Application note: Cross-scale in situ raman monitoring of a cell culture bioprocess

This application note presents a cross-scale application as a follow-up to the process development study reported in Kaiser Application Note: Analysis of a Mammalian Cell Culture…

In mammalian-cell-based bioprocesses the most common critical process parameters (CPPs) include physical parameters (temperature, agitation rate, and dissolved oxygen [DO] levels) as well as chemical properties (pH, nutrients, and waste concentrations) and biochemical properties (cell count and viability).

Careful management of these CPPs is necessary to affect quality-assurance and maintain the tight parameters on product variability demanded by the FDA for GMP manufacturing.

Monitoring of these CPPs in situ has typically been limited to temperature, pressure, pH, and DO because sensors exist to measure these properties. Chemical and biochemical properties are typically measured off-line or at-line. However, the inherently time-consuming nature of off-line or at-line analyses are not compatible with real-time process control.