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

Eur Biophys J. 2024 Feb 8. doi: 10.1007/s00249-024-01700-4. Online ahead of print.ABSTRACTSedimentation velocity analytical ultracentrifugation (SV-AUC) has long been an important method for characterization of antibody therapeutics. Recently, SV-AUC has experienced a wave of new interest and usage from the gene and cell therapy industry, where SV-AUC has proven itself to be the "gold standard" analytical approach for determining capsid loading ratios for adeno-associated virus (AAV) and other viral vectors. While other more common approaches have existed in the realm of cGMP-compliant techniques for years, SV-AUC has long been used strictly for characterization, but not for release testing. This manuscript describes the challenges faced in bringing SV-AUC to a cGMP environment and describes a new program, "BASIS", which allows for 21 CFR Part 11-compliant data handling and data analysis using the well-known and frequently cited SEDFIT analysis software.PMID:38329496 | DOI:10.1007/s00249-024-01700-4
Source: European Biophysics Journal : EBJ - Category: Physics Authors: Source Type: research