Assessment of Tunable Resistive Pulse Sensing (TRPS) Technology for Particle Size Distribution in Vaccine...

Area of Science:

• Nanotechnology
• Biotechnology
• Analytical Chemistry

Background:

• Accurate particle sizing is crucial for vaccine formulation development and quality control.
• Conventional dynamic light scattering (DLS) offers ensemble-based measurements but can face limitations with polydisperse samples.
• Emerging technologies like tunable resistive pulse sensing (TRPS) provide particle-by-particle analysis, offering potential advantages in resolution and accuracy.

Purpose of the Study:

• To comparatively assess particle sizing capabilities of DLS and TRPS for vaccine formulations.
• To identify limitations of each technique, including instrument variability, sensitivity, and resolution in mixed populations.
• To evaluate three distinct vaccine formulations as case studies.

Main Methods:

• Simultaneous evaluation of three in-house vaccine formulations (protein antigen, outer membrane vesicle, viral particles).
• Utilized TRPS-based Exoid and two DLS instruments (Zetatrac, Zetasizer).
• Assessed particle size distribution, aggregates, and resolution of polydisperse species.

Main Results:

• DLS may overestimate particle size and average results in polydisperse samples; TRPS addresses this but has size range limitations.
• Significant differences in sensitivity were observed between two DLS instruments.
• TRPS demonstrated superior resolution of large aggregate species in polydisperse vaccine samples compared to DLS.

Conclusions:

• TRPS serves as a valuable orthogonal technique to conventional DLS for precise vaccine characterization.
• Both DLS and TRPS are effective for size characterization, yielding comparable results.
• The optimal technique choice depends on the specific vaccine formulation and the size range of interest.