May 8-13, 2016
Dissolved carbon dioxide (dCO2) or partial pressure of carbon dioxide (pCO2) is an important process parameter that may impact process performance (product titer and viability) and product quality attributes (such as glycosylation) during mammalian cell culture process in a bioreactor. The impact of altered level of pCO2 on the cell culture process may manifest itself upon process scale-up if the CO2 removal rate is not consistent between the development scale and the manufacturing scale. The pCO2 level during cell culture process is normally determined through offline measurement; however, the offset between online and offline pCO2 may conceal the true effect of pCO2 on the cell culture process. In this presentation, several studies using online pCO2 monitoring will be summarized and discussed, including 1) implementation of online pCO2 probe for measurement of actual pCO2 levels in a large scale bioreactor, 2) comparison of online and offline pCO2, 3) correlation between pH and pCO2, 4) estimation of CO2 stripping rate in large scale bioreactors, and 5) effect of sample handling on pCO2 level measurement. The key findings in this presentation are intended to establish biopharmaceutical manufacturing process knowledge, which is valuable for all partners in the cell culture manufacturing network.
Ting Kuo Huang, Jacob Mauger, and James Dvornicky, "Application of online CO2 monitoring to enable a better understanding of cell culture performance variation between GMP-scale and scaled-down bioreactors" in "Cell Culture Engineering XV", Robert Kiss, Genentech Sarah Harcum, Clemson University Jeff Chalmers, Ohio State University Eds, ECI Symposium Series, (2016). http://dc.engconfintl.org/cellculture_xv/140