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bioRxiv · 10.1101/2023.10.12.562024

BASIS: BioAnalysis SEDFIT Integrated Software for cGMP Analysis of SV-AUC Data

Yarawsky, A. E.·Gough, E. S.·Zai-Rose, V.·Figueroa, N.·Cunningham, H. M.·Burgner, J. W.·Delion, M. T.·Paul, L. N.
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Abstract

Sedimentation 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-associate 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.

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Yarawsky, A. E., Gough, E. S., Zai-Rose, V., Figueroa, N., Cunningham, H. M., Burgner, J. W., Delion, M. T., Paul, L. N.. 2023-10-12. BASIS: BioAnalysis SEDFIT Integrated Software for cGMP Analysis of SV-AUC Data. https://doi.org/10.1101/2023.10.12.562024

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