963 lines
80 KiB
Text
963 lines
80 KiB
Text
<!DOCTYPE html>
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<html lang="en" dir="ltr" prefix="content: http://purl.org/rss/1.0/modules/content/ dc: http://purl.org/dc/terms/ foaf: http://xmlns.com/foaf/0.1/ og: http://ogp.me/ns# rdfs: http://www.w3.org/2000/01/rdf-schema# schema: http://schema.org/ sioc: http://rdfs.org/sioc/ns# sioct: http://rdfs.org/sioc/types# skos: http://www.w3.org/2004/02/skos/core# xsd: http://www.w3.org/2001/XMLSchema# ">
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<h1 class="nist-page__title">An interlaboratory comparison of sizing and counting of subvisible particles mimicking protein aggregates</h1>
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<div class="nist-field__label">Published</div>
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<div class="nist-field__item"><time datetime="2014-11-24T12:00:00Z">November 24, 2014</time>
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<h3 class="nist-field__label">Author(s)</h3>
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<div class="nist-field__item"><span class="nist-author">Dean C. Ripple</span>, <span class="nist-author">Christopher B. Montgomery</span>, Zhishang Hu</div>
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<div class="text-with-summary">
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<h3>Abstract</h3>
|
||
Accurate counting and sizing of protein particles has been limited by discrepancies of counts obtained by different methods. To understand the bias and repeatability of techniques in common use in the biopharmaceutical community, the National Institute of Standards and Technology has conducted an interlaboratory comparison for sizing and counting subvisible particles from 1 to 25 μm. Twenty-three laboratories from industry, government, and academic institutions participated. The circulated samples consisted of a polydisperse suspension of abraded ethylene tetrafluoroethylene particles, which closely mimic the optical contrast and morphology of protein particles. For restricted data sets, agreement between data sets was reasonably good: relative standard deviations (RSDs) of approximately 25% for light obscuration counts with lower diameter limits from 1 to 5 μm, and approximately 30% for flow imaging with specified manufacturer and instrument setting. RSDs of the reported counts for unrestricted data sets were approximately 50% for both light obscuration and flow imaging. Differences between instrument manufacturers were not statistically significant for light obscuration but were significant for flow imaging. We also report a method for accounting for differences in the reported diameter for flow imaging and electrical sensing zone techniques; the method worked well for diameters greater than 15 μm.
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<div class="nist-field__item">Journal of Pharmaceutical Sciences</div>
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<div class="nist-field__label">Volume</div>
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<div class="nist-field__item">104</div>
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<h3 class="nist-field__label">Keywords</h3>
|
||
<div class="nist-field__item">protein particle, protein aggregation, light obscuration, electrical sensing zone, flow imaging, flow microscopy</div>
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<article class="bibcite-reference">
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|
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Ripple, D.
|
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, Montgomery, C.
|
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and Hu, Z.
|
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|
||
(2014),
|
||
An interlaboratory comparison of sizing and counting of subvisible particles mimicking protein aggregates, Journal of Pharmaceutical Sciences, [online], https://doi.org/10.1002/jps.24287
|
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(Accessed March 4, 2025)
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Created November 24, 2014, Updated November 10, 2018
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