bioMérieux Presentation: Smart Quality Testing for Unique Cell and Gene Therapy Challenges
Friday, May 31, 2024 10:15 AM - 10:30 AM
Exhibit Hall - Theatre B
Global Showcase Presentation
Presenter(s)
• Patrick Daoust, Chief Business Officer, CATTI, CANADA
• Félix A. Montero Julian, PhD, Senior Scientific Director, bioMérieux, FRANCE
Developing cell and gene therapies presents many challenges. Low-production volume, short shelf life, temperature sensitivity, complex raw materials, tracking and data integrity, scalability, and patient demands must all be taken into consideration. Smart Quality Control provides manufacturers with the ability to adjust critical heating parameters in real-time and optimizes heating requirements of production. In doing so, this approach enables the maximization of product yield. Adding rapid and easy-to-use technologies to the operations brings overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to ensure patient safety.
Session Objectives
• New regulations have been written specifically to support the use of rapid analytical methods for the quality control of products with short shelf lives such as advanced cell therapies.
• Simple workflows with little hands-on time reduce the need for extensive expertise and training to get an objective, rapid, and accurate result. This allows decentralization of lab testing and moves it closer to the manufacturing suite.
• Patrick Daoust, Chief Business Officer, CATTI, CANADA
• Félix A. Montero Julian, PhD, Senior Scientific Director, bioMérieux, FRANCE
Developing cell and gene therapies presents many challenges. Low-production volume, short shelf life, temperature sensitivity, complex raw materials, tracking and data integrity, scalability, and patient demands must all be taken into consideration. Smart Quality Control provides manufacturers with the ability to adjust critical heating parameters in real-time and optimizes heating requirements of production. In doing so, this approach enables the maximization of product yield. Adding rapid and easy-to-use technologies to the operations brings overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to ensure patient safety.
Session Objectives
• New regulations have been written specifically to support the use of rapid analytical methods for the quality control of products with short shelf lives such as advanced cell therapies.
• Simple workflows with little hands-on time reduce the need for extensive expertise and training to get an objective, rapid, and accurate result. This allows decentralization of lab testing and moves it closer to the manufacturing suite.
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