Pioneering quality control in biomanufacturing of cell and gene therapies
The BioInsights Podcast
Chapters
1:27
1. Can you tell us a bit briefly about your background and what you are currently working on?
4:38
2. How do you establish in-process controls and release specifications for specific intermediate cell banks, drug substances, and final drug products?
10:24
3. Looking at in-process QC testing, why is this important for the development of cell banks such as iPSCs and final cell therapy products?
13:31
4. Can you explain the distinction between method qualification and method validation in the context of cell-based therapies and how does each contribute to ensuring product safety and efficacy?
17:43
5. What role does risk management play in the overall QC strategy for cell-based therapies and how are these integrated into the decision-making process?
24:39
6. Do you currently employ or plan to implement automated QC testing methods in your processes. If so, what advantages do you anticipate that these methods will bring to your QC strategy?
The BioInsights Podcast
Pioneering quality control in biomanufacturing of cell and gene therapies
Dec 05, 2024
Season 3
Episode 10
BioInsights
Lauren Coyle, Commissioning Editor, speaks with Dhruv Sareen, Executive Director at Cedars-Sinai Biomanufacturing Center, and Johnathan Rodriguez, Quality Control Manager at Cedars-Sinai Biomanufacturing Center, about the roles of in-process controls, method validation, risk management, and automation in biomanufacturing. They will highlight strategies to ensure product safety, consistency, and regulatory compliance for cell and gene therapy products.
