自體CAR-T細胞過繼轉移可誘導復發/難治性血液惡性腫瘤患者的持續緩解，但是同時也存在一系列問題：1. 重癥癌癥病人，可能無法獲取自體T細胞進行CAR-T生產 2. 自體CAR-T細胞的異質性可能帶來不可預測的臨床反應。

Precision BioScience通過其專利ARCUS基因編輯技術平臺，使用健康人T細胞建立通用CAR-T細胞，獲得了生物制藥商Baxalta17億美金投資。通過基因編輯去除細胞原有TCR，避免內源TCR引起的移植排斥反應，通過基因編輯，改變免疫耐受，提高CAR-T到腫瘤局部的能力，且具有保證批間一致性的優勢。

Precision BioScience 在2018年三月份Best Practice & Research Clinical Haematology上發表了其off-the-Shelf T細胞治療技術體系Off the shelf T cell therapies for hematologic malignancies。

Off the shelf T cell技術流程：文章系統介紹了Off the shelf T cell技術

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全自動的微流體ELISA系統來替代傳統ELISA方法。

Ella在細胞功能分析及細胞因子風暴檢測的三大優勢：

1. 超敏：IL-6等可達fg/ml，為傳統ELISA 10-100倍

2. 快速：從樣本處理到結構，90mins之內

3.全自動：降低實驗間CV

之前，Ella 系統已經被Novartis和Kite Pharma等細胞治療的公司用作細胞功能質量控制。