

Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (2): 213-218.
DOI: 10.19803/j.1672-8629.20250672
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WU Hao1, HE Qing2△, CAI Tong2, PEI Yusheng2, LIU Tao3, WANG Dongmei1,*
Received:2025-09-19
Online:2026-02-15
Published:2026-02-13
CLC Number:
WU Hao, HE Qing, CAI Tong, PEI Yusheng, LIU Tao, WANG Dongmei. Research Progress in Applications of MAT[J]. Chinese Journal of Pharmacovigilance, 2026, 23(2): 213-218.
| [1] KELLUM JA, RONCO C.The Role of Endotoxin in Septic Shock[J]. Critical Care, 2023, 27(1): 400. [2] NASO F, CALAFIORE AM, GAUDINO M, et al.Polyphenols Could Be Effective in Exerting a Disinfectant-Like Action on Bioprosthetic Heart Valves, Counteracting Bacterial Adhesiveness[J]. Cardiology and Cardiovascular Medicine, 2022, 6(5): 487-492. [3] JAVED A, SLINGERLAND CJ, WOOD TM, et al. Chimeric Peptidomimetic Antibiotic Efficiently Neutralizes Lipopolysaccharides (LPS) andBacteria-Induced Activation of RAW Macrophages[J]. Acs Infectious Diseases, 2023, 10, 9(3): 518-526. [4] THURMAN TL, LAHTI CJ, MATEFFY JM, et al.Comparison of Pyrogen Assays by Testing Products Exhibiting Low Endotoxin Recovery[J]. Altex-Alternatives to Animal Experimentation, 2023, 40(1): 117-124. [5] VIPOND C, SUTHERLAND J, NORDGREN K, et al.Development and Validation of a Monocyte Activation Test for the Control/Safety Testing of an OMV-Based Meningococcal B Vaccine[J]. Vaccine, 2019, 37(29): 3747-3753. [6] MOLENAAR-DE BACKER MWA, DOODEMAN P, REZAI F, et al. In vitro Alternative for Reactogenicity Assessment of Outer Membrane Vesicle Based Vaccines[J]. Scientific Reports, 2023, 13(1): 12675. [7] LIU SH, PEI YS, TAN DJ, et al.Research Progress in Detection Methods of Pyrogen and Bacterial Endotoxin[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 33(22): 2331-2337. [8] PEI YS, CAI T, CHEN C, et al.Study on the Application of Supple-mentary Methods of Bacterial Endotoxin Test in Chinese Pharmacopoe[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2022, 39(6): 822-826. [9] THOMAS H.Pyrogen Testing Revisited on Occasion of the 25th Anniversary of the Whole Blood Monocyte Activation Test[J]. Altex-Alternatives to Animal Experimentation, 2023, 38(1): 3-19. [10] FAUZIYAH, MUSTOPA AZ, FATIMAH, et al. Carcinoscorpius and Tachypleus Lysates Assay for Detecting Endotoxin in Milk and Groundwater: Toward Reducing Reliance on Limulus Amebocyte Lysate[J]. Journal of Microbiological Methods, 2025, 232-234: 107119. [11] U.S. Pharmacopeia. Expert Committee Approves Endotoxin Testing Using Non-Animal Derived Reagents[EB/OL]. (2024-07-24)[2025-10-30]. https://www.usp.org/news/expert-committee-approves-endotoxin-testing-using-non-animal-derived-reagents. [12] LI L, CHENG X, WANG J, et al.Determination for the Bacterial Endotoxin of 11 Recombinant Type Ⅲ Humanized Collagen Solution for Injection by the Recombinant C-Factor Method[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2025, 45(3): 530-536. [13] ABDIN SM, MANSEL F, HASHTCHIN AR, et al.Sensor Macrophages Derived from Human Induced Pluripotent Stem Cells to Assess Pyrogenic Contaminations in Parenteral Drugs[J]. Biofabrication, 2024, 16(3): 