{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T18:36:15Z","timestamp":1793298975143,"version":"4.5.0"},"reference-count":61,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T00:00:00Z","timestamp":1541030400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Altern Lab Anim"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:p>The meningococcal C conjugate vaccine (MenCC) is an interesting model with which to test the efficacy of the Monocyte Activation Test (MAT) as an alternative method of pyrogen testing in the quality control of vaccines. The MenCC that has been produced by Bio-Manguinhos in Brazil is in the final development stage, and, as recommended in the guidelines for MenCC production, its pyrogen content must be determined by using the Limulus Amoebocyte Lysate (LAL) assay and the Rabbit Pyrogen Test (RPT). This represents an ideal opportunity to compare LAL and RPT data with data obtained by using a MAT system with cryopreserved whole blood and IL-6\/IL-1\u03b2 as marker readouts. In order to assess the compatibility of the MAT with MenCC, endotoxin and non-endotoxin pyrogen content was quantified by using MenCC samples spiked with lipopolysaccharide (LPS), lipoteichoic acid or zymosan standards. The presence of the aluminium-based adjuvant interfered with the MAT, increasing the readout of IL-1\u03b2 in LPS-spiked MenCC batches. This infringed the product-specific validation criteria of the test, and led to IL-6 being chosen as the more suitable marker readout. No pyrogenic contaminants were identified in the MenCC batches tested, demonstrating consistency among the different systems (MAT, RPT and the LAL assay). In conclusion, the introduction of the MAT during MenCC development could contribute to the elimination of animal tests post-licensing, ensuring human protection based on an effective non-animal based method of quality control.<\/jats:p>","DOI":"10.1177\/026119291804600506","type":"journal-article","created":{"date-parts":[[2019,4,9]],"date-time":"2019-04-09T04:40:05Z","timestamp":1554784805000},"page":"255-272","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["A Comparison of Pyrogen Detection Tests in the Quality Control of Meningococcal Conjugate Vaccines: The Applicability of the Monocyte Activation Test"],"prefix":"10.1177","volume":"46","author":[{"given":"Vitor Fernandes","family":"Silva","sequence":"first","affiliation":[{"name":"Departamento de Controle de Qualidade, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"da Silva Guedes Junior","sequence":"additional","affiliation":[{"name":"Departamento de Controle de Qualidade, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivna Alana","family":"da Silveira","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia Bacteriana, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra Santos","family":"Almeida","sequence":"additional","affiliation":[{"name":"Departamento de Controle de Qualidade, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"de Paiva Conte","sequence":"additional","affiliation":[{"name":"Laborat\u00f3rio de Tecnologia de Anticorpos Monoclonais, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabella Fernandes","family":"Delgado","sequence":"additional","affiliation":[{"name":"Departamento de Farmacologia e Toxicologia, Instituto Nacional de Controle da Qualidade em Sa\u00fade, Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiane Caldeira","family":"Silva","sequence":"additional","affiliation":[{"name":"Departamento de Farmacologia e Toxicologia, Instituto Nacional de Controle da Qualidade em Sa\u00fade, Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Octavio Augusto Fran\u00e7a","family":"Presgrave","sequence":"additional","affiliation":[{"name":"Departamento de Farmacologia e Toxicologia, Instituto Nacional de Controle da Qualidade em Sa\u00fade, Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine Antunes","family":"de Mattos","sequence":"additional","affiliation":[{"name":"Departamento de Controle de Qualidade, Instituto de Tecnologia em Imunobiol\u00f3gicos (Bio-Manguinhos), Funda\u00e7\u00e3o Oswaldo Cruz, Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,11,1]]},"reference":[{"key":"bibr1-026119291804600506","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200105033441807"},{"key":"bibr2-026119291804600506","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.018544"},{"key":"bibr3-026119291804600506","doi-asserted-by":"publisher","DOI":"10.1080\/14760584.2017.1258308"},{"key":"bibr4-026119291804600506","unstructured":"Minist\u00e9rio da Sa\u00fade (2017). 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