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  • Titill er á ensku Development of mAb production batch fingerprint based on in-line capacitance measurements
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  • Útdráttur er á ensku

    Viable cell density (VCD) is a highly important parameter in mammalian cell cultivations, typically measured offline. In accordance with the process analytical technology (PAT) initiative, which aims to allow for better process understanding and control, there has been a focus on the development of analytical technology allowing real-time monitoring of important culture parameters. Dielectric spectroscopy, or capacitance technology, has gained popularity for in-line monitoring of VCD. This method is based on applying electric fields to the suspension, resulting in live cells becoming polarized. Live cells contribute to the readings, while dead cells and other particles show less of a signal. Here, capacitance probes were included in two different CHO cell processes producing mAb target products in scales ranging from 15 L to 250 L. Batch fingerprints for both processes were developed, which may serve as golden batch trajectories to which future batches are compared. Biomass factor optimization was done for each proces, resulting in a general biomass factor that can be used to convert capacitance readings into VCD measurements in real-time, allowing continuous monitoring of VCD and quick detection of process deviations. Comparisons of capacitance trends across different scales revealed no systematic differences between scales, indicating that the processes were robust and scalable, and that capacitance can be used to reliably monitor VCD during process scale-up. Consistent with the literature, the single-frequency capacitance measurements used here provided highly accurate VCD predictions during the exponential growth phase, but lost accuracy in later stages of the cultivation. Thus, there is an opportunity for further improvement in in-line VCD measurements for these processes, as well as any future processes, which may be achieved using multi-frequency capacitance measurements.

  • 30.5.2023

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