Characterization and control of culture media and buffer preparation processes: Closing the gap
May 6-11, 2018
As supporting processes, culture media and buffer preparation add little direct value to the biopharmaceutical bulk drug substance manufacturing process. However, these necessary unit operations represent an inordinate amount of risk to an overall process both in terms of potential for contamination (Fletcher and Harris, 2016) and potential for introducing variability. For these reasons, media and buffer preparation represent an untapped opportunity for optimization and reducing risk. Closing this gap would mean eliminating one of the last remaining weak links in the vision of building a closed manufacturing process.
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Wayne Mauro and Thomas Fletcher, "Characterization and control of culture media and buffer preparation processes: Closing the gap" 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/24