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Whitepaper: Simultaneous in situ real-time monitoring of a bioprocess
1 April 2016 • Author(s): Kaiser Optical Systems Inc.
In mammalian-cell-based bioprocesses the most common critical process parameters (CPPs) include physical parameters (temperature, pressure, dissolved oxygen [DO] levels) as well as chemical properties (pH, concentrations of both substrates and byproducts) and biochemical properties (cell number and viability, cell physiology).
Careful control of these CPPs is necessary to effect quality-assurance and maintain the tight parameters on product variability demanded by the FDA. Monitoring of these CPPs in situ has typically been limited to just a few of the simplest parameters such as temperature, pressure, pH, and DO because simple one-dimensional sensors exist to measure these properties.
Chemical and biochemical properties, which are more complex to measure, are typically measured off-line. However, the inherently time consuming nature of off-line analysis makes it unsuitable for the real-time process control called for in the PAT initiative.
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