Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development

Hawe A, Zölls S, Freitag A and Carpenter JF

This chapter gives an overview of methods for the analysis of subvisible 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, and visual inspection. 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 microscopic techniques, 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.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, 1st edition (Houde D and Berkowitz SA, Eds.)…

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