微小型生物反应器及其在生物医药领域的应用展望

Application of micro- and mini-bioreactors in biomedicine development and production

摘要:

微小型生物反应器体积微小但在线分析检测和过程控制功能媲美台式装备。其核心支撑技术包括一次性材料及微加工技术、非接触式光学传感器、自动化以及实验设计 (DOE)、数据分析软件与过程控制的整合。由于体积微小、湍流程度和单位能耗较低，微小型反应器内的混合、传质、剪切特性与工业规模设备有一定的区别。现阶段微小型生物反应器主要用于菌株和细胞系筛选和工艺优化，在实现高通量工艺的同时确保了数据的丰度，对缩短研发周期和加速产品上市，尤其是在应对突发性传染性疾病方面有着重要的意义。未来，精准医疗概念的落实也依赖功能柔性化的微小型生物反应器系统。

Abstract:

Micro- and mini-bioreactors are characterized by their miniature working volume and comprehensive monitoring of process data, e.g., biomass, pH, dissolved oxygen, and fluorescence that are on par with conventional bench-top systems. The technical advancements of micro- and mini-bioreactors are supported by single-use material and micro-manufacturing, non-invasive optical sensors, automation such as industrial robotics and the integration of design of experiment software with data acquisition and process control. Owing to the miniature scales, micro-bioreactors typically feature lower turbulence intensity and energy dissipation rate, resulting in different mass transfer, mixing and shear conditions as compared to industrial scale equipment. Mini-bioreactors, nevertheless, are closer to large vessels. Micro- and mini-bioreactors are used mostly in screening and process development nowadays, owing to their combined high throughput and richness of data. They are also the hardware that will enable “precision medicine” in the near future.