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Updated: Jan 20, 2026

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Shape Characterization of Subvisible Particles Using Dynamic Imaging Analysis.

Roman Mathaes1, Mark Cornell Manning2, Gerhard Winter1

  • 1Pharmaceutical Technology, Ludwig-Maximilian Universitaet, Munich, Germany.

Journal of Pharmaceutical Sciences
|September 3, 2019
PubMed
Summary
This summary is machine-generated.

Dynamic imaging analysis struggles to accurately characterize the shape of subvisible particles (SbvP) below 5 μm. New nonspherical particle standards reveal limitations in microflow imaging and FlowCAM systems for protein drug products.

Keywords:
bioanalysisimage analysisparticle sizeprotein aggregationprotein formulation(s)

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Biotechnology

Background:

  • Subvisible particles (SbvP) are common in protein drug products and are under scrutiny by regulatory agencies.
  • Dynamic imaging analysis (DIA) is a technique used to visualize and understand SbvP, with United States Pharmacopeia <1787> suggesting its use for morphology measurements (4-100 μm).
  • A lack of commercially available nonspherical particle standards hinders accurate morphology characterization within the suggested DIA size range.

Purpose of the Study:

  • To fabricate a well-defined nonspherical particle standard for evaluating DIA systems.
  • To assess the capability of microflow imaging (MFI) and FlowCAM systems to characterize SbvP shape (2-10 μm).
  • To compare the accuracy of DIA systems against scanning electron microscopy (SEM) for particle morphology.

Main Methods:

  • Fabrication of a homogenous, well-defined nonspherical particle standard.
  • Utilizing scanning electron microscopy (SEM) to determine the actual aspect ratio of particles.
  • Employing two DIA systems, MFI and FlowCAM, to characterize particle shape in the 2-10 μm range.
  • Developing a test procedure to evaluate the accuracy of DIA in determining particle shape characteristics.

Main Results:

  • DIA systems demonstrated reduced accuracy in morphology characterization for particles sized 5 μm and 2 μm.
  • Scanning electron microscopy (SEM) provided a benchmark for actual particle aspect ratios.
  • The study successfully compared and evaluated differences between the MFI and FlowCAM systems.
  • The developed test procedure proved effective in assessing the accuracy of DIA for nonspherical particles.

Conclusions:

  • Current DIA systems exhibit limitations in accurately characterizing the morphology of smaller nonspherical subvisible particles (SbvP).
  • The study highlights the need for defined operational ranges for DIA systems in SbvP analysis.
  • The developed nonspherical particle standard and test procedure are valuable tools for validating DIA performance in pharmaceutical applications.