Show simple item record Savelyev, Alexey Gorbet, Gary E. Henrickson, Amy Demeler, Borries 2021-06-24T01:24:20Z 2021-06-24T01:24:20Z 2020
dc.identifier.citation Savelyev, 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. en_US
dc.description Open access article. Creative Commons Attribution 4.0 International License (CC BY 4.0) applies en_US
dc.description.abstract Recent 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 en_US
dc.language.iso en_US en_US
dc.publisher Public Library of Science en_US
dc.subject Good manufacturing practices en_US
dc.subject Data acquisition software
dc.subject UltraScan software
dc.subject Optima AUC
dc.subject Analytical ultracentrifugation
dc.subject.lcsh Ultracentrifugation
dc.subject.lcsh Centrifuges
dc.title Moving analytical ultracentrifugation software to a good manufacturing practices (GMP) environment en_US
dc.type Article en_US
dc.publisher.faculty Arts and Science en_US
dc.publisher.department Department of Chemistry and Biochemistry en_US
dc.description.peer-review Yes en_US
dc.publisher.institution University of Montana en_US
dc.publisher.institution AUC Solutions en_US
dc.publisher.institution University of Lethbridge en_US
dc.publisher.url en_US

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