Presented at PEGS, Boston, MA, USA
The increasing number of biopharmaceutical development projects, combined with the application of more and more high-throughput technologies in cell line and bioprocess development, has led to a significant increase in the amount of data to be captured, processed, and analyzed. Genedata Bioprocess® is an E2E platform co-developed in close collaboration with leading biopharmaceutical companies that supports the entire bioprocess development workflow. The platform not only fully automates cell line development and assessment of scale-down upstream processes (USP), it also manages USP up-scaling, downstream process (DSP) development, as well as analytical and formulation development. It enables the lineage tracking of all batches, starting from the transfection of a cell line through to the vials containing the final drug substance and drug product. Analytical and process data, together with raw material and equipment details and molecule and cell line information, are related to these batches, enabling the systematic assessment, at any stage, of cell lines, raw materials, processes and molecules - all in one platform. The platform can be applied to antibodies (IgGs, novel bi- and multi-specific formats), as well as to other therapeutic proteins and cell therapeutics (e.g., engineered FVIII variants, fusion proteins, CAR-T). It directly integrates with instruments, such as pipetting robots, bioreactors, control systems, and bioanalyzers. The platform’s query and reporting infrastructure enables integrated, informed decision-making throughout the process development workflow and comprehensive learning across different development campaigns and molecules.