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Novel Image-Based Titration Method for Potency Testing of Diphtheria Toxoid in a Vero Cell Assay.

Miyuki Kimura1, Masaaki Iwaki1,2, Tsuyoshi Kenri1

  • 1Department of Bacteriology II, Laboratory Animal and Pathogen Bank, National Institute of Infectious Diseases, JIHS, Japan.

Japanese Journal of Infectious Diseases
|August 31, 2025
PubMed
Summary

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A new cell image analysis method offers an objective and convenient alternative for determining diphtheria toxoid vaccine potency. This approach yields results comparable to traditional methods, improving the efficiency of vaccine quality control.

Area of Science:

  • Immunology
  • Vaccinology
  • Cell Biology

Background:

  • Diphtheria toxoid potency is traditionally assessed using the Vero cell assay, relying on cell metabolism or morphology.
  • Current methods are time-consuming and subjective, posing challenges for efficient vaccine quality control.

Purpose of the Study:

  • To develop and validate a novel, objective, and convenient method for determining diphtheria toxoid potency using cell image analysis.
  • To compare the efficacy of cell image analysis with existing methods for potency determination.

Main Methods:

  • Developed a cell image analysis technique for endpoint determination in the Vero cell assay.
  • Assessed the feasibility and accuracy of image analysis by comparing it with microscopic observation and cell metabolism measurements.
Keywords:
Vero cell assaydiphtheria toxoidendpoint determinationimage analysispotency test

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  • Evaluated the method's performance on commercial diphtheria vaccines.

    • Main Results:

    • Cell image analysis demonstrated effectiveness as an endpoint determination method.
    • Potency values obtained through image analysis were comparable to those from traditional cell metabolism and microscopic observation methods.
    • The image analysis method proved to be objective and convenient.

    Conclusions:

    • Cell image analysis is a reliable alternative for diphtheria vaccine potency testing.
    • This novel method enhances objectivity and convenience in vaccine quality control processes.
    • The findings support the adoption of image analysis for routine diphtheria toxoid potency determination.