Abstract
Mammalian cell culture processes were characterized upon the analysis of the exhaust-gas composition achieved through the on-line integration of a magnetic sector MS analyser with benchtop bioreactors. The non-invasive configuration of the magnetic sector MS provided continuous evaluation of the bioreactor's exhaust gas filter integrity and facilitated the accurate quantification of O2 and CO2 levels in the off-gas stream which ensured preserved bioreactor sterility prior to cell inoculation and provided evidence of the ongoing cellular respiratory activity throughout the cultures. Real-time determination of process parameters such as the Respiratory Quotient (RQ) allowed for precise pin-pointing of the occurrence of shifts in cellular metabolism which were correlated to depletion of key nutrients in the growth medium, demonstrating the suitability of this technology for tracking cell culture process performance.
Highlights
The complexity of mammalian cell culture processes for biopharmaceutical manufacturing has resulted in the rapid development of Process Analytical Technology (PAT) tools aimed at improving batch-to-batch reproducibility through the implementation of real-time process monitoring techniques.[1,2,3]
Contamination events result in considerable productivity losses for biopharmaceutical companies as affected batches become essentially unusable
Unjusti ed variations in medium pH and % dO2 measurements are considered to be the standard approach for establishing the presence of bacterial contaminants[31] analysis of the exhaust gas can be effective for detecting the presence of undesired respiratory activity while being minimally invasive
Summary
Real-time characterization of mammalian cell culture bioprocesses by magnetic sector MS†. Mammalian cell culture processes were characterized upon the analysis of the exhaust-gas composition achieved through the on-line integration of a magnetic sector MS analyser with benchtop bioreactors. The non-invasive configuration of the magnetic sector MS provided continuous evaluation of the bioreactor's exhaust gas filter integrity and facilitated the accurate quantification of O2 and CO2 levels in the off-gas stream which ensured preserved bioreactor sterility prior to cell inoculation and provided evidence of the ongoing cellular respiratory activity throughout the cultures. Real-time determination of process parameters such as the Respiratory Quotient (RQ) allowed for precise pin-pointing of the occurrence of shifts in cellular metabolism which were correlated to depletion of key nutrients in the growth medium, demonstrating the suitability of this technology for tracking cell culture process performance
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