面向大规模扩增的 NK 细胞可放大生产工艺开发

We developed a process for expanding iPCS-derived NK cells using a stirred culture system. The NK cell stimulation process with agonist antibodies and expansion process were repeated, and the cell expansion and quality of iPCS-derived NK cells were evaluated. Scale-up factors were evaluated using an aerated stirred bioreactor, and process scale-up was performed from 1 L to 10 L bioreactors.

iPCS-derived NK cells showed higher cell expansion in stirred cultures than in static cultures. By repeated stimulation and expansion processes, iPCS-derived NK cells expanded 1000-fold with comparable cell expansion and quality. iPCS-derived NK cells could be scaled up from 1 L to 10 L aerated stirred bioreactors with comparable cell expansion and quality.

Through systematic process evaluation and optimization, we demonstrated that iPCS-derived NK cells can be expanded in a scalable aerated stirred bioreactor.