Eurofins Viracor Biopharma, Lenexa, KS 66219, USA.
Eurofins Pharma Bioanalytical Services, St. Charles, MO 63304, USA.
Int J Mol Sci. 2024 Sep 24;25(19):10263. doi: 10.3390/ijms251910263.
Monitoring chimeric antigen redirected (CAR) T-cells post-infusion in clinical trials is a specialized application of flow cytometry. Unlike the CAR T-cell monitoring for individual patients conducted in clinical laboratories, the data generated during a clinical trial will be used not only to monitor the therapeutic response of a single patient, but determine the success of the therapy itself, or even of an entire class of therapeutic compounds. The data, typically acquired at multiple testing laboratories, will be compiled into a single database. The data may also be used for mathematical modeling of cellular kinetics or to identify predictive biomarkers. With the expanded context of use, a robust, standardized assay is mandatory in order to generate a valuable and reliable data set. Hence, the requirements for assay validation, traceable calibration, technology transfer, cross-instrument standardization and regulatory compliance are high.
在临床试验中监测嵌合抗原受体（CAR）T 细胞的输注后情况是流式细胞术的一个专业应用。与在临床实验室中为单个患者进行的 CAR T 细胞监测不同，临床试验期间生成的数据不仅将用于监测单个患者的治疗反应，还将用于确定治疗本身甚至整个治疗化合物类别的成功。这些数据通常由多个检测实验室采集，并将汇总到一个数据库中。这些数据还可用于细胞动力学的数学建模或识别预测性生物标志物。随着使用范围的扩大，为了生成有价值且可靠的数据集，必须使用强大且标准化的检测方法。因此，检测方法验证、可追溯校准、技术转移、仪器间标准化和法规遵从性的要求很高。
