Genedata Bioprocess

Analytical Development & Support

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.

Integrate

Integrates diverse and disparate molecule characterization workflows, by streamlining and harmonizing processes and data coming from different groups (e.g. CLD, USP, DSP, formulation); streamlines and harmonizes all analytics processes and makes the resulting data comparable

Capture

Captures all analytics and assay data of any type (capillary electrophoresis, size-exclusion chromatography, UPLC, MS, particle size measurement, endotoxin quantification, RT PCR, Surface Plasmon Resonance, optical density-based quantification, ELISA, and many more), often produced by different laboratories involved in the characterization of a biomolecule sample, across different sites and teams

Process

Processes and aggregates all assay and analytics data, independent of the used instruments and data formats; associates all characterization data to their respective samples, putting the data into the context of the sample treatment conditions and the molecule’s properties and production history

Interpret

Interprets and analyzes all analytics data, and correlates all data with molecule information, process data, and materials with the relational hierarchy of registered samples to expression constructs, cell lines and host cell lines, unit operations, media and raw materials, as well as experimental protocols 

Report

Reports the impact of process parameters on product yield and quality, as measured by various analytical technologies, so that captured product properties represent all types of key analytical data, such as glycosylation profiles, structural heterogeneity, charge heterogeneity, aggregation, purity, and stability

Enable

Enables an integrated Quality-by-Design (QbD) approach by correlating Critical Product Attributes (CQA) with Critical Process Parameters (CPP); systematically monitors CQAs and predicts potential developability and manufacturability risks as early as possible in the process