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1. Brazilian National Network of Alternative Methods (RENAMA) 10th Anniversary: Meeting of the Associated Laboratories, May 2022

Author

Ivan de Ávila, Renato, primary, Fentem, Julia, additional, Villela, Izabel, additional, Somlo, Debora, additional, Fusco Almeida, Ana Marisa, additional, Mendes-Giannini, Maria José S., additional, Di Pietro Micali Canavez, Andrezza, additional, Bosquetti, Bruna, additional, Catarino, Carolina Motter, additional, Schuck, Desiree Cigaran, additional, Valadares, Bruna Nardy, additional, Facchini, Gustavo, additional, Marigliani, Bianca, additional, Migliorini Figueira, Ana Carolina, additional, Hickson, Rosângela, additional, Leme, Daniela Morais, additional, Tagliati, Carlos, additional, de Souza, Larissa C.R., additional, Maria Engler, Silvya Stuchi, additional, Gaspar Cordeiro, Lorena Rigo, additional, Koepp, Janice, additional, Granjeiro, Jose Mauro, additional, de Mello Brandao, Humberto, additional, Munk, Michele, additional, Antunes de Mattos, Katherine, additional, Pedralli, Bruna, additional, Siqueira Furtuoso Rodrigues, Marcella Miranda, additional, Stival, Ana Clara, additional, Andrade, Jordana, additional, Brito, Lara Barroso, additional, Marques dos Santos, Thais Rosa, additional, Leite, Jacqueline, additional, Garcia da Silva, Artur Christian, additional, and Valadares, Marize Campos, additional

Published
2023
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2. Brazilian National Network of Alternative Methods (RENAMA) 10th Anniversary: Meeting of the Associated Laboratories, May 2022

Author

Ivan de Ávila, Renato, Fentem, Julia, Villela, Izabel, Somlo, Debora, Fusco Almeida, Ana Marisa, Mendes-Giannini, Maria José S., Di Pietro Micali Canavez, Andrezza, Bosquetti, Bruna, Catarino, Carolina Motter, Schuck, Desiree Cigaran, Valadares, Bruna Nardy, Facchini, Gustavo, Marigliani, Bianca, Migliorini Figueira, Ana Carolina, Hickson, Rosângela, Leme, Daniela Morais, Tagliati, Carlos, de Souza, Larissa C.R., Maria Engler, Silvya Stuchi, Gaspar Cordeiro, Lorena Rigo, Koepp, Janice, Granjeiro, Jose Mauro, de Mello Brandao, Humberto, Munk, Michele, Antunes de Mattos, Katherine, Pedralli, Bruna, Siqueira Furtuoso Rodrigues, Marcella Miranda, Stival, Ana Clara, Andrade, Jordana, Brito, Lara Barroso, Marques dos Santos, Thais Rosa, Leite, Jacqueline, Garcia da Silva, Artur Christian, and Valadares, Marize Campos

Abstract

The Brazilian National Network of Alternative Methods (RENAMA), which is linked to the Ministry of Science, Technology and Innovation, is currently comprised of 51 laboratories from CROs, academia, industry and government. RENAMA’s aim is to develop and validate new approach methodologies (NAMs), as well as train researchers and disseminate information on their use — thus reducing Brazilian, and consequently Latin American, dependence on external technology. Moreover, it promotes the adoption of NAMs by educators and trained researchers, as well as the implementation of good laboratory practice (GLP) and the use of certified products. The RENAMA network started its activities in 2012, and was originally comprised of three central laboratories — the National Institute of Metrology, Quality and Technology (INMETRO); the National Institute of Quality Control in Health (INCQS); and the National Brazilian Biosciences Laboratory (LNBio) — and ten associated laboratories. In 2022, RENAMA celebrated its 10th anniversary, a milestone commemorated by the organisation of a meeting attended by different stakeholders, including the RENAMA-associated laboratories, academia, non-governmental organisations and industry. Ninety-six participants attended the meeting, held on 26 May 2022 in Balneário Camboriú, SC, Brazil, as part of the programme of the XXIII Brazilian Congress of Toxicology 2022. Significant moments of the RENAMA were remembered, and new goals and discussion themes were established. The lectures highlighted recent innovations in the toxicological sciences that have translated into the assessment of consumer product safety through the use of human-relevant NAMs instead of the use of existing animal-based approaches. The challenges and opportunities in accepting such practices for regulatory purposes were also presented and discussed.

Published
2024
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3. A comparison of pyrogen detection tests in the quality control of meningococcal conjugate vaccines: The applicability of the Monocyte Activation Test.

Author

Fernandes Silva V, da Silva Guedes Junior D, da Silveira IA, Santos Almeida A, de Paiva Conte F, Fernandes Delgado I, Caldeira Silva C, França Presgrave OA, and Antunes de Mattos K

Subjects
Animal Testing Alternatives, Animals, Blood, Cryopreservation, Horseshoe Crabs, Humans, Interleukin-1beta, Interleukin-6, Quality Control, Rabbits, Biological Assay methods, Meningococcal Vaccines chemistry, Monocytes drug effects, Pyrogens chemistry
Abstract

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-1β 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-1β 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., (2018 FRAME.)

Published
2018
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