Measuring Subvisible Particles in Protein Formulations Using a Modified Light Obscuration Sensor with Improved Detection Capabilities

Published on Jun 2, 2015in Analytical Chemistry6.785
· DOI :10.1021/ACS.ANALCHEM.5B00688
Anacelia Ríos Quiroz1
Estimated H-index: 1
(University of Basel),
Gabriela Québatte6
Estimated H-index: 6
(University of Basel)
+ 6 AuthorsMichael Adler11
Estimated H-index: 11
Sources
Abstract
Although light obscuration is the “gold standard” for subvisible particle measurements in biopharmaceutical products, the current technology has limitations with respect to the detection of translucent proteinaceous particles and particles of sizes smaller and around 2 μm. Here, we describe the evaluation of a modified light obscuration sensor utilizing a novel measuring mode. Whereas standard light obscuration methodology monitors the height (amplitude) of the signal, the new approach monitors its length (width). Experimental evaluation demonstrated that this new detection mode leads to improved detection of subvisible particles of sizes smaller than 2 μm, reduction of artifacts during measurements especially of low concentrations of translucent protein particles, and higher counting accuracy as compared to flow imaging microscopy and standard light obscuration measurements.
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