Sensebé Luc, Bourin Philippe, Tarte Karin
Etablissement Français du Sang Centre-Atlantique, Tours, France.
Hum Gene Ther. 2011 Jan;22(1):19-26. doi: 10.1089/hum.2010.197. Epub 2010 Dec 19.
Because of their multi/pluripotency and immunosuppressive properties mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs has led to production processes that need to be in accordance with Good Manufacturing Practice (GMP). In cellular therapy, safety remains one of the main concerns and refers to donor validation, choice of starting material, processes, and the controls used, not only at the batch release level but also during the development of processes. The culture processes should be reproducible, robust, and efficient. Moreover, they should be adapted to closed systems that are easy to use. Implementing controls during the manufacturing of clinical-grade MSCs is essential. The controls should ensure microbiological safety but also avoid potential side effects linked to genomic instability driving transformation and senescence or decrease of cell functions (immunoregulation, differentiation potential). In this rapidly evolving field, a new approach to controls is needed.
由于间充质干/基质细胞（MSCs）具有多能/多向分化潜能和免疫抑制特性，它们是治疗免疫疾病和组织修复的重要工具。MSCs使用的增加促使生产过程需要符合药品生产质量管理规范（GMP）。在细胞治疗中，安全性仍然是主要关注点之一，涉及供体验证、起始材料的选择、过程以及所使用的控制措施，不仅在批次放行阶段，而且在工艺开发过程中。培养过程应具有可重复性、稳健性和高效性。此外，它们应适用于易于使用的封闭系统。在临床级MSCs制造过程中实施控制至关重要。这些控制应确保微生物安全性，同时避免与基因组不稳定导致的转化、衰老或细胞功能（免疫调节、分化潜能）降低相关的潜在副作用。在这个快速发展的领域，需要一种新的控制方法。
