Pyrogenicity

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  • References

    1Hartung T. The human whole blood pyrogen test – lessons learned in twenty years. ALTEX. 2015;32(2):79-100.

    2Hartung T. Pyrogen testing revisited on occasion of the 25th anniversary of the whole blood monocyte activation test. ALTEX. 2021;38(1):3-19.

    3Gimenes I, et al. Assessment of pyrogenic response of lipoteichoic acid by the monocyte activation test and the rabbit pyrogen test. Regul Toxicol Pharmacol. 2015;73(1):356-360.

    4Hoffmann S, et al. International validation of novel pyrogen tests based on human monocytoid cells. J Immunol Methods. 2005;298(1-2):161-173.

    5Schindler S, et al. Comparison of the reactivity of human and rabbit blood towards pyrogenic stimuli. ALTEX. 2003;20(2):59-63.

    6Hasiwa N, et al. Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test. ALTEX. 2013;30(2):169-208.

    7Vipond C, et al. Limitations of the rabbit pyrogen test for assessing meningococcal OMV based vaccines. ALTEX. 2016;33(1):47-53.

    8Vipond C, et al. Development and validation of a monocyte activation test for the control/safety testing of an OMV-based meningococcal B vaccine. Vaccine. 2019;37(29):3747-3753.

    9Etna MP, et al. Optimization of the monocyte activation test for evaluating pyrogenicity of tick-borne encephalitis virus vaccine. ALTEX. 2020;37(4):532-544.

    10Mazzotti F, et al. In vitro pyrogen test – a new test method for solid medical devices. J Biomed Mater Res A. 2007;80(2):276-282.

    11Werner L, et al. Detection of pyrogens adsorbed to intraocular lenses: evaluation of limulus amoebocyte lysate and in vitro pyrogen tests. J Cataract Refract Surg. 2009;35(7):1273-1280.

    12Stang K, et al. Highly sensitive pyrogen detection on medical devices by the monocyte activation test. J Mater Sci Mater Med. 2014;25(4):1065-1075.

    13Brown J, et al. Using the monocyte activation test as a stand-alone release test for medical devices. ALTEX. 2021;38(1):151-156.

    14Hasiwa M, et al. An in vitro pyrogen safety test for immune-stimulating components on surfaces. Biomaterials. 2007;28(7):1367-1375.

    15Solati S, et al. An improved monocyte activation test using cryopreserved pooled human mononuclear cells. Innate Immun. 2015;21(7):677-684.

    16Schindler S, et al. International validation of pyrogen tests based on cryopreserved human primary blood cells. J Immunol Methods. 2006;316(1-2):42-51.

    17Daneshian M, et al. Assessment of pyrogenic contaminations with validated human whole-blood assay. Nat Protoc. 2009;4(12):1709-1721.

    18Schindler S, et al. Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood. ALTEX. 2009;26(4):265-277.

    19Hennig U. Implementing the in vitro pyrogen test: one more step toward replacing animal experimentation. Altern Lab Anim. 2013;41(5):P58-60.

    20Koryakina A, et al. Cryopreservation of human monocytes for pharmacopeial monocyte activation test. J Immunol Methods. 2014;405:181-191.

    21ICCVAM. Validation status of five in vitro test methods proposed for assessing potential pyrogenicity of pharmaceuticals and other products. 2008.

    22The European Directorate for the Quality of Medicines & Healthcare. Monocyte-activation test. In 10th ed. European Pharmacopoeia. Council of Europe;2020.

    23European Union Reference Laboratory (EURL) ECVAM. EURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches Publications Office of the European Union;2020.