BPI 2022, Vienna
May 17, 2022
Cell line and process development groups increasingly apply miniaturized and automated cell culturing and analytical test methods. This includes micro-bioreactor systems, Process Analytical Techniques (PATs) and multiple methods for early product quality assessment. As a result, there has been a significant increase in the amount of data, which need to be analyzed and reviewed. The data structuring and curation has therefore become a serious bottleneck to proper data analysis and valid decision making. We have designed a highly integrated data management and workflow system, which supports automated workflows and provides the foundation for increasing throughput in cell line and process development. The system is designed to continuously capture, in a highly structured manner, the heterogeneous data during the course of process development campaigns. It supports the entire process - from expression, construct generation via transfection, cell seeding, selection, passaging, and cryo-conservation to cell culture assessment and product quality analytics. Here, we present use cases to demonstrate how the platform supports screening in scale-down models, such as microtiter plates and micro-bioreactors, by capturing, processing, aggregating, and visualizing online and offline data and integrating the data with product quality and molecule data to enable holistic process development for any type of biologics molecule.