@article{6f1615c41248430ab2c3cbd9f36d49e8,
title = "Best Practices for Aggregate Quantitation of Antibody Therapeutics by Sedimentation Velocity Analytical Ultracentrifugation",
abstract = "Analytical ultracentrifugation (AUC) is a critical analytical tool supporting the development and manufacture of protein therapeutics. AUC is routinely used as an assay orthogonal to size exclusion chromatography for aggregate quantitation. This article distills the experimental and analysis procedures used by the authors for sedimentation velocity AUC into a series of best-practices considerations. The goal of this distillation is to help harmonize aggregate quantitation approaches across the biopharmaceutical industry. We review key considerations for sample and instrument suitability, experimental design, and data analysis best practices and conversely, highlight potential pitfalls to accurate aggregate analysis. Our goal is to provide experienced users benchmarks against which they can standardize their analyses and to provide guidance for new AUC analysts that will aid them to become proficient in this fundamental technique.",
keywords = "Analytical ultracentrifugation, Antibody drug(s), Antibody(s), Biopharmaceutical characterization, HPLC (high performance/pressure liquid chromatography, Monoclonal antibody(s), Protein aggregation",
author = "Bou-Assaf, {George M.} and Budyak, {Ivan L.} and Michael Brenowitz and Day, {Eric S.} and David Hayes and John Hill and Ranajoy Majumdar and Paola Ringhieri and Peter Schuck and Lin, {Jasper C.}",
note = "Funding Information: This work was supported by the Intramural Research Programs of the National Institute of Biomedical Imaging and Bioengineering, NIH. The authors of this article are volunteer members of the Biophysics Working Group assembled under the auspices of CASSS – Sharing Science Solutions, 5900 Hollis Street, Suite R3, Emeryville, CA 94608. The authors thank Barth{\'e}lemy Demeule (Genentech), Robert Kelley (Genentech), and Brandon L. Doyle (Eli Lilly and Company) for their insightful suggestions while authoring this manuscript. Michael R. De Felippis (Eli Lilly and Company) is thanked for critically reviewing the manuscript. Funding Information: This work was supported by the Intramural Research Programs of the National Institute of Biomedical Imaging and Bioengineering, NIH . The authors of this article are volunteer members of the Biophysics Working Group assembled under the auspices of CASSS – Sharing Science Solutions, 5900 Hollis Street, Suite R3, Emeryville, CA 94608. The authors thank Barth{\'e}lemy Demeule (Genentech), Robert Kelley (Genentech), and Brandon L. Doyle (Eli Lilly and Company) for their insightful suggestions while authoring this manuscript. Michael R. De Felippis (Eli Lilly and Company) is thanked for critically reviewing the manuscript. Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = jul,
doi = "10.1016/j.xphs.2021.12.023",
language = "English (US)",
volume = "111",
pages = "2121--2133",
journal = "Journal of Pharmaceutical Sciences",
issn = "0022-3549",
publisher = "John Wiley and Sons Inc.",
number = "7",
}