Presented at Bio-IT World, Boston, MA, USA
The discovery and development of large-molecule therapeutics is fundamentally different from the small-molecule, chemical R&D process. The design, production, and testing of innovative biopharmaceuticals produces huge volumes of complex data that need to be captured, structured, integrated, processed, analyzed, and interpreted. The management of such data generated along the biologics R&D process is one of the key bottlenecks in large-molecule R&D. Here, we present the Genedata Biopharma Platform, an enterprise software system that supports the entire biologics R&D process. The platform not only supports large-molecule screening and engineering, but also cell line development and bioprocess development, which includes expression, purification, and analytics. It simplifies and streamlines laborious, manual processes such as cloning and analytics data interpretation, resulting in increased efficiency, throughput, and improved quality of drug candidates due to reduction of ad hoc and error-prone sample and data handling. This out-of-the box solution scales with hundreds of users and is an open system that can be easily integrated in any corporate IT landscape. We present concrete use cases with a special focus on automating and integrating workflows for MS-based biopharmaceutical characterization, NGS-based cell line characterization and validation, and highly specialized screening processes such as SPR. The Genedata Biopharma Platform has been developed over the last 20 years, in close collaboration with leading biopharma R&D organizations, and has been adopted by a majority of the leading biopharmaceutical companies around the world.