Presented at the Bioprocessing Summit, Boston, MA, USA
Despite the race to bring new biotherapeutics into clinical trials, the cell line development process requires much manual work and is often associated with long development timelines and high costs. There is a great need for a workflow-based data integration solution to increase experimental throughput and to support complex, multi-stage cell line development for any type of novel biotherapeutic modality in order to more efficiently address unmet clinical needs. We have developed a new end-to-end platform called Genedata Bioprocess® for bioprocess development of all types of novel biotherapeutics: IgGs, novel bi- and multi-specific formats, fusion proteins, new scaffolds and cell therapeutics, such as CAR-T cells. The system supports all steps in the cell line development workflow including seeding, selection, passaging, analyzing, cryo-conservation and processing in micro-bioreactors, such as ambr®. It tracks manual or fully-automated cell pool and clone selection, as well as cell maintenance workflows in plates and shake flasks. The system tracks the full history of all clones - from initial transfection all the way to evaluation in bioreactor runs - and combines this information with molecule, product quality, and clone analytics data. It directly integrates with all instruments (liquid handling systems, measurement devices, and bioreactors). Here, we present a full cell line development campaign data set compiled using this platform and highlight clone selection decisions and clone history reporting capabilities. We will show how the platform streamlines generation and assessment of mammalian production cell lines.