Nanopharmaceuticals and nanoparticle-based vaccines are of increasing importance in the pharmaceutical industry. This trend is illustrated by the leading vaccine candidates against SARS-COV2, in which mRNA delivery is mediated by a lipid nanoparticle, as well as by liposomal formulations of numerous small-molecule drugs.

Nanopharmaceuticals and nano-vaccines pose many characterization challenges during product development as well as in final quality control. Size distribution, drug loading efficiency, drug dose as a function of size, and stability in serum are critical attributes for which suitable high-resolution assays are not readily available or for which multiple complex assays must be employed. MD-AF4 shows great promise for the characterization and lot release of nanopharmaceuticals by providing detailed information in one simple, robust procedure [1,2]. Recent technical advancements that streamline and enhance MD-AF4, making it operator-independent and appropriate for use by QC technicians as well as R&D scientists, include a new level of instrument automation, auto-diagnostic functions and intelligent user guidance. Additional improvements increase the concentration seen by the detectors without injecting more sample, and eliminate mechanical and thermal instabilities, thereby enhancing data quality and repeatability. By increasing ease-of-use and robustness, MD-AF4 becomes a viable option for both characterization and QC of nanopharmaceuticals

1) Yingwen Hu, Rachael M. Crist. Jeffrey D. Clogston, The utility of asymmetric flow field-flow fractionation for preclinical characterization of nanomedicines, Analytical and Bioanalytical Chemistry https://doi.org/10.1007/s00216...

2) Caputo, F., et al. (2020), "Asymmetric-flow field-flow fractionation for measuring particle size, drug loading and (in)stability of nanopharmaceuticals. The joint view of European Union Nanomedicine Characterization Laboratory and National Cancer Institute - Nanotechnology Characterization Laboratory." J Chromatogr A 1635: 461767; https://doi.org/10.1016/j.chro...

Lindsey East

Wyatt Technology Corporation

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