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Off and On: Advances in Nanoparticle and Protein Electrophoretic Mobility Measurements by MP-PALS in Batch and Online Modes
Aug 03 2015
Author: Steven Trainoff PhD, Daniel Some PhD on behalf of Wyatt Technology Corporation
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Nanoparticle formulations are ubiquitous throughout modern pharmaceutical development; from protein biotherapeutics and vaccine adjuvants through to virus-like particles and emerging novel drug delivery systems. However, developing these complex formulations and suspensions is a challenging process. Proteins and nanoparticles are often unstable in suspension, with aggregation a particularly pressing concern. Unchecked aggregation can reduce the bioavailability of a nanotherapeutic or, for proteins, even induce a dangerous immunogenic response in the patient. Developing a stable formulation is therefore critical to meeting performance, safety and commercial targets.
Characterisation of the net molecular charge of proteins in solution is a key component in optimising formulation stability. Likewise, the zeta potential of nanoparticles is an essential predictor of stability. While conventional techniques for determining electrophoretic mobility (and hence net molecular charge or zeta potential) are generally able to analyse electrophoretic mobility of nanoparticles reliably in many formulations, they may fail under certain conditions such high-salt buffers, and are prone to damaging the sample when measuring proteins or other biomacromolecules. Massively Parallel Phase Analysis Light Scattering (MP-PALS) overcomes these challenges to provide reliable, reproducible and nondestructive electrophoretic mobility measurements of fragile biomolecules and other particles in practically all formulation buffers.
This article explores the technological advantages of MP-PALS and its role across bio/nanopharmaceutical development. Case studies illustrate how automated MP-PALS enables rapid, high throughout analysis of electrophoretic mobility and particle size in formulation. Fluorescent particles that are usually unsuited to standard zeta potential analysis are readily characterised by MP-PALS. Data are also presented on new investigations into online coupling of MP-PALS with Size Exclusion Chromatography (SEC). This novel technique performs electrophoretic mobility measurements in real-time as samples are eluted from the SEC column, providing mobility measurements across the entire size distribution...
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