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Advancing Pyrogen Testing for Vaccines with Inherent Pyrogenicity: Development of a Novel Reporter Cell-Based

Sijia Yi1, Jenny Xu1, Liping Song2

  • 1Analytical Research and Development, Merck & Co., Inc., West Point, PA 19486, USA.

Vaccines
|October 28, 2025
PubMed
Summary

A novel reporter cell-based monocyte activation test (MAT) offers a reliable alternative to traditional pyrogen testing. This assay ensures pharmaceutical safety by accurately detecting pyrogens, supporting animal testing reduction.

Keywords:
3Rsmonocyte activation test (MAT)outer membrane protein complex (OMPC)pyrogenicityreporter cell linevaccine safety

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Area of Science:

  • Pharmaceutical safety and quality control
  • In vitro diagnostics and assay development
  • Immunology and innate immune responses

Background:

  • Pyrogens are critical quality attributes for pharmaceutical safety, detected by Toll-like receptors (TLRs) on monocytes.
  • The traditional rabbit pyrogen test (RPT) exhibits significant variability and inaccuracy, especially for complex vaccines.
  • Existing in vitro alternatives face challenges with donor variability and operational complexity.

Purpose of the Study:

  • To develop a reliable reporter cell-based monocyte activation test (MAT) for pyrogen detection.
  • To provide a quality control method supporting the 3Rs initiative (Refinement, Reduction, Replacement) in animal testing.
  • To establish a robust assay suitable for pharmaceutical release testing.

Main Methods:

  • Screening of human monocytic reporter cell lines with NFκB-responsive elements and luminescent reporters.
  • Quantification of luminescence following stimulation with various endotoxin and non-endotoxin pyrogens.
  • Validation of a THP-1-derived reporter cell MAT for outer membrane protein complex (OMPC) using linearity, accuracy, precision, and robustness parameters.

Main Results:

  • THP-1 reporter cells effectively detected a broad spectrum of pyrogens using simple luminescence readouts.
  • The MAT demonstrated excellent linearity (R² ≥ 0.99), accuracy (bias within ±10.3%), and precision (%RSD ≤ 6.9%) for OMPC testing.
  • The assay exhibited robustness, with minimal impact from deliberate variations in assay parameters, suitable for routine release.

Conclusions:

  • Reporter cell-based MAT assays improve consistency, reliability, and efficiency in pyrogenicity and safety evaluations.
  • These assays support global efforts to reduce animal testing while maintaining regulatory compliance.
  • Implementation of MAT enhances the quality control of pharmaceutical products.