Evaluation of bioanalyzers for upstream commercial manufacturing
May 6-11, 2018
The analyzer currently in use in one of our commercial manufacturing sites for measurement of pH, gases, metabolites and electrolytes during cell culture requires lengthy troubleshooting and excessive maintenance. This has led to loss of operator time and occasional disruption of manufacturing activities. The objective of this study was to replace the current membrane-based analyzer with a more reliable instrument. Two options were evaluated in an effort to reduce maintenance frequency and to minimize operator time spent troubleshooting. Option 1 was to employ a new generation, fully-automated membrane-based analyzer of the same type as the ones currently in place in the manufacturing suite. Option 2 was to employ a combination of a pH/gas analyzer and an absorption/photometric-based metabolite/electrolyte analyzer. Comparability between options 1 and 2 and the analyzer currently in use at the manufacturing site was assessed in the laboratory using quality control standards and bioreactor samples from several commercial cell culture processes. Additionally, operational reliability and robustness of each option relative to the current analyzer as well as fit of the proposed analyzer options with other analyzers in place in commercial BMS facilities were taken into consideration. A summary of the advantages and pitfalls of each option to substitute the current analyzer in the context of a commercial manufacturing facility will be provided.
Pani Apostolidis, Brandon Raghobir, Tim Diehl, Eddie Crabbe, Ron Bates, and Ninad Patil, "Evaluation of bioanalyzers for upstream commercial manufacturing" 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). https://dc.engconfintl.org/ccexvi/98