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

Autor: Yarawsky AE; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Gough ES; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Zai-Rose V; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Figueroa NI; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Cunningham HM; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Burgner JW 2nd; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., DeLion MT; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA., Paul LN; BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA. lpaul@bioanalysisllc.com.
Jazyk: angličtina
Zdroj: European biophysics journal : EBJ [Eur Biophys J] 2024 Apr; Vol. 53 (3), pp. 111-121. Date of Electronic Publication: 2024 Feb 08.
DOI: 10.1007/s00249-024-01700-4
Abstrakt: 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-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.
(© 2024. European Biophysical Societies' Association.)
Databáze: MEDLINE
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