Presented at BPI Europe, Vienna, Austria
Cell line and process development groups apply more and more miniaturized and automated cell culturing and analytical test methods. These include micro-bioreactor systems, Process Analytical Techniques (PATs) and several methods for early assessment of product quality. As a consequence, the amount of data which needs to be analyzed and reviewed, has grown significantly. Thus, data structuring and curation represents 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 an increase in 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 whole 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 concrete use cases demonstrating 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 them with product quality and molecule data to enable holistic process development for any type of biologics molecule.