035017. [14] HAYASHI K, SANO M, KANAYASU-TOYODA T, et al.Evaluation of the Effect of Cell Freshness on Pyrogen Detection Using a Serum-Free Monocyte-activation Test[J]. Plos One, 2024, 19(12): e0316203. [15] European Pharmacopeia Commission.European Pharmacopoeia[M]. Strasbourg: European Directorate for the Quality of Medicines & HealthCare, 2025. [16] SOLATI S, AARDEN L, ZEERLEDER S, et al.An Improved Monocyte Activation Test Using Cryopreserved Pooled Human Mononuclear Cells[J]. Innate Immunity, 2015, 21(7): 677-684. [17] MOLENAAR-DE BACKER MWA, GITZ E, DIEKER M, et al. Performance of Monocyte activation Test Supplemented with Human Serum Compared to Fetal Bovine Serum[J]. Alternatives to Animal Experimentation, 2021, 38(2): 307-315. [18] SONDHI P, ADENIJI T, LINGDEN D, et al.Advances in Endotoxin Analysis[J]. Advances in Clinical Chemistry, 2024, 118: 1-34. [19] KORYAKINA A, FREY E, BRUEGGER P.Cryopreservation of Human Monocytes for Pharmacopeial Monocyte Activation Test[J]. Journal of Immunological Methods, 2014, 405: 181-191. [20] KAAIJK P, VAN STRAATEN I, VAN DE WATERBEEMD B, et al. Preclinical Safety and Immunogenicity Evaluation of a Nonavalent PorA Native Outer Membrane Vesicle Vaccine against Serogroup B Meningococcal Disease[J]. Vaccine, 2013, 31(7): 1065-1071. [21] TAKTAK YS, SELKIRK S, BRISTOW AF, et al.Assay of Pyrogens by Interleukin-6 Release from Monocytic Cell Lines[J]. Journal of Pharmacy and Pharmacology, 1991, 43(8): 578-582. [22] POOLE S, MISTRY Y, BALL C, et al.A Rapid‘One-plate’in vitro Test for Pyrogens[J]. Journal of Immunological Methods, 2003, 274(1-2): 209-220. [23] PEDERSEN BK, BRUUNSGAARD H, KLOKKER M, et al.Exercise-induced Immunomodulation-Possible Roles of Neuroendocrine and Metabolic Factors[J]. International Journal of Sports Medicine, 1997, 18(Suppl 1): 2-7. [24] CARTMELL T, POOLE S, TURNBULL AV, et al.Circulating Interleukin-6 Mediates the Febrile Response to Localized Inflammation in Rats[J]. Journal of Physiology-London, 2000, 526(Pt 3): 653-661. [25] DINARELLO CA, GATTI S, BARTFAI T.Fever: Links with an Ancient Receptor[J]. Current Biology, 1999, 9(4): R147-R150. [26] National Institute of Environmental Health Sciences. ICCVAM Test Method Evaluation Report: Validation Status of Five in vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products[R/OL]. (2008-03-24)[2025-10-23]. https://ntp.niehs.nih.gov/sites/default/files/iccvam/docs/pyrogen/tmer/pyrotmer2008.pdf. [27] HE Q, GAO H, XU LM, et al.Analysis of IL-6 and IL-1β Release in Cryopreserved Pooled Human Whole Blood Stimulated with Endotoxin[J]. Innate Immunity, 2018, 24(5): 316-322. [28] DE MATTOS KA, NAVEGA ECA, SILVA VF, et al.Applicability of the Monocyte Activation Test (MAT) in the Quality Control of the 17DD Yellow Fever Vaccine[J]. Atla-Alternatives to Laboratory Animals, 2018, 46(1): 23-37. [29] STODDARD MB, PINTO V, KEISER PB, et al.Evaluation of a Whole-Blood Cytokine Release Assay for Use in Measuring Endotoxin Activity of Group B Neisseria Meningitidis Vaccines Made from Lipid a Acylation Mutants[J]. Clinical and Vaccine Immunology, 2010, 17(1): 98-107. [30] STOPPELKAMP S, WÜRCHUM N, STANG K, et al. Speeding up