DOSY-NMR yielded an averaged diffusion coefficient among fast exchanging insulin oligomers, ranging between dimer and hexamer in size. However, different diffusion coefficients were observed for five insulin drug products measured using the two methods. Here, DLS and DOSY-NMR methods are shown to be orthogonal and yield identical diffusion coefficient results for a homogenous monomeric protein standard, ribonuclease A. However, little is known about their use and sensitivity as analytical tools for particle size measurement of formulated protein therapeutics. The non-invasive methods of dynamic light scattering (DLS) and Diffusion Ordered SpectroscopY (DOSY) NMR can be used to measure diffusion coefficient and derive the corresponding hydrodynamic radius. ![]() ![]() Particle size distribution, a measurable physicochemical quantity, is a critical quality attribute of drug products that needs to be controlled in drug manufacturing.
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