Chapter 10 – Submicrometer, micrometer and visible particle analysis in biopharmaceutical research and development

Hawe, Andrea, Daniel Weinbuch, Sarah Zölls, Angelika Reichel, and John F. Carpenter. "Submicrometer, micrometer and visible particle analysis in biopharmaceutical research and development." In Biophysical Characterization of Proteins in Developing Biopharmaceuticals, pp. 285-310. Elsevier, 2020.

Abstract
This chapter gives an overview of methods for the analysis of submicrometer, micrometer and visible particles within biopharmaceutical products: dynamic light scattering, nanoparticle tracking analysis, asymmetrical flow field flow fractionation, resonant mass measurements, electrical sensing zone method, light obscuration, flow microscopy, visual inspection and microscopic techniques. For each method the underlying measurement principle and readout parameters are outlined, followed by a discussion of its relevance for a pharmaceutical development, recommendations on when to use the method and for which analytical questions. For other less frequently used methods, i.e., flow cytometry or taylor dispersion analysis a brief overview is given. The chapter is concluded by general recommendations on particle analysis, including sample preparation issues, the role of the formulation and strategies for method selection.

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Keywords
Coulter counterDynamic light scatteringElectric sensing zone methodField flow fractionationFlow microscopyLight obscurationNanoparticle tracking analysisResonant mass measurementsSubvisible particlesVisible particlesVisual inspection

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