Pyrogenicity Testing: Identification of Suitable Cell Components and Readout Parameters for an Accelerated Monocyte Activation Test (MAT)[J]. Drug Testing and Analysis, 2017, 9(2): 260-273. [31] WUNDERLICH C, SCHUMACHER S, KIETZMANN M.Pyrogen Detection Methods: Comparison of Bovine Whole Blood Assay (bWBA) and Monocyte Activation Test (MAT)[J]. Bmc Pharmacology & Toxicology, 2014, 15: 50. [32] ZERVOS C, ZIMMERMAN TP, WILLIS T, et al.Immunoglobulin G from Single Plasma Donor in Immune Globulin Intravenous Causes False Positive Pyrogen Test[J]. Biologicals, 2019, 59: 12-19. [33] BURGMAIER L, PÖLT S, AVCI-ADALI M, et al. The Impact of LPS Mutants on Endotoxin Masking in Different Detection Systems[J]. Biologicals, 2025, 89: 101808. [34] PEI YS, XU L, CAI T, et al.Low Endotoxin Recovery and Mitigation Strategies[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2025, 22(1): 72-75. [35] SOLATI S, ZHANG T, TIMMAN S.The Monocyte Activation Test Detects Potentiated Cytokine Release Resulting from the Synergistic Effect of Endotoxin and Non-endotoxin Pyrogens[J]. Innate Immunity, 2022, 28(3-4): 130-137. [36] JEON Y, JEON S, LIM JY, et al.Monocyte Activation test (MAT) as an Ethical Alternative to Animal Testing[J]. Bmb Reports, 2025, 58(3): 105-115. [37] CARLIN G, VIITANEN E.In vitro Pyrogenicity of the Diphtheria, Tetanus and Acellular Pertussis Components of a Trivalent Vaccine[J]. Vaccine, 2005, 23(28): 3709-3715. [38] DOROUD D, EFTEKHARI Z, DANESHI M, et al.Development of a Monocyte Activation Test for Evaluating Recombinant Hepatitis B Vaccine: a Novel Approach for Pyrogen Assessment[J]. Iranian Biome-dical Journal, 2024, 28(5-6): 273-281. [39] VALENTINI S, SANTORO G, BAFFETTA F, et al.Monocyte-Activation Test to Reliably Measure the Pyrogenic Content of a Vaccine: An in vitro Pyrogen Test to Overcome in vivo Limitations[J]. Vaccine, 2019, 37(29): 3754-3760. [40] CARSON D, MYHILL S, PALMIERI E, et al.Development of a Monocyte Activation Test as an Alternative to the Rabbit Pyrogen Test for Mono-and Multi-Component Shigella GMMA-Based Vaccines[J]. Microorganisms, 2021, 9(7): 1375. [41] SCHROTTMAIER WC, SALZMANN M, BADRNYA S, et al.Platelets Mediate Serological Memory to Neutralize Viruses in vitro and in vivo[J]. Blood Advances, 2020, 4(16): 3971-3976. [42] DANIELS R, VAN DER ELST W, SO C, et al. Fit for Purpose Testing and Independent GMP Validation of the Monocyte Activation Test[J]. Current Research in Toxicology, 2024, 8: 100206. [43] ZHENG LX, WANG MR, SHEN X, et al.Applicability of Monocyte Activation Test for Pyrogen Detection in Succinylated Gelatin Injection[J]. Current Pharmaceutical Analysis, 2021, 17(4): 503-508. [44] BORTON L, COLEMAN K.Material-mediated Pyrogens in Medical Devices: Myth or Reality?[J]. Altex-Alternatives to Animal Experimen-tation, 2025. [45] CIREFICE G, SCHÜTTE K, SPREITZER I, et al. The Future of Pyrogenicity Testing: Phasing out the Rabbit Pyrogen Test-a Meeting Report[J]. Biologicals, 2023, 84: 101702. [46] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China, Volume Ⅳ(中华人民共和国药典四部)[M]. Beijing: China Medical Science Press, 2025. |
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