Cell Therapy Manufacturing: A Look Under the Hood - Learning from Outside the Industry. Can We Make CAR-T Cells Like We Make Cars?

Presentations and Panel Discussions Will Cover The Following:

1. Overview of Current CAR-T Cell Manufacturing Processes: A brief introduction to the current state of CAR-T cell production, highlighting the fact that the root cause of all complexities, challenges, and limitations in the existing methods is a lack of standardized sterile liquid handling steps.

2. Lessons from Automotive and Other Manufacturing: An in-depth analysis of manufacturing principles from various other industries, such as lean manufacturing, just-in-time production, and quality control, and how these can be adapted to cell therapy manufacturing to enable standardized and simplified sterile liquid handling thereby unleashing the potential for high-throughput manufacturing.

3. Case Studies of Cross-Industry Innovations: Presentation of case studies where techniques from other industries have successfully been integrated into CAR-T cell manufacturing (Ignacio to describe what he did for Kymriah), offering insights into how G-Rex based CAR-T manufacturing further exacerbates the benefits of applying techniques from other industries for an efficient high throughput CAR-T cell manufacturing model (Ignacio to describe what would have been possible if Kymriah used G-Rex)

4. Technological Advances and Automation in Manufacturing: Exploration of the latest technological advances, including automation and robotics, that could be leveraged to enhance efficiency, scalability, and reproducibility in CAR-T cell manufacturing without requiring end to end automation. (Discuss our partnership with Cellular Origins and how automating unit operations so that they are highly repeatable and more like a standard production fixture used in other industries (i.e., a drill press, a pneumatic press, other standard production fixtures) creates flexibility, repeatability, and high throughput at low cost. It does not require end to end automation and in fact it is a far more economical and future proof model.

5. Regulatory Myth vs Fact: Discuss both the regulatory and current therapeutic quality team challenges in cell therapy, ensuring safety, efficacy, and compliance.  What can be done to enhance and ensure compliance with FDA standards while maintaining the flexibility to make necessary changes to increase throughput and efficiency.

Audience Learnings:

Comprehensive Insight into CAR-T Cell Production: Participants can expect to gain a nuanced understanding of the intricacies involved in CAR-T cell manufacturing, including the technological and procedural complexities, and the obstacles that currently impede streamlined production.

Integration of Broader Manufacturing Principles: Audience members will learn how principles from other manufacturing sectors, such as the automotive industry's lean manufacturing, can be applied to the production of CAR-T cells to improve efficiency and product consistency and why G-Rex is a perfect manufacturing device to enhance this model.

Recognition of Successful Cross-Industry Applications: Attendees will be exposed to real-world examples where cross-industry innovations have been adopted in the CAR-T cell manufacturing biomedical field. They will learn about the potential for such crossover techniques to be utilized in CAR-T cell production, fostering a mindset open to interdisciplinary solutions.

Understanding Regulatory Compliance in Innovation: The presentation will provide attendees with a clear distinction between the myths and facts of regulatory compliance when implementing new manufacturing practices in cell therapy. They will learn strategies for ensuring safety, efficacy, and adherence to FDA standards while embracing new methods for increased throughput, capacity, and efficiency.