Aplicação de métodos alternativos ao uso de animais no desenvolvimento e controle da qualidade de produtos imunobiológicos no Brasil

Abstract

Over recent decades, the use of animals in the scientific environment has been under criticism by various segments of society that question the animal suffering. In the pursuit of an approach that reduces, refines and replaces the use of animals, emerge alternative methodologies based on the 3R's concept. Thus, in this work, analysis and discussions about the subject are gathered from Official Public Laboratories (OPL), producing immunobiological (vaccines and immunesera), mapping the in vivo tests used in the development and quality control, and verifying the applicability of alternative methods. The research in this work was developed by collecting information from the OPLs and consisted of two stages: a questionnaire of sorting, that was received and answered through an electronic platform and by interview, at the OPLfacility, with audio recording. The OPLs show their peculiarities in relation to their realities, such as infrastructure, personnel, technical capacity, working hours etc., however, in general, all share the interest, understand the importance of applying the concept of the 3R's and deem more support with greater investment and development in this area necessary. According to the OPLs, bureaucratic and regulatory procedures need to be further discussed with regard to the applicability of the 3R's concept, in order to facilitate the validation, the use of alternative methods and a higher acting of the Brazilian Pharmacopoeia In updating already validated and accepted methods. In general, it is necessary to leave an auspicious scenario to the development, production and quality control actions, of the immunobiological products of OPLs.