CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Process Validation for CAR-T Products: A Continuous Journey" at the PDA/FDA Joint Regulatory Conference, Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

Gayed: Process validation is providing the assurance through collective scientific evidence that the manufacturing process or process in general that is consistently able to deliver a quality product. And for CAR-T, it's unique due to the nature of the individualized treatment for our software.

Gayed: So it's, it's all about the knowledge that we accumulate, these products are relatively new, it's a new modality, so the more knowledge that starts all the way from development, starts from process characterization, and continues through all the process knowledge we learn from the process of validation and continuous rock process validation. So to continue, it said, it's a body of knowledge that we continuously need to keep building to be able to learn more about these products and be able to continuously monitor them and continuously improve our manufacturing processes control strategy. So I would like to see and think of validation is not one time and it's a continuous journey. So the learning is continuous and it's a feedback that will go back and adjust the process controls and process control strategy that we have set up based on modern and additional information.