Presented at the Bioprocessing Summit, August 2018, Boston, MA, USA
Implementation of an Integrated E2E Bioprocess Development Workflow Platform at Celgene
James Daly, Biologics Development, Celgene
Developing large-molecule therapeutics is a challenging and costly task, as diverse and complex R&D activities spanning cell line development, upstream and downstream process development, and scale-up for GMP manufacturing need to be integrated. Here, we present how Celgene, has implemented an enterprise end-to-end (E2E) workflow platform, based on Genedata Bioprocess®, to integrate and streamline development activities, which can support the growing number of biologics programs. The new system acts as a cross-functional data backbone that integrates all bioprocess development workflows from post-discovery through transfer to manufacturing, and will lead to a significant increase in Celgene’s operational efficiency and throughput. It has the capability to capture output data automatically (online, at-line & offline) along the process from various equipment including ViCell, Cedex Bio HT, Biacore, Octet, Cellmetrics, ambr® systems, and Unicorn. Using the fully integrated platform, Celgene is now able to search and track all development candidate molecules, expression constructs, cell line lineage, upstream and downstream batches, samples, and analytical test results. The platform enables transparent access to all relevant bioprocessing data for in-depth statistical analysis and decision making, as well as for systematic comparison of cell lines, unit operations, and entire process development campaigns.