Quality Control in the Application of Flow Cytometry to Studies of Environmentally-Induced Genetic Damage

2009 ◽  
pp. 401-401-12
Author(s):  
CD McCreedy ◽  
JP Robinson ◽  
CE Dallas ◽  
CH Jagoe
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
Genetic Damage

scholarly journals Establishment and validation of in-house cryopreserved CAR/TCR-T cell flow cytometry quality control

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yihua Cai ◽  
Michaela Prochazkova ◽  
Chunjie Jiang ◽  
Hannah W. Song ◽  
Jianjian Jin ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
T Cells ◽  
T Cell ◽  
Critical Role ◽  
Transduction Efficiency ◽  
Quality Controls ◽  
Car T Cells ◽  
Car T ◽  
Vector Identity

Abstract Background Chimeric antigen receptor (CAR) or T-cell receptor (TCR) engineered T-cell therapy has recently emerged as a promising adoptive immunotherapy approach for the treatment of hematologic malignancies and solid tumors. Multiparametric flow cytometry-based assays play a critical role in monitoring cellular manufacturing steps. Since manufacturing CAR/TCR T-cell products must be in compliance with current good manufacturing practices (cGMP), a standard or quality control for flow cytometry assays should be used to ensure the accuracy of flow cytometry results, but none is currently commercially available. Therefore, we established a procedure to generate an in-house cryopreserved CAR/TCR T-cell products for use as a flow cytometry quality control and validated their use. Methods Two CAR T-cell products: CD19/CD22 bispecific CAR T-cells and FGFR4 CAR T-cells and one TCR-engineered T-cell product: KK-LC-1 TCR T-cells were manufactured in Center for Cellular Engineering (CCE), NIH Clinical Center. The products were divided in aliquots, cryopreserved and stored in the liquid nitrogen. The cryopreserved flow cytometry quality controls were tested in flow cytometry assays which measured post-thaw viability, CD3, CD4 and CD8 frequencies as well as the transduction efficiency and vector identity. The long-term stability and shelf-life of cryopreserved quality control cells were evaluated. In addition, the sensitivity as well as the precision assay were also assessed on the cryopreserved quality control cells. Results After thawing, the viability of the cryopreserved CAR/TCR T-cell controls was found to be greater than 50%. The expression of transduction efficiency and vector identity markers by the cryopreserved control cells were stable for at least 1 year; with post-thaw values falling within ± 20% range of the values measured at time of cryopreservation. After thawing and storage at room temperature, the stability of these cryopreserved cells lasted at least 6 h. In addition, our cryopreserved CAR/TCR-T cell quality controls showed a strong correlation between transduction efficiency expression and dilution factors. Furthermore, the results of flow cytometric analysis of the cryopreserved cells among different laboratory technicians and different flow cytometry instruments were comparable, highlighting the reproducibility and reliability of these quality control cells. Conclusion We developed and validated a feasible and reliable procedure to establish a bank of cryopreserved CAR/TCR T-cells for use as flow cytometry quality controls, which can serve as a quality control standard for in-process and lot-release testing of CAR/TCR T-cell products.

scholarly journals A Questionnaire Survey of Quality Control of Flow Cytometry in Korea and Development of New Quality-Control Materials

2017 ◽  
Vol 39 (4) ◽  
pp. 168-177
Author(s):  
Jae Seong Shim ◽  
Sang Mi Hwang ◽  
In Suk Kim ◽  
Sang Yong Shin ◽  
Ju Young Oh ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
Questionnaire Survey ◽  
Quality Control Materials ◽  
Control Of Flow

Effective in-process quality control of platelet concentrates (PC) by flow cytometry

1996 ◽  
pp. 451-454 ◽  
Author(s):  
K. Gutensohn ◽  
U. Cassens ◽  
C. Peters ◽  
I. Ganschow ◽  
W. Zeller ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
Process Quality ◽  
Platelet Concentrates

scholarly journals A scalable platform for clinical immunophenotyping: assay design and quality control for high complexity flow cytometry

2015 ◽  
Vol 3 (Suppl 2) ◽  
pp. P251
Author(s):  
Yoshinobu Koguchi ◽  
Tanisha Meeuwsen ◽  
Iliana Gonzalez ◽  
William Miller ◽  
Keith S Bahjat
Keyword(s):  
Flow Cytometry ◽  
Quality Control ◽  
High Complexity ◽  
Assay Design
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