Moving analytical ultracentrifugation software to a good manufacturing practices (GMP) environment

dc.contributor.authorSavelyev, Alexey
dc.contributor.authorGorbet, Gary E.
dc.contributor.authorHenrickson, Amy
dc.contributor.authorDemeler, Borries
dc.descriptionOpen access article. Creative Commons Attribution 4.0 International License (CC BY 4.0) appliesen_US
dc.description.abstractRecent advances in instrumentation have moved analytical ultracentrifugation (AUC) closer to a possible validation in a Good Manufacturing Practices (GMP) environment. In order for AUC to be validated for a GMP environment, stringent requirements need to be satisfied; analysis procedures must be evaluated for consistency and reproducibility, and GMP capable data acquisition software needs to be developed and validated. These requirements extend to multiple regulatory aspects, covering documentation of instrument hardware functionality, data handling and software for data acquisition and data analysis, process control, audit trails and automation. Here we review the requirements for GMP validation of data acquisition software and illustrate software solutions based on UltraScan that address these requirements as far as they relate to the operation and data handling in conjunction with the latest analytical ultracentrifuge, the Optima AUC by Beckman Coulter. The software targets the needs of regulatory agencies, where AUC plays a critical role in the solution-based characterization of biopolymers and macromolecular assemblies. Biopharmaceutical and regulatory agencies rely heavily on this technique for characterizations of pharmaceutical formulations, biosimilars, injectables, nanoparticles, and other soluble therapeutics. Because of its resolving power, AUC is a favorite application, despite the current lack of GMP validation. We believe that recent advances in standards, hardware, and software presented in this work manage to bridge this gap and allow AUC to be routinely used in a GMP environment. AUC has great potential to provide more detailed information, at higher resolution, and with greater confidence than other analytical techniques, and our software satisfies an urgent need for AUC operation in the GMP environment. The software, including documentation, are publicly available for free download from Github. The multi-platform software is licensed by the LGPL v.3 open source license and supports Windows, Mac and Linux platforms. Installation instructions and a mailing list are available from ultrascan.aucsolutions.comen_US
dc.identifier.citationSavelyev, A., Gorbet, G. E., Henrickson, A., & Demeler, B. (2020). Moving analytical ultracentrifugation software to a good manufacturing practices (GMP) environment. PLoS Computational Biology, 16(6): Article e1007942.
dc.publisherPublic Library of Scienceen_US
dc.publisher.departmentDepartment of Chemistry and Biochemistryen_US
dc.publisher.facultyArts and Scienceen_US
dc.publisher.institutionUniversity of Montanaen_US
dc.publisher.institutionAUC Solutionsen_US
dc.publisher.institutionUniversity of Lethbridgeen_US
dc.subjectGood manufacturing practicesen_US
dc.subjectData acquisition software
dc.subjectUltraScan software
dc.subjectOptima AUC
dc.subjectAnalytical ultracentrifugation
dc.titleMoving analytical ultracentrifugation software to a good manufacturing practices (GMP) environmenten_US
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