Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, Texas, USA.
Cancer Gene Ther. 2015 Mar;22(2):67-71. doi: 10.1038/cgt.2014.71. Epub 2015 Jan 30.
Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices-a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use.
遵守食品和药物管理局关于启动新细胞治疗产品早期临床试验的规定，往往对新的研究者构成障碍。最大的障碍之一是要求根据现行良好生产规范（GMP）制造治疗产品——这一系统通常既不为基础研究人员所理解，也不为临床医生所理解。本文回顾了在为治疗用途制造基因修饰 T 细胞时必须解决的要点。
