高通量微型生物反应器在生物制药行业中的应用

Application of high-throughput miniature bioreactors in biopharmaceuticals

随着生物制药行业的快速发展,近年来高通量微型生物反应器系统得到较为广泛的应用。高通量微型生物反应器系统具有体积小、高通量、可放大性等优点,同时具有在线分析检测和过程反馈控制功能。目前,高通量微型生物反应器主要用于细胞株筛选、工艺优化及工艺表征等方面。其高通量结合实验设计开展实验研究,可大大缩短产品研发周期,提高工艺稳健性及产品质量可控性,加快研发项目进入临床及商业化的步伐。本文主要介绍了目前常见的几种高通量微型生物反应器系统,并以Ambr系统为例,介绍了高通量微型生物反应器系统在生物制药行业中的应用。

With the rapid development of biopharmaceutical industry, high-throughput miniature bioreactor systems have been widely used in recent years. The high-throughput miniature bioreactor system has the advantages of small size, high-throughput and good scalability, as well as the capability of on-line analysis and feedback control. At present, it is mainly applied in cell line selection, process optimization and process characterization. High-throughput technologies combining with experimental design can shorten the product development timelines significantly, improve the process robustness and product quality control, and accelerate the delivery of projects into clinical and commercial phase. This review mainly describes several common high-throughput miniature bioreactor systems and describes their applications in the biopharmaceutical industry, using Ambr system as an example.