Alternative methods for the detection of pyrogens in products and environment subject to public health surveillance: advances and perspectives in Brazil based on the international recognition of the Monocyte Activation Test

• Autor(a) principal: da Silva, Cristiane Caldeira
• Data de Publicação: 2018
• Outros Autores: de Oliveira, Carolina Barbara Nogueira, Carneiro, Patrícia dos Santos, Marengo, Eliana Blini, de Mattos, Katherine Antunes, de Almeida, Ricardo Sergio Couto, Spoladore, Janaína, Alves, Gutemberg Gomes, Presgrave, Octavio Augusto França, Delgado, Isabella Fernandes
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1082
• topic: Alternative Methods; Pyrogen; Monocyte Activation Test; In vitro Techniques; Quality Control; Legislation; Métodos Alternativos; Pirogênio; Teste de Ativação de Monócitos; Técnicas in vitro; Controle da Qualidade; Legislação

Introduction: The detection of pyrogens is essential for the quality control of injectable products. The Rabbit Pyrogen Test remains widely used, despite the existence of alternative methods such as the Monocyte Activation Test (MAT). Objective: To review the use of alternative methods for pyrogen testing, pointing out advances and perspectives from the recognition of MAT by the European pharmacopoeia and its acceptance for regulatory purposes in Brazil. Method: A search was performed on the PubMed and BVS databases, with further classification, categorization by topic and critical analysis of the results. Results: Twenty-four papers were identified, addressing topics such as applications of MAT, its validation and comparisons with in vivo tests. MAT presented better results when compared to other tests, both in the evaluation of biological products and in the detection of non-endotoxin pyrogens. Limitations to diffusion include difficulties in obtaining whole human blood as a source of monocytes, for which several alternatives have been proposed. Conclusions: MAT is a promising method, with application in safety evaluation of new technologies. Its application in Brazil depends on a national implementation policy, which might include greater integration between BraCVAM, Concea and RENAMA in search for its recognition for regulatory purposes.