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Discovery & Development Drug Delivery, Formulation

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 2

sponsored by Malvern Panalytical

A Malvern Instruments' Bioscience Development Initiative

Executive Summary

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 its 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.  In this four-part white paper series, common issues and questions surrounding the principles, measurements and analysis of DLS data are discussed in order to help minimize the time required for and complexity of acquiring and interpreting DLS data that is critical throughout the development process.  In this second white paper of the series, we cover the influence of concentration effects and particle interactions on DLS results and provide a roadmap for identifying and distinguishing each type of concentration effect.

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