Ríos Quiroz, Anacelia and Québatte, Gabriela and Stump, Fabian and Finkler, Christof and Huwyler, Joerg and Schmidt, Roland and Mahler, Hanns-Christian and Koulov, Atanas V. and Adler, Michael. (2015) Measuring Subvisible Particles in Protein Formulations Using a Modified Light Obscuration Sensor with Improved Detection Capabilities. Analytical chemistry, Vol. 87, H. 12. pp. 6119-6124.
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Official URL: http://edoc.unibas.ch/dok/A6411169
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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.
Faculties and Departments: | 05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler) |
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UniBasel Contributors: | Québatte, Gabriela and Rios, Anacelia and Huwyler, Jörg |
Item Type: | Article, refereed |
Article Subtype: | Research Article |
Publisher: | American Chemical Society |
ISSN: | 0003-2700 |
Note: | Publication type according to Uni Basel Research Database: Journal article |
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Identification Number: |
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Last Modified: | 04 Sep 2015 14:30 |
Deposited On: | 04 Sep 2015 14:30 |
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