A comparison of different intensified upstream processes highlighting
the advantage of WuXiUP in improved product quality and simplified
downstream process
Abstract
WuXiUP, 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 bispecfic 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 report, case studies of the
production of different pharmaceutical proteins using two high producing
and intensified culture modes of the WuXiUP 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 WuXiUP and CFB outperformed TFB regarding to
volumetric productivity. Additionally, distinctive advantages in product
quality profiles, such as charge variant, fragmentation etc., in
the WuXiUP process are revealed, and therefore a simplified downstream
purification process with only two chromatographic steps can be
developed to deliver the target product at a satisfactory purity.