Kirouac Daniel C, Zandstra Peter W
Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON M5S 3E1, Canada.
Cell Stem Cell. 2008 Oct 9;3(4):369-81. doi: 10.1016/j.stem.2008.09.001.
Stem cells have emerged as the starting material of choice for bioprocesses to produce cells and tissues to treat degenerative, genetic, and immunological disease. Translating the biological properties and potential of stem cells into therapies will require overcoming significant cell-manufacturing and regulatory challenges. Bioprocess engineering fundamentals, including bioreactor design and process control, need to be combined with cellular systems biology principles to guide the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner. The step-wise implementation of these bioengineering strategies will enhance cell therapy product quality and safety, expediting clinical development.
干细胞已成为生物工艺中生产用于治疗退行性、遗传性和免疫性疾病的细胞和组织的首选起始材料。要将干细胞的生物学特性和潜力转化为治疗方法，需要克服重大的细胞制造和监管挑战。生物工艺工程基础，包括生物反应器设计和过程控制，需要与细胞系统生物学原理相结合，以指导能够以安全、稳健且具有成本效益的方式生产基于细胞的产品的下一代技术的开发。逐步实施这些生物工程策略将提高细胞治疗产品的质量和安全性，加速临床开发。
