Inventory Replenishment and Transshipment for Distributed Autologous Cell Therapy Manufacturing Networks.

Autologous cell therapy (AuCT) manufacturing networks must balance two competing objectives: reducing cost and improving patient access to time-sensitive therapy. This study compares three AuCT manufacturing network designs: a centralized network with a single manufacturing facility, a coordinated point-of-care (POC) network in which POCs can coordinate and transship specimens and consumables when needed, and an independent POC network in which each POC operates separately. Minimizing the time from specimen harvest to therapy infusion is used as an operational proxy for patient benefit. The analysis considers reagent replenishment, specimen and reagent transshipment, patient deterioration while waiting for therapy manufacturing to begin or during the therapy manufacturing process, and bioreactor capacity planning under a high patient service-level requirement. Using data based on a commercial-style AuCT network with one manufacturing site, 20 geographically distributed POCs, and two consumable suppliers, the results show that the coordinated POC network can achieve total cost close to that of the centralized network while maintaining turnaround time close to that of the independent POC network. These findings provide decision-support insight for commercialization and industrialization of AuCT manufacturing by quantifying when coordinated distributed manufacturing may offer a practical compromise between the economic efficiency of centralized production and the responsiveness of local manufacturing.