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.