Cell and gene therapies have demonstrated excellent clinical results across a range of indications with chimeric antigen receptor (CAR)–T cell therapies among the first to reach market. Although these therapies are currently manufactured using patient-derived cells, therapies using healthy donor cells are in development, potentially offering avenues toward process improvement and patient access. An allogeneic model could significantly reduce aggregate cost of goods sold (COGS), potentially improving market penetration of these life-saving treatments.
A new paper published in Cytotherapy, co-authored by Richard Harrison (Cell and Gene Therapy Catapult), Ezequiel Zylberberg (Akron Biotechnology), Simon Ellison (World Courier), and Bruce Levine (University of Pennsylvania), maps allogeneic CAR T manufacturing and delivery processes, identifying how allogenic models reliant upon donor cells can yield significant COGs reductions vis-à-vis autologous models, whereby a patient’s own cells are extracted, manipulated ex vivo and then re-infused. Furthermore, the paper models the globalization of allogeneic CAR T manufacturing under a variety of scenarios, examining how changes in the industry’s structure might ultimately impact cost of goods.
Figure 3. COGs between autologous and allogeneic CAR-T cell manufacturing processes. The process modelled used an 8- (auto) and 10- (allo) day manufacturing process with an identical facility structure and QC panel. Staffing levels were similar but additional operators were present for the autologous process. Percentages shown as portion of total production COGs.
Source: Harrison RP, Zylberberg E, Ellison S, Levine BL. Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods. Cytotherapy, 2019; 00, pg. 1-10.
The paper finds that the largest cost drivers in the production of an allogeneic CAR T therapy are ancillary materials and quality control, with staff and facility costs being marginal overall. As such, offshore production is likely to remain limited in the cell and gene therapy industry unless said production is directed towards the local or regional market. In the long run, the cost of cross-border transportation and trend towards greater process automation will erode any savings associated with wage arbitrage. For more details on the study and its findings, please read the full Cytotherapy paper, available here.