A simulation-based comparison of centralized and point-of-care supply chain strategies for autologous cell therapy.

Background Aims: The selection between centralized and point-of-care (POC) manufacturing supply-chain network design is a crucial consideration in the autologous cell therapy (AuCT) industry, as each approach offers its advantages and disadvantages.
Methods: This study uses a simulation-based approach to compare and examine the two strategies using the supply chain for chimeric antigen receptor T-cell therapy manufacturing as an exemplar. When does it make sense to use one manufacturing strategy over another? Currently, major manufacturers in the AuCT industry use centralized supply-chain strategies predominantly in practice. The simulation results explain the reasons for this choice. To enhance the competitiveness of the POC strategy, two operation rules are proposed and tested with the simulation. The study uses key performance indicators such as cost, fulfillment time, service level, and resource utilization to provide generic guidelines based on the findings.
Results: The results have revealed that (i) the centralized supply-chain strategy has a significant advantage at current demand levels of a few thousand products per year; (ii) "optimal capacity" exists for the POC strategy that minimizes the cost of goods and (iii) allowing part-time labor and order transshipment can significantly increase the competitiveness of the POC strategy.
Conclusions: This study may be useful in helping commercial manufacturers make informed decisions about their manufacturing approach to enhance their competitiveness in the market and to ensure a high level of patient benefit.
Competing Interests: Declaration of Competing Interest Bruec L. Levine reports personal fees from Akron, Avectas, Immuneel, Immusoft, In8bio, Ori Biotech, Oxford Biomedica, ThermoFisher Pharma Services, UTC Therapeutics, Vycellix and is a co-founder and equity holder in Tmunity Therapeutics (acquired by Kite Pharma) and Capstan Therapeutics, outside the submitted work. Andrew D. Fesnak reports a relationship with Achieve Clinics that is outside the scope of the submitted work. There is no conflict of interest for other co-authors.
(Published by Elsevier Inc.)