Rabies Vaccine Characterization by Nanoparticle Tracking Analysis.

Area of Science:

• Biopharmaceutical characterization
• Vaccine formulation analysis
• Nanotechnology applications in medicine

Background:

• Biopharmaceutical formulation consistency is crucial for vaccine effectiveness.
• Particle size, concentration, and shape variations can compromise vaccine performance.
• A simple, reliable method for monitoring these particle characteristics is needed.

Purpose of the Study:

• To characterize particle concentration and size distribution of a rabies vaccine (RABV) using Nanoparticle Tracking Analysis (NTA).
• To qualify the NTA technique for RABV particle characterization by assessing thermal stability and antigenicity.
• To compare NTA results with traditional methods like ELISA for antigenicity assessment.

Main Methods:

• Nanoparticle Tracking Analysis (NTA) was employed to measure particle concentration and size distribution.
• Vaccine stability was assessed across a temperature range of 5-55°C.
• Enzyme-Linked Immunosorbent Assay (ELISA) and NTA were used to monitor antigenicity.

Main Results:

• RABV particles exhibited a size range of 100-250 nm (mean 150 nm), consistent with antigenic virus-like particles.
• Thermal stress at 55°C led to a decrease in labelled particle concentration after 144 hours, indicating loss of G protein antigenicity without aggregation.
• NTA and ELISA showed good correlation in assessing RABV antigenicity over 24 months of stability monitoring.

Conclusions:

• NTA is a suitable and reliable method for characterizing biopharmaceutical suspensions like RABV.
• The technique provides valuable insights into particle characteristics, stability, and antigenicity.
• NTA can contribute to ensuring the consistency and effectiveness of biopharmaceutical formulations.