Abstract
Product aggregation is one side effect of rising yields due to process improvement and therefore accompanied with massive product loss during downstream processing (DSP). But it is already in literature described, that product aggregation also occurs during the fermentation process and is caused by various process operations [1]. Real-time bioprocess monitoring and thus on-line product quality control during upstream processing (USP) enables to address this issue during process development. For bioprocess control, 2D fluorescence spectroscopy in combination with chemometric modeling based on fluorescence signals derived from cells and medium components is a promising tool and described in literature [2]. Furthermore extrinsic fluorescence dyes are widely used to detect and quantify aggregated protein [3]. In this study, 2D fluorescence spectroscopy in combination with three different extrinsic fluorescence dyes were evaluated, in order to establish a process control tool which enables real-time product control during USP.
Highlights
Product aggregation is one side effect of rising yields due to process improvement and accompanied with massive product loss during downstream processing (DSP)
A common approach to analyze aggregated monoclonal antibody (mAb) in cell culture comprises the isolation of the mAb by protein A HPLC subsequently followed by size exclusion chromatography [1,4]
The signal derived from the cell culture medium and host cell proteins could be separated from mAb monomer and aggregate signal (Figure 1D)
Summary
Product aggregation is one side effect of rising yields due to process improvement and accompanied with massive product loss during downstream processing (DSP). It is already in literature described, that product aggregation occurs during the fermentation process and is caused by various process operations [1]. Real-time bioprocess monitoring and on-line product quality control during upstream processing (USP) enables to address this issue during process development. 2D fluorescence spectroscopy in combination with three different extrinsic fluorescence dyes were evaluated, in order to establish a process control tool which enables real-time product control during USP
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