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Application of Dynamic Light Scattering (DLS) to Protein Therapeutic Formulations: Principles, Measurements and Analysis - 1. Basic Principles

Dynamic light scattering (DLS) is an analytical technique used to measure the
particle size distribution of protein formulations across the oligomer and sub-micron
size ranges of approximately 1 nm to 1 μm. The popularity of DLS within the
biopharmaceutical industry is a consequence of the technique’s wide working size and
extended sample concentration ranges, as well as its low volume requirements. With
that said, the challenge that remains with the application of DLS to protein therapeutic
formulations is centered around data interpretation. This four-part white paper series
examines common issues and questions surrounding the principles, measurements
and analysis of DLS data and discusses how to minimize the time required for and
increase the accuracy of acquiring and interpreting DLS data during the biotherapeutic
development process. Here, in Part One of this series, we provide an overview of the
key principles of DLS: theory, correlation statistics, deconvolution algorithms, and the
intensity to mass transform.