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An interlaboratory comparison on the characterization of a sub-micrometer polydisperse particle dispersion

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The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This study describes an interlaboratory comparison on the characterization of a sub-micrometer polydisperse particle dispersion composed of five sub-populations of poly(methyl methacrylate) (PMMA) and silica beads. The study included 20 participating laboratories from industry, academia, and government, and a variety of state-of-the-art particle-counting instruments. The received datasets were organized by instrument class to enable comparison of intralaboratory and interlaboratory performance. The results showed high variability between datasets from different laboratories, with coefficients of variation from ≈ 13 % up to 189 %. Intralaboratory variability was, on average, ≈ 37 % of the interlaboratory variability for a given instrument class and particle sub-population. Drop-offs at either end of the size range and poor agreement on maximum counts of particle sub-populations were noted. The mean distributions from an instrument class, however, showed the full size-coverage range for that type of instrument. The study shows that a poly-disperse sample can be used to assess performance capabilities of a given instrument set-up (including hardware, software, and user settings) and provides guidance for the development of polydisperse reference materials.
2022-03-15
ELSEVIER SCIENCE INC
JRC125205
0022-3549 (online),   
https://doi.org/10.1016/j.xphs.2021.11.006,    https://publications.jrc.ec.europa.eu/repository/handle/JRC125205,   
10.1016/j.xphs.2021.11.006 (online),   
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