Real-time MAM Readout
The LC-MS integrated µSI process analyzer system was introduced into a manufacturing facility and connected to a process stream for continuous product quality monitoring. The robustness of the system was first verified by processing reference standard daily for 6 days, and the results in Figure 6a were comparable to off-line analysis. The system was then programmed for daily bioreactor sampling. As depicted inFigure 6b , each bioreactor sample was bracketed by two reference standards as an assay acceptance check, and product deamidation and clips were measured. The staggering of sample processing and LC-MS analyses resulted in a throughput of approximately 7 samples per day.