off-the-Shelf T细胞治疗技术
自体CAR-T细胞过继转移可诱导复发/难治性血液恶性肿瘤患者的持续缓解，但是同时也存在一系列问题：1. 重症癌症病人，可能无法获取自体T细胞进行CAR-T生产 2. 自体CAR-T细胞的异质性可能带来不可预测的临床反应。
Precision BioScience通过其ZLARCUS基因编辑技术平台，使用健康人T细胞建立通用CAR-T细胞，获得了生物制药商Baxalta17亿美金投资。通过基因编辑去除细胞原有TCR，避免内源TCR引起的移植排斥反应，通过基因编辑，改变免疫耐受，提高CAR-T到肿瘤局部的能力，且具有保证批间一致性的优势。
Precision BioScience 在2018年三月份Best Practice & Research Clinical Haematology上发表了其off-the-Shelf T细胞治疗技术体系Off the shelf T cell therapies for hematologic malignancies。
Off the shelf T cell技术流程：
文章系统介绍了Off the shelf T cell技术
1. Gene editing for production of allogeneic CAR-T cells from unrelated healthy donor cells
2. Allogeneic CAR-T cells with targeted CAR insertion by homologous recombination
3. Additional gene edits to reduce immunogenicity and resist suppression within the tumor microenvironment
4. Allogeneic CAR-T cell manufacturing
5. Allogeneic CAR-T cell analytical methods
5.1 Viability and cell count
5.2 Cellular phenotype
5.3 Functional analysis
Traditionally, functional response of any T cell to antigenic challenges is estimated by cytokine production, cytotoxic activity, and T cell proliferation. Interferon gamma is a classical target to analyze T cell potency and is utilized as indicative of the biological functionality of manufactured T cell products. Conventional ELISA is a time-consuming procedure which requires well trained personnel or additional expenses for the automatization of the entire procedure. The Microfluidic Simple Plex cartridge-based assay on the ELLA instrument (ProteinSimple, San Jose, CA) may be a viable alternative to traditional ELISA. The entire procedure is handsfree and take approximately 90 min for readout.
在功能分析（ Functional analysis）方面Precision Medicine特地提到了使用Ella全自动的微流体ELISA系统来替代传统ELISA方法。
Ella在细胞功能分析及细胞因子风暴检测的三大优势：
1. 超敏：IL-6等可达fg/ml，为传统ELISA 10-100倍
2. 快速：从样本处理到结构，90mins之内
3.全自动：降低实验间CV
之前，Ella 系统已经被Novartis和Kite Pharma等细胞治疗的公司用作细胞功能质量控制。
