908 Devices: Improving Cell and Gene Therapy Manufacturing Processes by Automated On-Line and In-Line Bioprocess Analytical Technologies
Wednesday, May 29, 2024 07:00 AM - 08:00 AM
Room 211
Corporate Session
Chair
Speakers
Despite groundbreaking advancements in cell and gene therapies, the translation from the laboratory to clinical applications demands the establishment of robust and scalable manufacturing processes. A pivotal aspect of this translation in cell therapies is ensuring consistent and scalable cell expansion to prevent deviations in product quality.
In the realm of gene therapies, the pursuit of scalable processes is imperative for enhancing and sustaining high viral vector productivity. As the demand for cell and gene therapies continues to grow, developing methods that are not only efficient but also capable of accommodating larger production volumes becomes paramount. These challenges necessitate real-time monitoring of Critical Process Parameters (CPPs) that impact cell growth and health. The real-time monitoring of these CPPs provides invaluable insights into the metabolic state of cell cultures, facilitating prompt adjustments to optimize production processes and enhance manufacturing robustness.
This presentation by 908 Devices and Terumo Blood and Cell Technologies delves into pioneering strategies designed to address the challenges associated with cell and gene therapy manufacturing.
Session Objectives
• Integration of a hollow fiber perfusion bioreactor for cell expansion with automated, on-line solution for continuous CPP monitoring and process optimization
• Introduction of a Raman-based analytical solution that streamlines the monitoring of critical process parameters, offering a dynamic and automated control mechanism without the complexities of traditional chemometric modeling.
- Milla Neffling, PhD, Senior Manager, Bioprocess Applications, 908 Devices, United States
Speakers
- Nick Randall, Bioprocessing Product Manager, 908 Devices, United States
- Mindy Miller, PhD, Mgr Sr. Scientist, Research and Development, Terumo Blood and Cell Technologies, United States
Despite groundbreaking advancements in cell and gene therapies, the translation from the laboratory to clinical applications demands the establishment of robust and scalable manufacturing processes. A pivotal aspect of this translation in cell therapies is ensuring consistent and scalable cell expansion to prevent deviations in product quality.
In the realm of gene therapies, the pursuit of scalable processes is imperative for enhancing and sustaining high viral vector productivity. As the demand for cell and gene therapies continues to grow, developing methods that are not only efficient but also capable of accommodating larger production volumes becomes paramount. These challenges necessitate real-time monitoring of Critical Process Parameters (CPPs) that impact cell growth and health. The real-time monitoring of these CPPs provides invaluable insights into the metabolic state of cell cultures, facilitating prompt adjustments to optimize production processes and enhance manufacturing robustness.
This presentation by 908 Devices and Terumo Blood and Cell Technologies delves into pioneering strategies designed to address the challenges associated with cell and gene therapy manufacturing.
Session Objectives
• Integration of a hollow fiber perfusion bioreactor for cell expansion with automated, on-line solution for continuous CPP monitoring and process optimization
• Introduction of a Raman-based analytical solution that streamlines the monitoring of critical process parameters, offering a dynamic and automated control mechanism without the complexities of traditional chemometric modeling.
SPONSORED BY:
