. By uncovering important clues into the key process parameters involved in the manufacturing of these therapies, we elucidate how the process of manufacturing impacts patient responses to therapy.

Xian Weng Jiang, PhD
Director of Product Solutions, Mytos

Talk title: Flask-Based Automation Platform to Unlock Scalable Manufacturing of Regenerative Medicine

Introduction:

Regenerative medicines show extraordinary potential, but their impact is limited by manual, labour-intensive manufacturing processes that are costly, variable, and hard to scale. To address this, Mytos has developed a flask-based automation platform that combines precise environmental control, fluid handling, and integrated monitoring while maintaining compatibility with standard adherent cell culture formats.
This approach allows therapy developers to transition from manual to automated manufacturing with minimal process redevelopment. The platform supports consistent, closed, and traceable operation suitable for GMP environments, enabling robust expansion of stem cells and differentiation to other therapeutic cell types.
By automating without breaking the science, Mytos provides a simple yet scalable foundation for industrialising regenerative medicine manufacturing — reducing variability, improving reproducibility, and lowering cost per dose. iDEM technology represents a key step toward making advanced therapies scalable, reliable, and globally accessible.