Métodos alternativos ao uso de animais para a detecção de pirogênio: oportunidades e desafios no controle da qualidade de produtos biológicos

The need for alternatives to animal use was guided by the 3R’s principle and culminated in the development and acceptance by European Pharmacopoeia of the in vitro alternative method, the Monocyte Activation Test (MAT, 2.6.30/ 2010). MAT uses as matrix human monocytes sources (whole blood, PBMC, or cell lines) respecting the concept of the 3R’s and excluding inherent risks to inter-species extrapolation. This is a promising and efficient method, which detects broad spectrum of pyrogens and cover limitations of current recommended pharmacopoeial in vitro test the (Bacterial Endotoxin) and the Rabbit Pyrogen Test. Despite the advantages addressed to MAT, some technical-scientifics and regulatories roadblocks may be transposed to its effective implementation in the industrial routine, especially for biological products.