From clinical proof-of-concept to commercialization of CAR T cells. Issue 4 (April 2018) - Calmels, Boris
Highlights: Feasibility to manufacture CAR T cells supporting Phase I/II trials has been shown. Commercialization requires an open dialog with regulatory agencies across states. Manufacturing off-the-shelf products is an alternative to personalized CAR T cells. Point-of-care production can help reduce challenges facing centralized manufacturing. CAR T cells targeting new disease conditions could favor their commercial success. Abstract : The development of CAR T cells currently represents an exciting opportunity to convert the already published clinical successes observed in clinical trials into commercially available efficient therapies. However, the path toward successful commercialization is still hindered by many hurdles. Here, we review such issues as: the need for structured collaborations between hospital collection and clinical facilities and industry manufacturing facilities to streamline the supply chain; necessity for uniform and efficient medical procedures to cope with severe toxicities associated with CAR T cells; and absolute need to define an economical and sustainable model for manufacturers and payers. The fast pace at which the field is evolving requires careful assessments for the benefit of patients.