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In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
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Rabies Vaccine Characterization by Nanoparticle Tracking Analysis.

M E Navarro Sanchez1, D Soulet2, E Bonnet2

  • 1Analytical Research & Development, Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Merieux, 69280, Marcy l'Etoile, France. erika.navarrosanchez@sanofi.com.

Scientific Reports
|May 20, 2020
PubMed
Summary

Nanoparticle tracking analysis (NTA) effectively characterizes rabies vaccine (RABV) particle size and concentration. This method correlates well with ELISA for antigenicity, ensuring vaccine consistency and stability.

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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.