Cost analysis of vein-to-vein CAR T-cell therapy: automated manufacturing and supply chain

Cell & Gene Therapy Insights 2020; 6(3), 487–510

10.18609/cgti.2020.058

Published: 2 June 2020
Research Article
Adriana Lopes , Rob Noel, Andrew Sinclair

A cost model was described using Biosolve to measure the impact of automation and scale-out of a CAR-T manufacturing process, and associated supply chain. The partially automated CAR-T manufacturing process was the most economical configuration by CoGs analysis. However, after scale-out and inclusion of the impact of time by NPC evaluation, the manual CAR-T process became the most cost-effective option to meet an annual demand of 5,000 patients. Key process cost drivers were identified as the viral vector required to introduce CARs into T-cells and QC tests. A sensitivity analysis was undertaken to aid a manufacturer on whether to produce or undertake the latter in-house or outsource. Local and centralized CAR-T supply chain models to treat a peak demand of 5,000 patients were also compared. The cost of treatment to the patient, including supply chain costs, was estimated to be between $78k–$93k. A sensitivity analysis of the supply chain models showed the impact of resource availability, patient demand and lengthening the bottleneck on estimated costs.