BASIS: BioAnalysis SEDFIT integrated software for cGMP analysis of SV-AUC data

Area of Science:

• Biophysical characterization
• Analytical chemistry
• Gene and cell therapy manufacturing

Background:

• Sedimentation velocity analytical ultracentrifugation (SV-AUC) is a well-established technique for antibody therapeutic characterization.
• SV-AUC is increasingly adopted in gene and cell therapy for viral vector analysis, particularly for determining capsid loading ratios.
• Historically, SV-AUC has been limited to characterization, not release testing, in cGMP environments.

Purpose of the Study:

• To address the challenges of implementing SV-AUC in a cGMP environment.
• To introduce a novel program for compliant data handling and analysis of SV-AUC data.
• To facilitate the use of SV-AUC for release testing in viral vector manufacturing.

Main Methods:

• Implementation of SV-AUC in a current Good Manufacturing Practice (cGMP) setting.
• Development and utilization of the "BASIS" program for data management.
• Application of the SEDFIT software for SV-AUC data analysis.

Main Results:

• SV-AUC is validated as a "gold standard" for viral vector capsid loading ratio determination.
• The BASIS program provides 21 CFR Part 11-compliant data handling and analysis.
• Challenges in adapting SV-AUC for cGMP release testing were overcome.

Conclusions:

• SV-AUC can be successfully implemented for cGMP-compliant release testing of viral vectors.
• The BASIS program and SEDFIT software support regulatory compliance for SV-AUC data.
• This advancement supports the quality control of gene and cell therapies.