The Importance of Particle Characterization in Nanopharmaceuticals

Particle characterization is one of the biggest challenges when creating effective preparations for the nanoscale delivery of therapeutics. Conventional batch analysis techniques typically suffer from trade-offs between detail, simplicity, and sampling efficiency.

Image Credit: Corona Borealis Studio/Shutterstock.com

Field-flow fractionation (FFF) offers a powerful size-based separation technique for analyzing macromolecules and nanoparticles ranging from 1 to 1000 nm in diameter. One of the unique advantages of FFF is its minimal sample preparation requirements. The separation process removes most impurities and automatically performs dialysis into the carrier fluid, streamlining the workflow.

 

When combined with online multi-angle light scattering (MALS) and DLS detectors, FFF provides detailed, quantitative size distributions and structural information while sampling large ensembles for statistically robust results.

The capabilities of FFF-MALS-DLS are particularly valuable for meeting regulatory requirements related to the enhanced characterization of liposomal drug formulations and other nanoparticle delivery systems. These advancements have contributed to the development of global standards for nanoparticle characterization, including ISO TS 21362 and ASTM WK 68060, as well as techniques outlined by the NCI-NCL and EU-NCL.

FFF-MALS-DLS system components and organization

Figure 1. FFF-MALS-DLS system components and organization. The DLS detector is embedded in the MALS detector. Image Credit: Waters | Wyatt Technology

Download the application note to explore the theory, data, and analysis in detail.

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This information has been sourced, reviewed and adapted from materials provided by Waters | Wyatt Technology.

For more information on this source, please visit Waters | Wyatt Technology.

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