高通量微型生物反应器的研究进展

High-Throughput Micro Bioreactor Development for Biopharmaceuticals

近年来,哺乳动物细胞培养技术发展迅猛,基于此技术的生物制药行业更是异军突起。在激烈的生物药市场竞争中,缩短研发时间和降低研发成本是制胜的关键。与传统的生物反应器相比,高通量微型生物反应器具有操作简单、运行通量高、实验重复性好等优点,可大大缩短研发周期,降低人力、物力成本,因此成为了生物制药行业最新的研究热点之一。目前,已成功应用于生物药物研发的微型生物反应器有Simcell^（TM）、Ambr 15^（TM）、Ambr 250^（TM）等,分别适用于工艺开发中的不同阶段。以上述三种微型生物反应器为例,介绍高通量微型反应器在哺乳动物细胞培养工艺开发中的研究现状及发展前景。

The development of biologics based on mammalian cell culture technologies has increasingly rapid advances for the pharmaceutical markets in the recent years. Economic concerns and time constraint as the critical factors and the driving force have accelerated bioprocess development of delivery of new biopharmaceutical drugs to market. Dramatically,advancement of semi-high-throughput micro-bioreactors in bioprocess development has shown a significant alternative for the conventional approaches due to automation,increased capability of throughput,and excellent parallel level compared to costly and laborious bench-top bioreactors. There are several commercially available micro scale bioreactors,such as Simcell^（TM）,Ambr 15^（TM） and Ambr 250^（TM）,being applied in different stages of cell culture development to enhance throughput. This research reviewed and summarized the strengths and challenges of high-throughput bioreactors for the mammalian cells culture,showing the potential as scale-down models for process development and further improvement in the future.