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Atomically Traceable Nanostructure Fabrication

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Process Analytical Strategies for Size Monitoring: Offline, At-Line, Online, and Inline Methods in a Top-Down

Christina Glader¹, Ramona Jeitler², Yan Wang³

¹Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.

|June 27, 2025

Summary

This summary is machine-generated.

This study shows how Dynamic Light Scattering (DLS) and spatially resolved DLS (SR-DLS) can be used as Process Analytical Technology (PAT) tools for real-time nanoparticle size monitoring in continuous manufacturing.

Keywords:

PAT tools continuous top-down manufacturing dynamic light scattering lipid-based nanosystems real-time size monitoring spatially resolved dynamic light scattering

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Area of Science:

Pharmaceutical Technology
Nanotechnology
Process Engineering

Background:

Continuous manufacturing is crucial for nanopharmaceuticals, demanding integrated Process Analytical Technology (PAT) for quality control.
Real-time monitoring of critical quality attributes like particle size is essential but challenging for nanosystems.
Dynamic Light Scattering (DLS) and spatially resolved DLS (SR-DLS) are explored as PAT tools.

Purpose of the Study:

To evaluate the applicability of DLS and SR-DLS as PAT tools in a continuous nanopharmaceutical production line.
To assess key factors affecting DLS and SR-DLS measurements for various lipid-based nanosystems.
To demonstrate the benefits of integrating different DLS measurement modes for process control.

Main Methods:

Utilized conventional DLS (Litesizer 500) and SR-DLS (NanoFlowSizer) in offline, at-line, inline, and online modes.
Investigated solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC), and nanoemulsions (NEs).
Systematically assessed effects of dilution, viscosity, measurement angle, and temperature on measurement reliability.

Main Results:

Offline screening confirmed that proper sample dilution is critical for reliable DLS measurements.
At-line DLS enabled efficient final product quality control with reduced manual input.
Inline and online SR-DLS provided real-time particle size tracking, reducing waste and enabling immediate process adjustments.

Conclusions:

Integrating offline, at-line, inline, and online DLS techniques offers comprehensive monitoring throughout the nanopharmaceutical production line.
This integrated approach streamlines processes, allows for real-time adjustments, and ensures reliable quality control.
The study validates DLS and SR-DLS as effective PAT tools for continuous nanopharmaceutical manufacturing.