Application of alternative methods to the use of animals in the development and quality control of immunobiological products in Brazil: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02126 | Published on: 19/04/2023

• Autor(a) principal: Küster Gon, Rafaela
• Data de Publicação: 2023
• Outros Autores: Mauro Granjeiro, José, Fernandes Delgado, Isabella
• 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/2126
• topic: Métodos Alternativos; 3Rs; Laboratórios Públicos Oficiais; Controle da Qualidade; Produtos Imunobiológicos; Alternative Methods; 3Rs; Official Public Laboratories; Quality Control; Immunobiological Products

Introduction: For decades, the need, number and predictive potential of the use of animals for research purposes, production and quality control of various products have been  questioned. Objective: To map the in vivo tests used in official public laboratories (LPO), verifying the application or not of alternative methods. Method: LPOs were identified and invited to answer a screening questionnaire to map the alternative methods used by them, followed by an interview to assess interest in developing a new alternative method, application of the 3Rs principle, and manufacturers’ perception of regarding the trend of substitution by alternative methods. Results: Brazilian LPOs reported difficulties in implementing in vitro alternatives, including the need to adapt infrastructure, insufficient personnel and lack of training of technical staff. Some respondents claim the need to systematize the bureaucratic and regulatory procedures applicable to the concept of the 3Rs in the field of immunobiologicals. All respondents showed interest in implementing in vitro alternatives, pointing out advantages such as: reduction of time and cost of analyses, greater accuracy of results, minimization of difficulties inherent to in vivo tests and animal handling. Conclusions: Promoting a scenario - from a political, technical and regulatory point of view - more conducive to the validation and implementation of alternative methods in Brazil will contribute to the reduction of cost and time in the release of lots of immunobiological products. There is room for reducing the use of animals in some in vivo tests used in LPO, however, there is a need for investment in infrastructure and qualified personnel in alternative testing.