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Review
. 2021 Sep:176:113897.
doi: 10.1016/j.addr.2021.113897. Epub 2021 Jul 24.

The importance of nanoparticle physicochemical characterization for immunology research: What we learned and what we still need to understand

Jeffrey D Clogston  1
Affiliations
Review

The importance of nanoparticle physicochemical characterization for immunology research: What we learned and what we still need to understand

Jeffrey D Clogston. Adv Drug Deliv Rev. 2021 Sep.

Abstract

Physicochemical characterization of nanoparticles intended for immunology research is important as it helps explain the observed immunological effects. More importantly, it relates the physicochemical properties with the immunological properties to draw meaningful conclusions. There are many physicochemical parameters, with each having numerous analytical techniques and instrumentation to measure them. Thus, where to begin can be challenging even for the experienced scientist. This paper aims to provide guidance to the immunology scientist on how best to characterize their nanoparticles. A step-by-step guide for the physicochemical characterization of liposomal formulations, based on the FDA's guidance for industry for Liposome Drug Products, is provided. Eight critical quality attributes have been identified and for each, the methodology and the physicochemical questions one should consider are discussed. This chapter also addresses common physicochemical characterization mistakes and concludes with a perspective on the type of measurements needed to address current physicochemical characterization gaps and challenges.

Keywords: Batch-to-batch consistency; Critical quality attributes; Liposome drug products; Nanomedicine; Particle counting; Size/size distribution; Stability.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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