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INCQS participates in a study to replace the use of animals to produce anti-rabies vaccines


Penélope Toledo (INCQS/Fiocruz)


The team of the Viral Vaccines Laboratory of the National Institute for Quality Control in Health (INCQS/Fiocruz), which works with immunobiological drugs against rabies (LVV-Raiva), is participating in the second phase of an international study to replace potency assays in anti-rabies vaccines, traditionally made using mice for over 50 years. 

Under code BSP148 and funded by the European Directorate for the Quality of Medicines and Healthcare (EDQM), an institution of the Council of Europe in charge of the issuing of the European Pharmacopoeia, the research aims to validate the immuno-enzymatic method (ELISA) that consists in the use of antibodies marked with an enzyme.

“The study is based on the creation of a protocol and of a study design, testing 10 samples using a pair of monoclonal antibodies that can bind to conformational epitopes, in well-defined antigenic positions, inducers of protection”, explains Wlamir Moura, one of the participants.

Thirty-four laboratories of different countries participated in this phase, to evaluate the assay’s transfer capacity. INCQS/Fiocruz was one of these laboratories. The Institute’s participation was made possible thanks to a project in a partnership with the National Agency of Sanitary Surveillance (Anvisa), which is currently ongoing and which aims to implement alternative methods in the country. The series of assays is complete and the results were submitted to the EDQM in September.

The LVV-Raiva/INCQS/Fiocruz has been part of this initiative since its first meeting, in Ames, USA, in 2011, and has been part of the workgroup since then. In the previous phase of the study, the Institute provided one of the anti-rabies vaccines tested.

After the conclusion of the second phase, the results will be published in an indexed journal and the international workgroup will elaborate a new project to carry out phase 3 of the study. “The Viral Vaccines Laboratory, with the support of the Brazilian Center for Validation of Alternative Methods (BraCVAM), will seek to obtain the resources necessary to make sure the ELISA is incorporated into the routine of assays and, in the future, can replace animal testing”, declared Moura.

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