自體CAR-T細(xì)胞過(guò)繼轉(zhuǎn)移可誘導(dǎo)復(fù)發(fā)/難治性血液惡性腫瘤患者的持續(xù)緩解，但是同時(shí)也存在一系列問(wèn)題：1. 重癥癌癥病人，可能無(wú)法獲取自體T細(xì)胞進(jìn)行CAR-T生產(chǎn) 2. 自體CAR-T細(xì)胞的異質(zhì)性可能帶來(lái)不可預(yù)測(cè)的臨床反應(yīng)。

Precision BioScience通過(guò)其專利ARCUS基因編輯技術(shù)平臺(tái)，使用健康人T細(xì)胞建立通用CAR-T細(xì)胞，獲得了生物制藥商Baxalta17億美金投資。通過(guò)基因編輯去除細(xì)胞原有TCR，避免內(nèi)源TCR引起的移植排斥反應(yīng)，通過(guò)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(yōu)勢(shì)。

Precision BioScience 在2018年三月份Best Practice & Research Clinical Haematology上發(fā)表了其off-the-Shelf T細(xì)胞治療技術(shù)體系Off the shelf T cell therapies for hematologic malignancies。

Off the shelf T cell技術(shù)流程：文章系統(tǒng)介紹了Off the shelf T cell技術(shù)

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(dòng)的微流體ELISA系統(tǒng)來(lái)替代傳統(tǒng)ELISA方法。

Ella在細(xì)胞功能分析及細(xì)胞因子風(fēng)暴檢測(cè)的三大優(yōu)勢(shì)：

1. 超敏：IL-6等可達(dá)fg/ml，為傳統(tǒng)ELISA 10-100倍

2. 快速：從樣本處理到結(jié)構(gòu)，90mins之內(nèi)

3.全自動(dòng)：降低實(shí)驗(yàn)間CV

之前，Ella 系統(tǒng)已經(jīng)被Novartis和Kite Pharma等細(xì)胞治療的公司用作細(xì)胞功能質(zhì)量控制。