Abstract：
Scale-down models (SDM) are pivotal tools for process understanding and improvement to accelerate the development of vaccines from laboratory research to global commercialization. In this study, a 3 L SDM representing a 50 L scale Vero cell culture process of a live-attenuated virus vaccine using microcarriers was developed and qualified based on the constant impeller power per volume principle. Both multivariate data analysis (MVDA) and the traditional univariate data analysis showed comparable and equivalent cell growth, metabolic activity, and product quality results across scales. Computational fluid dynamics simulation further confirmed similar hydrodynamic stress between the two scales.
摘要：
按比例缩小模型（SDM）是过程理解和改进的关键工具，可加速从实验室研究到全球商业化的疫苗开发。在这项研究中,3LSDM代表使用微载体的减毒活疫苗的50L规模Vero细胞培养过程，并基于恒定叶轮功率/体积原理进行了鉴定。多变量数据分析（MVDA）和传统的单变量数据分析都显示出可比和等效的细胞生长，代谢活动，和跨尺度的产品质量结果。计算流体动力学模拟进一步证实了两个尺度之间相似的流体动力学应力。
