Standardizing CAR-T therapy: Getting it scaled up

Dai Xiaofeng; Mei Yi; Cai Dongyan; Han Weidong

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Standardizing CAR-T therapy: Getting it scaled up

机译：标准化Car-T治疗：缩小了

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CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.

机译：Car-T治疗，接枝单克隆抗体对T细胞的特异性以靶向某些癌细胞，已被认为是2017年FDA证明的两种Car-T产品所证明的癌症控制的有希望的治疗方法。然而， Car-T治疗的独特异质性限制了其在有限数量的机构中的生产，并使其成为精品疗法。通过审查围绕商业规模生产的卓越问题，我们得出结论，在不牺牲其个性化性质的情况下，实现批量生产的汽车-T治疗是在下一代精密医学中制作CAR-T一个关键因素的全球挑战，这可以通过标准化7个突出因素来实现，这些因素集体确定汽车-T制造规模。

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来源
《Biotechnology Advances: An International Review Journal》 |2019年第1期|共7页
作者
Dai Xiaofeng; Mei Yi; Cai Dongyan; Han Weidong;
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作者单位

Jiangnan Univ Wuxi Sch Med Wuxi Peoples R China;

Jiangnan Univ Sch Biotechnol Wuxi Peoples R China;

Jiangnan Univ Affiliated Hosp Wuxi Canc Inst Wuxi Peoples R China;

Chinese Peoples Liberat Army Gen Hosp Biotherapeut Dept Dept Mol &

Immunol Res Beijing 100853 Peoples R China;

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原文格式 PDF
正文语种 eng
中图分类生物工程学（生物技术）;
关键词
Chimeric antigen receptor; Standardization; Manufacturing process; Source materials; Viral vectors; Ancillary reagents; Quality control; Post-treatment immune monitoring; Government regulation;

机译：嵌合抗原受体;标准化;制造过程;源材料;病毒载体;辅助试剂;质量控制;治疗后免疫监测;政府监管;

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专利

1. Standardizing CAR-T therapy: Getting it scaled up [J] . Dai Xiaofeng, Mei Yi, Cai Dongyan, Biotechnology Advances: An International Review Journal . 2019,第1期

机译：标准化Car-T治疗：缩小了
2. Psychometric Testing of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale Using Pooled Chemotherapy-Induced Peripheral Neuropathy Outcome Measures Standardization and Alliance for Clinical Trials in Oncology A151408 Study Data [J] . Smith Ellen M. Lavoie, Banerjee Tanima, Yang James J., Cancer nursing . 2019,第3期

机译：欧洲癌症癌症质量研究和治疗欧洲癌症质量的心理测试问卷 - 化疗诱导的周围神经病变20项规模使用池化疗诱导的周围神经病变结果测量肿瘤学中临床试验的标准化和联盟A151408研究数据
3. Standardized total average toxicity score: A scale- and grade-independent measure of late radiotherapy toxicity to facilitate pooling of data from different studies [J] . BarnettG.C., WestC.M.L., ColesC.E., International Journal of Radiation Oncology, Biology, Physics . 2012,第3期

机译：标准化总平均毒性评分：晚期放疗毒性的比例和等级独立度量，以方便汇总不同研究的数据
4. LEVERAGING BIOPROCESS PLATFORM TECHNOLOGY FOR THE DEVELOPMENT OF A ROBUST, SCALABLE, AND ECONOMIC MANUFACTURING PROCESS OF ALLOGENEIC CAR-T CELL THERAPY PRODUCTS [C] . Bernadette Dahlin Conference on advancing manufacture of cell and gene therapies . 2019

机译：充分利用生物过程平台技术开发鲁棒，可缩放且经济的异源CAR T细胞治疗产品生产过程
5. A Heavy-Chain-Only CAR-T Cell Therapy Elicits Comparable Antitumor Response Compared with Canonical CAR-T Cells [D] . Wang, Guanmeng . 2019

机译：与规范汽车-T细胞相比，仅重链的Cel-T细胞疗法引发了可比的抗肿瘤反应
6. Innovative CAR-T Cell Therapy for Solid Tumor; Current Duel between CAR-T Spear and Tumor Shield [O] . Yuna Jo, Laraib Amir Ali, Ju A Shim, 2020

机译：用于实体瘤的创新CAR-T细胞疗法; Car-T矛和肿瘤屏蔽之间的当前决斗
7. Psychometric Testing of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale Using Pooled Chemotherapy-Induced Peripheral Neuropathy Outcome Measures Standardization and Alliance for Clinical Trials in Oncology A151408 Study Data [O] . Ellen M. Lavoie Smith, Tanima Banerjee, James J. Yang, 2019

机译：欧洲癌症癌症质量研究和治疗欧洲癌症质量的心理测试问卷 - 化疗诱导的周围神经病变20项规模使用池化疗诱导的周围神经病变结果测量肿瘤学中临床试验的标准化和联盟A151408研究数据

Standardizing CAR-T therapy: Getting it scaled up

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