Product quality attributes such as glycosylation, size and charge variants play an important role, in the development of biotherapeutics, in mammalian cell culture processes with a targeted product profile. In an attempt to characterize the entire time-course of a fed-batch culture under different media conditions, a bioreactor autosampling device integrated with cell removal and sample retention systems and on-line instruments such as Patrol UPLC was developed to rapidly analyze the cell culture IPC as well as product quality changes in real time. This information can be rapidly translated for better process understanding and process control to enable optimization based on desired product quality profiles and is a very valuable tool in process development of robust cell culture processes.

Real time product quality analysis of mammalian cell culture processes

253rd National Meeting (2017)

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