De-risking the final formulation, fill and finish step in cell therapy manufacturing: considerations for an automated solution

Abstract

Final formulation and cryopreservation of the cell product is a critical and high-value step in cell therapy manufacturing. At this stage, the cells have been through a tedious selection, modification and expansion process, and maintaining their health and viability through this step is of utmost importance. This downstream step of final formulation heavily relies on manual processes that bring inherent user-dependent variability, and it becomes unsustain-able with the demand for increased output in a manufacturing setting. The necessity to reduce open process steps, ensure process traceability, minimize DMSO contact time with cells and facilitate electronic data capture establishes the need for flexible automation at this step. The preferred automated system should be functionally closed with single-use disposables and should provide the ability to scale the process in a reproducible fashion. The system should reduce the number of open events compared to the current manual process and ensure material and process data traceability using industry-accepted computation. Implementing automation at this step not only ensures a more consistent product, it may also be an effective way to reduce risk at a critical step to support product delivery to the patients, while also reducing manufacturing costs.