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European Biopharmaceutical Review

Simply Good Monitoring




Process development aims at fast and efficient designs of new processes or optimising existing ones. Modern development environments use highly automated systems to perform the basic tasks of measurement, monitoring, and control. Additionally, increasing digitisation enables storage, processing, and application of data and model-based methods in real time. Hence, efficiency can be significantly increased in process development, which ultimately leads to a speed-up to market and guarantees process stability over the product lifecycle. Focusing on biopharmaceutical process development, there are still highly manual workflows; for example, the production of a substance mixture (media and buffer), the processing and analysis of samples (draw, prepare, analyse, store), and the generation of process reports. In the present case study, it is shown how the combination of automation and digitisation can accelerate process development, with respect to the processing and analysis of samples. Liquid samples are still the most important source of process-relevant data. For example, in upstream processing, almost all information regarding substrates, biomass, byproducts, and the product itself is based on samples and their analysis.

Typically, the process of sampling and analysis is performed in a separate analytical laboratory, resulting in a time offset. Such at-line or even off-line samples are not suitable for timely feedback and control. To close this gap, firstly, the sampling, the sample processing, and the analysis must be automated. Secondly, the generated data must be digitised to enable feedback and control in time. With the example of an industrial cell culture process, it will be demonstrated how a robust product monitoring of monoclonal antibodies (mAb) can be implemented and used for control. The basis for this is:

    1. A liquid handling system (Numera, Securecell AG), which draws and processes samples from the bioreactor
    2. A standard high-performance liquid chromatography HPLC for the analysis (UltiMate 3000TM, Thermo Fisher Scientific)
    3. A bioprocess software (Lucullus PIMS, Securecell AG) to control all devices and manage the data: this combination results in an integrated PAT solution, as shown in Figure 1

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Paul Kroll studied process engineering at the TU Dresden, Germany. Early on, he worked on model-based methods for monitoring and controlling bioprocesses. Paul received his doctorate in this field at the Vienna University of Technology, Austria, and later became a postdoc for model-based methods and digital twins. Since 2018, he has worked as a Business Development Manager for the Process and Information Management System, Lucullus PIMS, at Securecell AG.

Alexandra Hofer studied pharmacy at the University of Vienna, Austria, and subsequently did her doctorate in the Faculty of Technical Chemistry at the Vienna University of Technology. In particular, she dealt with analytical methods used for process monitoring in biopharmacy. Since 2018, she has worked as a Business Development Manager for the automated sampling system, Numera, at Securecell AG.
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Paul Kroll
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Alexandra Hofer
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