Genedata Bioprocess

Product & Quality Module

Genedata Bioprocess® integrates and aggregates all product quality data and process outcomes acquired along biologics development workflows. The data is automatically associated to samples and key process parameters describing the generation of the corresponding samples. The system allows users to systematically assess the impact of process parameters on product yield and quality, as measured by various analytical technologies. As a result, the captured product properties represent all types of key analytical data, such as glycosylation profile, structural heterogeneity, charge heterogeneity, aggregation, purity, and stability.

Supported Analytical Technologies

  • Mass spectrometry (MS)
  • Chromatography (SEC, HIC, IEX, RP, AC; HPLC, UPLC)
  • (Capillary) electrophoresis (SDS, IEF)
  • Dynamic light scattering and (DLS)
  • Differential scanning calorimetry (DSC)
  • Surface plasmon resonance (SPR)
  • Biolayer interferometry techniques (BLI)
  • Reverse transcription PCR
  • ELISA plate reader systems

Genedata Bioprocess forms the foundation for the comprehensive and systematic assessment of developability and manufacturability of large-molecule drug candidates at each step prior to and during process development. Report views of analytical data include intuitive color-coding of the outcome of analytical tests, which indicate whether or not the results meet the developability criteria.

The system enables all groups in cell line, process, and formulation development to consider product analytical data in their experiments, which makes a more holistic process development approach possible.

Genedata Bioprocess makes upstream and downstream process development significantly more efficient by providing a fully integrated sample lineage and analytical data tracking infrastructure, including full documentation of all applied protocols. Data sets from different unit operations can easily be compared in order to optimize, characterize, or validate process steps. Similarly, data sets from every step of a developed manufacturing processes can be quickly accessed and visualized for deeper analysis. The system also provides interfaces for integration with statistical analysis software packages (e.g., for Design of Experiments approaches).

To facilitate the underlying laboratory logistics, Genedata Bioprocess comes with a full-fledged sample management system. All samples, such as expression or purification batches, are registered and assigned unique IDs before undergoing subsequent testing. All aliquots are centrally registered, including the physical location and the distribution status of each sample. The system supports both low-throughput manual, as well as high-throughput fully automated and barcoded sample management processes. Comprehensive Certificate-of-Analysis (CoA) documents and other reports are auto-generated and can be produced at any point in the workflow.

The open system architecture allows for simple yet flexible integration with various analytics instruments to address customer-specific integration requirements.