edoc

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

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.

Full text not available from this repository.

Official URL: http://edoc.unibas.ch/dok/A6411169

Downloads: Statistics Overview

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 > Pharmazeutische Technologie (Huwyler)
UniBasel Contributors:Québatte, Gabriela and Rios, Anacelia and Huwyler, Jörg
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:American Chemical Society
ISSN:0003-2700
Note:Publication type according to Uni Basel Research Database: Journal article
Related URLs:
Identification Number:
Last Modified:04 Sep 2015 14:30
Deposited On:04 Sep 2015 14:30

Repository Staff Only: item control page