CAR T Cell Formulation Process With Intermittent Mixing

The patent divides the drug product process into distinct stages with specific timing controls. The formulation step is separated from the filling step, and intermediate mixing operations are scheduled at specific intervals. This segmentation allows the process to handle large batches while maintaining cell health through controlled exposure to stress conditions at different process stages.

The patent performs preliminary formulation of cells in a composition containing cryopreservative before filling into containers. This preliminary action allows cells to be prepared and stabilized in advance, reducing the time they are exposed to stress conditions during the overall process. The formulation step is completed before filling, allowing for optimized cell preparation without extending the total process time.

The patent implements periodic mixing instead of continuous mixing. Mixing operations are performed at specific intervals (e.g., after formulation, before filling) rather than continuously throughout the entire process. This periodic action maintains dosage homogeneity when needed while minimizing mechanical stress on cells during non-mixing periods, thereby improving cell viability.

The patent dynamically adjusts mixing parameters based on process requirements. The mixing intensity and duration are optimized for each specific step (formulation, filling) rather than applied uniformly throughout. This dynamic approach allows strong mixing when homogeneity is critical and reduced mixing when cell protection is prioritized, balancing manufacturing precision with cell viability.