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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

ABSTRACT: 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 paper describes an interlaboratory comparison with the goal of assessing the measurement variability for 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 main findings included high variability between datasets from different laboratories, with coefficients of variation from 13 % to 189 %. Intralaboratory variability was, on average, 37 % of the interlaboratory variability for an 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 size-coverage range for that class. The study shows that a polydisperse sample can be used to assess performance capabilities of an instrument set-up (including hardware, software, and user settings) and provides guidance for the development of polydisperse reference materials.

SUBMITTER: Benkstein KD

PROVIDER: S-EPMC9912188 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

Benkstein Kurt D KD Balakrishnan Gurusamy G Bhirde Ashwinkumar A Chalus Pascal P Das Tapan K TK Do Ngoc N Duewer David L DL Filonov Nazar N Cheong Fook Chiong FC Garidel Patrick P Gill Nicole S NS Grabarek Adam D AD Grier David G DG Hadley Judith J Hollingsworth Andrew D AD Howard Wesley W WW Jarzębski Maciej M Jiskoot Wim W Kar Sambit R SR Kestens Vikram V Khasa Harshit H Kim Yoen Joo YJ Koulov Atanas A Matter Anja A Philips Laura A LA Probst Christine C Ramaye Yannic Y Randolph Theodore W TW Ripple Dean C DC Romeijn Stefan S Saggu Miguel M Schleinzer Franziska F Snell Jared R JR Tatarkiewicz Jan Kuba JK Wright Heather Anne HA Yang Dennis T DT

Journal of pharmaceutical sciences 20211120 3

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 paper describes an interlaboratory comparison with the goal of assessing the measurement variability for 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 laboratori ...[more]

PMID: 34808214

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Dataset Information

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

Publications

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion.

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