Application of a Best Practice Approach Using Resonant Mass Measurement for Biotherapeutic Product Characterization |
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Authors: | Aaron B Krueger Judith Hadley Philip P Cheney Natalia Markova John F Carpenter Amber Haynes Fradkin |
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Institution: | 1. KBI Biopharma, Inc, 2500 Central Avenue, Boulder, Colorado 80301;2. Malvern Panalytical, 117 Flanders Road, Westborough, Massachusetts 01581;3. University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, 12850 East Montview Boulevard, V20-4119, Aurora, Colorado 80045 |
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Abstract: | Characterizing and quantifying subvisible particles in protein drug products is critical to ensuring product quality. A variety of analytical methods are used to detect and make meaningful measurements of subvisible particles. Resonant mass measurement (RMM) is a novel technology that characterizes the subvisible particle content of samples on a particle-by-particle basis. The technology presents great promise in the study of therapeutic protein products. As an emerging tool in the biopharmaceutical field, the best practices and limitations of RMM for protein products have not been well established. One key challenge of particle analysis is producing robust and reliable data, with high precision and accuracy, for particle characterization. In this study, we develop a set of possible best practices for RMM using a model protein system. We test the effects of these practices on the repeatability and reproducibility of particle measurements. Additionally, we present the data collected under a rigorously controlled set of operating conditions at 3 collaborating sites as well as a summary of the resulting optimal practices. In employing these practices, we successfully obtained improved relative standard deviation values and achieved high reproducibility and repeatability in both sizing and concentration measurement results over a broad range of sample volumes. |
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Keywords: | particle size nanoparticle(s) microparticle(s) biopharmaceutical characterization protein aggregation antibody(s) IgG antibody(s) |
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