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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.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics