1. Global Manufacturing of CAR T Cell Therapy
- Author
-
Keith Wonnacott, James Miskin, Christopher Hunt Keir, and Bruce L. Levine
- Subjects
0301 basic medicine ,lcsh:QH426-470 ,medicine.medical_treatment ,T lymphocytes ,Review ,Biology ,CD19 ,Viral vector ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,Genetics ,medicine ,Global manufacturing ,Vector (molecular biology) ,lcsh:QH573-671 ,Molecular Biology ,B cell ,chimeric antigen receptor ,lcsh:Cytology ,lentiviral vector ,Immunotherapy ,Chimeric antigen receptor ,lcsh:Genetics ,manufacturing ,030104 developmental biology ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Immunology ,biology.protein ,Molecular Medicine ,global regulatory environment - Abstract
Immunotherapy using chimeric antigen receptor-modified T cells has demonstrated high response rates in patients with B cell malignancies, and chimeric antigen receptor T cell therapy is now being investigated in several hematologic and solid tumor types. Chimeric antigen receptor T cells are generated by removing T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, which reprograms the T cells to target tumor cells. As chimeric antigen receptor T cell therapy moves into later-phase clinical trials and becomes an option for more patients, compliance of the chimeric antigen receptor T cell manufacturing process with global regulatory requirements becomes a topic for extensive discussion. Additionally, the challenges of taking a chimeric antigen receptor T cell manufacturing process from a single institution to a large-scale multi-site manufacturing center must be addressed. We have anticipated such concerns in our experience with the CD19 chimeric antigen receptor T cell therapy CTL019. In this review, we discuss steps involved in the cell processing of the technology, including the use of an optimal vector for consistent cell processing, along with addressing the challenges of expanding chimeric antigen receptor T cell therapy to a global patient population.
- Published
- 2016