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In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
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Estimating Vaccine Potency Using Antibody-Based Competition Assays.

Jennifer Doering1, Greta Van Slyke1, Oreola Donini2

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Methods in Molecular Biology (Clifton, N.J.)
|December 16, 2021
PubMed
Summary

A new in vitro assay, RiCoE, assesses vaccine potency without animal studies. This method enhances vaccine stability monitoring for biodefense stockpiles, potentially reducing costs and improving readiness.

Keywords:
Antibody: manufacturingMousePreclinicalRicin toxin subunit vaccineVaccine

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Area of Science:

  • Biodefense
  • Vaccinology
  • Immunology

Background:

  • Vaccine potency and stability are critical for biodefense readiness.
  • Stockpiled vaccines require reliable, long-term stability monitoring.
  • Current methods often rely on costly and time-consuming animal studies.

Purpose of the Study:

  • To describe an in vitro assay for assessing vaccine potency.
  • To provide a method for monitoring stability of stockpiled vaccines.
  • To reduce reliance on animal studies for vaccine potency determination.

Main Methods:

  • Development of a monoclonal antibody-based competition ELISA named RiCoE.
  • Application of RiCoE to assess ricin toxin subunit vaccine potency.
  • Adaptation of the assay for drug substance and drug products with aluminum salt adjuvants.

Main Results:

  • RiCoE provides a reliable in vitro method for vaccine potency assessment.
  • The assay is specific for ricin toxin but adaptable to other vaccine types.
  • Methodology is suitable for subunit and virus-like particle vaccines.

Conclusions:

  • RiCoE offers a viable alternative to animal studies for vaccine potency testing.
  • This in vitro assay can improve the monitoring of vaccine stability in stockpiles.
  • The RiCoE methodology has broad applicability for various vaccine types, enhancing biodefense preparedness.