Abstract：
WuXiUPTM, WuXi Biologics\' Ultra-high Productivity platform, is an intensified and integrated continuous bioprocess platform developed for production of various biologics including monoclonal antibodies, fusion proteins, and bispecific antibodies. This process technology platform has manifested its remarkable capability in boosting the volumetric productivity of various biologics and has been implemented for large-scale clinical material productions. In this paper, case studies of the production of different pharmaceutical proteins using two high-producing and intensified culture modes of WuXiUPTM and the concentrated fed-batch (CFB), as well as the traditional fed-batch (TFB) are discussed from the perspectives of cell growth, productivity, and protein quality. Both WuXiUPTM and CFB outperformed TFB regarding volumetric productivity. Additionally, distinctive advantages in product quality profiles in the WuXiUPTM process, such as reduced acidic charge variants and fragmentation, are revealed. Therefore, a simplified downstream purification process with only two chromatographic steps can be developed to deliver the target product at a satisfactory purity and an extremely-high yield.
摘要：
乌西乌托姆,无锡生物制品超高生产率平台，是一个强化和集成的连续生物过程平台，开发用于生产各种生物制品，包括单克隆抗体，融合蛋白,和双特异性抗体。该工艺技术平台在提高各种生物制剂的体积生产率方面表现出其卓越的能力，并已用于大规模临床材料生产。在本文中,使用WuXiUPTM和浓缩补料分批（CFB）的两种高产和强化培养模式生产不同药物蛋白的案例研究，以及传统的补料分批（TFB）从细胞生长的角度进行了讨论，生产力,和蛋白质质量。WuXiUPTM和CFB在容积生产率方面均优于TFB。此外,乌西乌普特工艺在产品质量方面的独特优势，如减少酸性电荷变体和片段化，被揭露。因此,可以开发仅具有两个色谱步骤的简化的下游纯化方法,从而以令人满意的纯度和极高的产率提供目标产物。
