A Master Cell Bank (MCB) banking troubleshooting case study: Challenges and process improvements with comprehensive root cause analysis
May 6-11, 2018
Mammalian cells, especially Chinese hamster ovary (CHO) cells, are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Master Cell banking is one of the key step during drug development, which ensures preservation of cells at low temperatures for an extended period of time for GMP drug substance manufacturing. CHO cells can show significant variation in growth characteristics during cell line development. This variation necessitates the need for a robust Master Cell Bank (MCB) manufacturing process to ensure consistent MCB thaw and growth.
Numerous efforts have been done to understand the cryopreservation mechanism as well as techniques to improve the robustness of banking processes. However, failure of MCB releasing still happens across the industry. A case study will be presented highlighting experiments carried out to identify root cause of MCB thaw and expansion variability. In this study, the health of the cells was examined using an Apoptosis assay and Transmission Electron Microscopy (TEM) analysis to gain a better understanding of the cell bank health. Process improvements that included further passaging of the cell line for improved robustness of the MCB manufacturing process will be discussed.
Lianchun Fan, Kathleen Bierilo, Jianlin Xu, Yongqi Wu, John Megill, Mike Borys, Glenn MacIssac, and Anurag Khetan, "A Master Cell Bank (MCB) banking troubleshooting case study: Challenges and process improvements with comprehensive root cause analysis" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/ccexvi/141