UltraScan GMP Software for Biopharma to unlock the power of Analytical Ultracentrifugation

Challenge

  • Analytical ultracentrifugation (AUC) is approaching validation for Good Manufacturing Practices (GMP) due to recent instrumentation advances.
  • AUC validation in a GMP setting demands strict compliance, including the development and validation of GMP-adherent software.
  • This compliance encompasses instrument hardware documentation, data management, software for data acquisition/analysis, process control, audit trails, and automation, with the latest Optima AUC by Beckman Coulter addressing some of these needs.
  • Data acquisition and analysis are disconnected, necessitating manual data transfers and risking data integrity.
  • Analysis relies on unverified, closed-source freeware, making audits unfeasible and consistent results uncertain.
  • Key parameters affecting analysis aren't consistently checked, and there's no assurance of identical corrections.
  • Reports are manually processed and based on subjective interpretations from a non-transparent analysis system.

Solution

  • UltraScan leverages the Optima‚Äôs acquisition system optimized for GMP to directly communicate with the instrument eliminating the need for manual data transfer.
  • UltraScan GMP streamlines the analytical ultracentrifuge's operation, offering fully automated workflow from data acquisition to reporting based on pre-programmed read-only protocols without compromising adaptability.
  • UltraScan offers role-based user management (operator, reviewer, approver, and SME) that can manager, review and approve AUC GMP runs. It also supports E-signatures and audit trails which are visible throughout the report
  • The 'autoflow' supervisor oversees the workflow, tracking each step for multiple Optimas, while remote computers can monitor or initiate experiments as needed.

Conclusion

  • Embracing advances like the UltraScan GMP software can significantly enhance the AUC process which solidfies AUC as the golden standard for solution-based biophysical chracterization and enables new applications for AUC such as quality control in the manufacturing of injectable drugs, vaccines and biologicals .
  • By addressing key challenges like manual data transfer, inconsistent results, and subjective report generation, UltraScan paves the way for efficient, consistent, and GMP-compliant AUC operations. This positions AUC closer to full GMP validation, streamlining the entire process from start to finish.
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