T-Cell Manufacture for Treatment of Acute Lymphoblastic Leukemia

Adoptive T-cell therapy is a recent medical development that has shown clinical success in treating relapsed acute lymphoblastic leukemia (ALL), a common form of cancer with a poor prognosis. Ironically, the treatment’s greatest advantage is at the same time deterring large pharmaceutical companies from commercializing it. Adoptive T-cell therapy is successful in treating ALL largely because it takes a patient’s own cells and engineers them to fight the cancer. While the autologous nature of the treatment helps to incorporate the engineered T-cells into the patient’s body, it also makes each treatment patient-specific. This does not fit into the paradigm of large pharmaceutical companies, who want “off the shelf” drugs. Critics claim that adoptive T-cell therapy is a “boutique” treatment that is too costly and too impractical to commercialize. Our group performed a profitability analysis on a commercial-scale T-cell manufacturing facility based in Philadelphia and found that it could in fact be profitable. Furthermore, we pinpointed a cell separation step in the current procedure that was not optimal. We modeled the separation and determined an optimal operating protocol that would decrease the failure rate from 10% to 1%, increasing profitability in our facility by 25 million dollars.