Clinical manufacturing of CAR T cells: foundation of a promising therapy

• Main Authors: Xiuyan Wang, Isabelle Rivière
• Format: Article
• Language: English
• Published: Elsevier 2016-01-01
• Series: Molecular Therapy: Oncolytics
• Online Access: http://www.sciencedirect.com/science/article/pii/S2372770516300390

The treatment of cancer patients with autologous T cells expressing a chimeric antigen receptor (CAR) is one of the most promising adoptive cellular therapy approaches. Reproducible manufacturing of high-quality, clinical-grade CAR-T cell products is a prerequisite for the wide application of this technology. Product quality needs to be built-in within every step of the manufacturing process. We summarize herein the requirements and logistics to be considered, as well as the state of the art manufacturing platforms available. CAR-T cell therapy may be on the verge of becoming standard of care for a few clinical indications. Yet, many challenges pertaining to manufacturing standardization and product characterization remain to be overcome in order to achieve broad usage and eventual commercialization of this therapeutic modality.