细胞培养上游强化工艺的应用

Application of process intensification in upstream process development

近年来,生物制品市场需求越来越转向有效、安全和可负担得起。抗体生产的工艺策略一直在追求平台的改进,以期克服传统批培养工艺成本高、产量低的局限性。其中上游强化工艺在提高生物制造的生产力和降低成本以及提高厂房利用率等方面显示出巨大的潜力。文中主要讨论了细胞培养强化工艺的最新技术,从N-1种子培养阶段和N生物反应器生产阶段两个方面阐述灌流培养(Perfusion)、高密度接种培养、浓缩补料批培养(CFB)在上游工艺中的最新应用。

In recent years,with an increasing demand for efficacious,safe,and affordable biological products to the market,process strategies for antibody production have been pursuing platform improvements to overcome the high cost and low yield of conventional batch manufacturing.Process intensification shows great potential to increase productivity,plant utilization rate and reduce costs in biomanufacturing.This review mainly discusses the state-of-the-art cell culture upstream intensification process,including both the N-1 seeding stage and the N bioreactor production stage.This paper also describes the latest applications of Perfusion,high-density inoculum culture and concentrated fed-batch(CFB)in the upstream.