autologous; chimeric antigen receptor T cell; cell therapy products; CMC changes; production capacity; validation strategies; post-approval change management protocol 基金项目 2023 年中国药品监督管理研究会课题(2023-Y-Y-012) ...
autologous; chimeric antigen receptor T cell; cell therapy products; CMC changes; production capacity; validation strategies; post-approval change management protocol 自从首款嵌合抗原受体T 细胞(chimeric antigen receptor T cell,CAR-T cell)治疗产品被美国食品药品监督管理局(Food and Drug Administration,FDA)...
Although puzzling at first, we believe that the two scenarios cannot be compared as AdCAR T cells are stimulated during the initial production protocol. Interestingly, more recent developments in CAR T-cell production have focused on maintaining a more naïve-like phenotype, thereby conserving the...
CAR T-cell therapy has led to sustained remissions in populations of otherwise refractory patients and, more specifically, has demonstrated complete response rates of > 80–97% in certain B-cell malignancies such as acute lymphoblastic leukemia (ALL) [5,6]. Because of this clinical efficacy,...
For BCMA-CARs, the optimal cytokine condition for the expansion of CAR-T cell products is currently unknown. Moreover, whether IL-7 is beneficial or not to IL-15-driven CAR-T cell production is an unanswered question. In the present study, we compared how IL-2, IL-15 and a combination...
MC38 cells/ HEK-293T cells were transfected with the concentrated lentiviral supernatant and screening with puromycin, respectively. Mouse T cell transduction and culture T cells were derived from murine splenocytes using a magnetic bead-based selection method according to the manufacturers protocol ...
The first CAR T-cell manufacturing relies on a small number of T cells as a starting material which were transduced and then expanded by bead stimulation. The second protocol did not involve the bead stimulation, thus more cells and larger volumes of retroviral particles were necessary, but ...
(D) Mean fluorescence intensity (MFI) calculated for different CAR-T cells using mock T cells as a negative control reference: gBCAR (n = 6, gray), 6G4-gp350CAR (n = 7, blue), or 7A1-gp350CAR (n = 7, red). PBMCs from 3 different donors were used for CAR-T cell production...
CAR T CellsLeukemiaMinicircleSleeping BeautyTransposonNevertheless, the electroporation of two large-size plasmid vectors into T cells leads to high T cell toxicity and low gene transfer rates and has hindered the prevalent clinical application of the SB system. To circumvent these limitations, ...
(Supplementary Fig.5a). T cell proliferation in response to p32+glioma target cells was assessed by CellTracerTMViolet dilution assay (Fig.3b). Next, we determined the tumor-specific recognition of p32-expressing glioma cells by both intracytoplasmic IFN-γ production (FACS analysis, Fig.3c) ...