诱导多能干细胞
重编程
商业化
再生医学
良好制造规范
过程(计算)
风险分析(工程)
人诱导多能干细胞
计算机科学
业务
医学
工程类
干细胞
运营管理
细胞
生物
胚胎干细胞
营销
基因
生物化学
操作系统
遗传学
监管事务
作者
Mehdi Dashtban,Krishna M. Panchalingam,Mehdi Shafa,Behnam Ahmadian Baghbaderani
出处
期刊:Methods in molecular biology
日期:2020-01-01
卷期号:: 179-198
被引量:11
标识
DOI:10.1007/7651_2020_288
摘要
The development of reprogramming technology to generate human induced pluripotent stem cells (iPSCs) has tremendously influenced the field of regenerative medicine and clinical therapeutics where curative cell replacement therapies can be used in the treatment of devastating diseases such as Parkinson’s disease (PD) and diabetes. In order to commercialize these therapies to treat a large number of individuals, it is important to demonstrate the safety and efficacy of these therapies and ensure that the manufacturing process for iPSC-derived functional cells can be industrialized at an affordable cost. However, there are a number of manufacturing obstacles that need to be addressed in order to meet this vision. It is important to note that the manufacturing process for generation of iPSC-derived specialized cells is relatively long and fairly complex and requires differentiation of high-quality iPSCs into specialized cells in a controlled manner. In this chapter, we have summarized our efforts to address the main challenges present in the industrialization of iPSC-derived cell therapy products with focus on the development of a current Good Manufacturing Practice (cGMP)-compliant iPSC manufacturing process, a comprehensive iPSC characterization platform, long-term stability of cGMP compliant iPSCs, and innovative technologies to address some of the scale-up challenges in establishment of iPSC processing in 3D computer-controlled bioreactors.
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