Retrospective Evaluation Of Unspecific Toxicity Tests Performed At The National Institute For Quality Control In Health On Biological Products

Introduction:The in vivo toxicity test known as Unspecific Toxicity Test (ITT) is recommended to assess the safety of biological products and biotechnology derivatives. The principle of this test is the administration of the product in guinea pigs and mice, followed by an observation period. INCQS is the Brazilian National Control Laboratory (NCL) that works controlling biological products, especially vaccines and hyperimmune sera for the Immunization National Program (INP) before going to market. Chemical, microbiological and toxicological tests are performed, including ITT. Objective: To analyze the ITT performed at INCQS and to verify the monographs of the Brazilian Pharmacopeia where the test is still recommended. Method: A survey was carried out with the Harpya data system, which is used to record all samples and analyses. Results: From 1999 to 2012, 3,453 ITT were performed on biological products, resulting in 100% negative results. Based on these results and following a worldwide trend, since 2002 INCQS has been gradually reducing the amount of vaccines and hyperimmune sera submitted to the unspecific toxicity test. Currently, the risk of contamination of pharmaceutical products with non-specific substances is significantly low, as industries are regulated to comply with Good Manufacturing Practices (GMP). Although ITT still remains in the General Tests of the Brazilian Pharmacopoeia, it is not required in specific monographs of hyperimmune sera and vaccines for human use. Conclusions: These results show that ITT appears to be not enough efficient for detecting nonspecific toxicity due to biological products manufacture and Brazil may follow the worldwide trend to stop performing it.