ELISA AND MODIFIED TOBI FOR QUALITY CONTROL OF VIRAL VACCINE PROCESSES: AN INTEGRATIVE LITERATURE REVIEW

Abstract

The development of vaccines, which are of great importance to society, combines in vitro methods and the use of laboratory animals (in vivo testing) in distinct and complementary stages of the research and validation process. Although in vitro methods are crucial in the initial phase, the use of animals remains a mandatory step to ensure safety and efficacy before human trials. However, the search for alternatives to animal use in immunogenicity, safety, and vaccine potency assays has been ongoing among researchers in the field. This study aimed to analyze and synthesize the available scientific knowledge regarding the use of the ELISA test (Enzyme-Linked Immunosorbent Assay) and the Toxin Binding Inhibition Test (ToBI), adapted for application in quality control throughout viral vaccine batch release processes. This study consists of an integrative literature review, a method that enables the synthesis of multiple studies and approaches for a comprehensive understanding of the phenomenon. The literature search was conducted in the SciELO, PubMed, and Google Scholar databases. It is expected that the synthesis of knowledge presented will contribute to new research and practices regarding alternative methods to animal use in safety evaluation assays and in the production of immune responses for viral vaccines.