The success of genetically engineered T-cells modified with a chimeric antigen receptor as an adoptive cell immunotherapy and the subsequent last regulatory approvals of products based on this therapy are leading to a crescent number of both academic and pharmaceutical industry clinical trials testing new approaches of this "living drugs". The aim of this review is to outline the latest developments and regulatory considerations in this field, with a particular emphasis to differences and similarities between academic and industry approaches and the role they should play to coexist and move forward together. To do that, the main considerations for the manufacturing process are firstly discussed, from the chimeric antigen receptor design to final production steps, passing through ex vivo T-cell handling, gene delivery methods, patient´s final product infusion observations or possible associated side effects of this treatment.

中文翻译：

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CART制造过程以及学院与制药公司合作的原因。

用嵌合抗原受体修饰的基因工程T细胞作为过继细胞免疫疗法的成功以及基于该疗法的产品的最后监管批准，导致学术界和制药行业的新月临床试验都在不断增加，以测试这种新方法“生活毒品”。这篇综述的目的是概述该领域的最新发展和监管方面的考虑，特别强调学术和行业方法之间的差异和相似之处，以及它们在共存和共同前进中应发挥的作用。为此，首先讨论了制造过程的主要考虑因素，从嵌合抗原受体设计到最终生产步骤，再经过离体T细胞处理，基因传递方法，