Presented at The Bioprocessing Summit, Boston, MA, USA
The key aim of cell line development is the provision of stably expressing, high-yield mammalian cell lines for biopharmaceutical production. Recent progress in automation technologies, as well as new Quality-by-Design (QbD) approaches, have resulted in a very significant increase in experimental throughput. This, in turn, has led to a dramatic increase in the number of samples and associated analytics data that need to be processed, analyzed, interpreted, and reported across the whole CMC/Pharmaceutical Development organization. Here, we report on Genedata BioprocessTM, a new workflow platform that enables highly automated, high-throughput cell line development processes, shortening typical cell line development campaigns and significantly reducing overall costs. The platform has been developed over the last four years in close collaboration with leading biopharmaceutical companies. We present concrete use cases showing how our platform supports the entire cell line development workflow including seeding, clone selection, incubation, passaging, analyzing, and cryo-conservation of cells. The system tracks the full history of all clones – from initial transfection all the way to their evaluation in controlled bioreactor environments – and directly integrates all product quality and analytics data. As a fully integrated platform, it directly integrates with all instruments, such as assay readers, pipetting robots, and colony pickers. Finally, the system performs a developability assessment of all molecules and their critical quality attributes (CQAs such as glycosylation, deamination, stability, expressibility). The platform can be applied to both antibodies (IgGs, bispecifics, novel scaffolds) as well as therapeutic proteins (e.g., engineered FVIII variants, fusion proteins).