The journey of the patient from vein-to-vein is a complex process that requires a multitude of products, instrumentation, equipment and regulatory compliant infrastructure. The CAR T cell therapy journey beings with harvesting blood from a sick patient, isolating and activating the appropriate T cell population, and then modifying these cells to express a chimeric antigen receptor.
When the cell engineering and processing is complete, a rigorous characterization and quality control process begins to ensure patient safety and efficacy. This expansive process requires a sample tracking system mechanism for traceability and logistical infrastructure to maintain functional integrity of the living drug product. The final step in the process is delivery of this most valuable product directly to the patient.
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