Presented at the Bioprocessing Summit, Boston, MA, USA
Fragmented development activities, combined with the increasing application of high throughput technologies, make it challenging for biopharmaceutical companies to keep up with the rapid pace of the highly competitive biotherapeutics market. The increase in the amount of data to be processed and interpreted has also become a major bottleneck. However, the development of safe, effective, and life-saving therapeutics relies on data-driven decisions. Therefore, new automation solutions unifying data stored in silos and streamlining processes and applications are needed to accelerate the development of manufacturing processes. We have co-developed an innovative platform in close collaboration with leading biopharmaceutical companies that supports the entire bioprocess development workflow. Genedata Bioprocess® is an E2E platform that centrally integrates data from post-discovery all the way through transfer to manufacturing. It is tailored to large-molecule therapeutics and provides full traceability of all cell lines, batches, and other materials, together with analytics data. It directly integrates with existing IT infrastructures and other scientific data management systems and laboratory instruments. We show concrete use cases illustrating the ability to search and track all development candidate molecules, expression constructs, cell line lineage, upstream and downstream batches, samples, and analytical test results within one integrated system. All types of novel biotherapeutics - protein and cell therapeutics - can be managed. We show how the system automatically captures output data (online, at-line & offline) from various equipment. Finally, we demonstrate that a systematic assessment of cell lines, raw materials, processes, and molecules can be performed at any process development stage, leading to a significant increase in operational efficiency and throughput.