Screening Developability And Pre-Formulation Of Biotherapeutics With High-Throughput Dynamic Light Scattering (HT–DLS)

By Daniel Some, Ph.D., Wyatt Technology Corp.

One of the primary technologies for assessing aggregation, stability and viscosity of biotherapeutics, from proteins and peptides to attenuated viruses, is dynamic light scattering (DLS).1 DLS measures particle size and size distributions, from less than a nanometer and up to several microns, without perturbing the sample.

Traditional DLS measurements take place manually, one at a time, in cuvettes, resulting in low throughput and low productivity. Cuvette-based analysis limits the number of candidates and formulations that can be analyzed, restricting the implementation of highly efficient development strategies such as quality by design (QbD) and Design of Experiments (DoE).

High-throughput dynamic light scattering (HT-DLS) provides more data, on more samples and more formulations—typically 10x – 100x more measurements than would be collected using cuvette-based DLS, but with far less effort.

This white paper introduces the technology that powers automated HT–DLS and explores its practical applications in candidate and formulation selection.