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’s 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.
