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METHODS FOR ASSESSING THE SUITABILITY OF TRANSDUCED T-CELLS FOR INTRODUCTION

机译:评估导入的T细胞的适宜性的方法

摘要

The invention relates to the analysis of supernatants of vectors suitable for transduction of T cells, intended for administration to a human individual. The invention also relates to methods for analyzing transduced T cells for administration to a human subject. The invention relates to a method for analyzing a genetically modified T cell to detect contamination, where a genetically modified T cell contains a nucleic acid encoding a chimeric antigen receptor (CAR), where CAR contains an antigen binding domain, a transmembrane domain, a co-stimulatory signal region and a signal domain. In one embodiment, the contamination is at least contamination selected from the group consisting of endotoxin, mycoplasma, lentivirus replication component (RCL), p24, nucleic acid VSV-G, HN-gag, residual granules coated with anti-antibodies CD3 / CD28, mouse antibodies, mixed human serum, bovine serum albumin, bovine serum, culture medium components, cell or plasmid vector packaging components, bacteria and fungi.
机译:本发明涉及对适于向人施用的适于T细胞转导的载体的上清液的分析。本发明还涉及分析转导的T细胞以施用于人受试者的方法。本发明涉及一种分析遗传修饰的T细胞以检测污染的方法,其中遗传修饰的T细胞包含编码嵌合抗原受体(CAR)的核酸,其中CAR包含抗原结合结构域,跨膜结构域,co -刺激信号区域和信号域。在一个实施方案中,所述污染至少是选自以下的污染:内毒素,支原体,慢病毒复制组分(RCL),p24,核酸VSV-G,HN-gag,包被有抗CD3 / CD28抗体的残留颗粒,小鼠抗体,混合的人血清,牛血清白蛋白,牛血清,培养基成分,细胞或质粒载体包装成分,细菌和真菌。

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