Abstract
Nanoparticle tracking analysis (NTA) is a relatively new technique for the size characterization of particles between 40 and 1000 nm. Recent studies have shown an increasing interest in NTA as a complementary technique in the field of pharmaceutical sciences. In this review, the applications of NTA for the characterization of biopharmaceuticals are discussed, and procedures are proposed for the determination of size distributions. The size distribution of monoclonal antibody (mAb) aggregates in samples produced from different clones in the presence of cell culture medium is presented as an example in addition to that of seasonal influenza vaccines. This review also discusses techniques such as fluorescence microscopy with Nile Red staining, micro-flow imaging, 90° light scattering, and flow field-flow fractionation (FFF) and concludes that NTA is a suitable technique for a wide range of applications in the field of biopharmaceuticals.
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