Current methods for determining cell growth, using offline viable cell count instruments, are variable and prone to error.  Developing secondary methods for density measurements can improve process robustness, reduce variability, streamline manufacturing operations and potentially improve process performance.  A survey of available in-line technologies for cell growth such as capacitance probes and dissolve oxygen output were evaluated. In contrast to cell counts, which are measured offline typically once per day, Dissolved oxygen (DO) output presents a simple and efficient way to monitor cell growth real time.  A retrospective data analysis of commercial-scale data showed strong correlation between DO output and cell density.  Implementation of this technology provides opportunities for robust process controls in addition to a reduction in frequency of samples for offline measurements.  This poster will present the results of this evaluation and current implementation activities.

Just breathe: Examining sparge rates to improve robustness in cell culture density measurements in commercial biologics manufacturing

243rd National Meeting (2012)

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