Ensuring product quality is of utmost importance and a thorough characterization of molecules and samples at all steps of the development process is critical for an integrated, QbD-driven approach to process development. Analytics and assay instruments produce huge amounts of complex readout data, often from different laboratories and external CROs, and in diverse formats. These data need to be captured, integrated, processed, and analyzed for the establishment of robust, reproducible analytical tests and to provide analytical support to assess product quality in the context of applied process parameters.
Genedata Bioprocess® enables a fully integrated approach to the analytical characterization of samples across the full large-molecule development workflow. All data is centrally captured, managed, analyzed, and made accessible to all involved parties along the process. Genedata Bioprocess helps to significantly reduce timelines and costs, enabling the characterization of large amounts of samples in the highest quality.