Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Endotoxin masking in human plasma: The role of protein interactions and lipopolysaccharide structure.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2025
Same author

The impact of LPS mutants on endotoxin masking in different detection systems.

Biologicals : journal of the International Association of Biological Standardization·2024
Same author

Effects of Different Container Types on (1→3)-β-D-glucan Recovery.

Molecules (Basel, Switzerland)·2023
Same author

Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation.

PDA journal of pharmaceutical science and technology·2023
Same author

Temperature-Dependent Re-alignment of the Short Multifunctional Peptide BP100 in Membranes Revealed by Solid-State NMR Spectroscopy and Molecular Dynamics Simulations.

Chembiochem : a European journal of chemical biology·2022
Same author

Comparison of pyrogen assays by testing products exhibiting low endotoxin recovery.

ALTEX·2022
Same journal

RETRACTED: Kim et al. The Angiogenesis Inhibitor ALS-L1023 from Lemon-Balm Leaves Attenuates High-Fat Diet-Induced Nonalcoholic Fatty Liver Disease Through Regulating the Visceral Adipose-Tissue Function. <i>Int. J. Mol. Sci.</i> 2017, <i>18</i>, 846.

International journal of molecular sciences·2026
Same journal

Correction: Mahmud et al. Thymoquinone Attenuates NF-κβ Signalling Activation in Retinal Pigment Epithelium Cells Under AMD-Mimicking Conditions. <i>Int. J. Mol. Sci.</i> 2025, <i>26</i>, 11473.

International journal of molecular sciences·2026
Same journal

Correction: Borovikov et al. The Twisting and Untwisting of Actin and Tropomyosin Filaments Are Involved in the Molecular Mechanisms of Muscle Contraction, and Their Disruption Can Result in Muscle Disorders. <i>Int. J. Mol. Sci</i>. 2025, <i>26</i>, 6705.

International journal of molecular sciences·2026
Same journal

Correction: Molagoda et al. Flavonoid Glycosides from <i>Ziziphus jujuba</i> var. <i>inermis</i> (Bunge) Rehder Seeds Inhibit α-Melanocyte-Stimulating Hormone-Mediated Melanogenesis. <i>Int. J. Mol. Sci.</i> 2021, <i>22</i>, 7701.

International journal of molecular sciences·2026
Same journal

Correction: Guo et al. Integrated Transcriptomic and Metabolomic Analysis Reveals the Molecular Regulatory Mechanism of Flavonoid Biosynthesis in Maize Roots Under Lead Stress. <i>Int. J. Mol. Sci.</i> 2024, <i>25</i>, 6050.

International journal of molecular sciences·2026
Same journal

Correction: Chang et al. Improvement of Carbon Tetrachloride-Induced Acute Hepatic Failure by Transplantation of Induced Pluripotent Stem Cells Without Reprogramming Factor c-Myc. <i>Int. J. Mol. Sci.</i> 2012, <i>13</i>, 3598-3617.

International journal of molecular sciences·2026
See all related articles

Related Experiment Video

Updated: Jan 10, 2026

Use of a Monocyte Monolayer Assay to Evaluate Fc&#947; Receptor-mediated Phagocytosis
06:27

Use of a Monocyte Monolayer Assay to Evaluate Fcγ Receptor-mediated Phagocytosis

Published on: January 2, 2017

18.7K

Validation of the Monocyte Activation Test Demonstrating Equivalence to the Rabbit Pyrogen Test.

Luisa Burgmaier1,2, Jonas van den Berg3, Maria Gajewi1

  • 1Microcoat Biotechnologie GmbH, Am Neuland 3, 82347 Bernried am Starnberger See, Germany.

International Journal of Molecular Sciences
|November 27, 2025
PubMed
Summary
This summary is machine-generated.

The Monocyte Activation Test (MAT) offers a superior alternative to the Rabbit Pyrogen Test (RPT) for detecting pyrogens in pharmaceuticals. This study validates the MAT for global regulatory acceptance, replacing the RPT in quality control.

Keywords:
MATMonocyte Activation Testendotoxinnon-endotoxin pyrogenspyrogensvalidation

More Related Videos

Prediction of Red Blood Cell Antibody Significance Using the Monocyte-Macrophage Assay
11:27

Prediction of Red Blood Cell Antibody Significance Using the Monocyte-Macrophage Assay

Published on: February 7, 2025

969
Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

1.0K

Related Experiment Videos

Last Updated: Jan 10, 2026

Use of a Monocyte Monolayer Assay to Evaluate Fc&#947; Receptor-mediated Phagocytosis
06:27

Use of a Monocyte Monolayer Assay to Evaluate Fcγ Receptor-mediated Phagocytosis

Published on: January 2, 2017

18.7K
Prediction of Red Blood Cell Antibody Significance Using the Monocyte-Macrophage Assay
11:27

Prediction of Red Blood Cell Antibody Significance Using the Monocyte-Macrophage Assay

Published on: February 7, 2025

969
Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

1.0K

Area of Science:

  • Pharmacology and Toxicology
  • Biotechnology and Bioassay Development
  • Regulatory Science

Background:

  • The Rabbit Pyrogen Test (RPT) is an in vivo method for pyrogen detection.
  • The Monocyte Activation Test (MAT) is an in vitro alternative detecting endotoxins and non-endotoxin pyrogens (NEPs).
  • Regulatory acceptance of MAT varies between the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP).

Purpose of the Study:

  • To present a two-tiered validation strategy for the Monocyte Activation Test (MAT) applicable to both Ph. Eur. and USP regulatory frameworks.
  • To demonstrate the MAT's suitability as a replacement for the Rabbit Pyrogen Test (RPT) in pharmaceutical quality control.
  • To provide a transferable framework for Good Manufacturing Practice (GMP)-compliant MAT implementation.

Main Methods:

  • A generic, product-independent validation of the MAT was performed according to Ph. Eur., ICH Q2, and USP <1225> guidelines.
  • Key validation parameters included Range and Linearity, Limit of Detection, Accuracy, Specificity, Precision, and Robustness.
  • Robustness testing involved variations in stimulation time, IL-6 read-out timing, freeze-thaw stability, and lot-to-lot comparability. An equivalency study comparing RPT and MAT was also conducted.

Main Results:

  • The generic validation successfully addressed all required parameters, including extensive robustness testing.
  • The Monocyte Activation Test (MAT) demonstrated non-inferiority or superiority compared to the Rabbit Pyrogen Test (RPT).
  • The MAT met requirements for FDA approval as an alternative pyrogen testing method and was successfully applied to parenteral drug products.

Conclusions:

  • The presented two-tiered validation strategy facilitates GMP-compliant implementation of the MAT.
  • The MAT is a scientifically and ethically superior alternative to the RPT for pyrogen testing.
  • This work supports broader international acceptance of the MAT as a replacement for the RPT in pharmaceutical quality control.