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2017 ; 4
(ä): 92-101
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Global Manufacturing of CAR T Cell Therapy
#MMPMID28344995
Levine BL
; Miskin J
; Wonnacott K
; Keir C
Mol Ther Methods Clin Dev
2017[Mar]; 4
(ä): 92-101
PMID28344995
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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.
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