VisMederi possesses laboratories and research facilities necessary to completely cover all procedures for the development of clinical trials for vaccines
Ever since its foundation, VisMederi has focused its attention for the most part on the development of serological tests requested for the registration of both seasonal and pandemic influenza vaccines on behalf of international regulatory bodies such as the EMA (European Medicines Agency), FDA (Food and Drug Administration) and the PMDA (Pharmaceuticals and Medical Devices Agency). The assays performed at VisMederi continually undergo validation processes in accordance with international guidelines, so as to demonstrate the trustworthiness and robustness of its tests.
Traditional assays for the evaluation of virus vaccine immunogenicity, for example Hemoagglutination Inhibition (HAI), Single Radial Hemolysis (SRH) and Virus Neutralization (VN), characterize VisMederi daily research. In this context, the experience accumulated throughout the years allow it to guarantee high quality in test results together with very rapid completion times.
In order to respond effectively to the needs of current and potential partners, VisMederi works continually for the optimization and validation of serological assays, with particular focus towards innovative platforms. In this area of research, important results have been reached with the use of innovative pseudo-viral particles for Microneutralization tests and with the development of immunoenzymatic doses used for the evaluation of the response toward the neuramidase in influenza vaccines (ELLA test).
Finalizing this area of research and in addition to the test panels available for humoral immune responses, cell-mediated immune response study protocols have been implemented through EliSpot and FACS platforms. VisMederi conducts laboratory research for the evaluation of immune responses to vaccines against bacterial strains as well, through bactericide tests (SBA-Assay) and opsonization (OPA-Assay).
Recently, VisMederi has developed and validated numerous assays that can be used for vaccine efficacy studies. In addition to the isolation of microorganisms in cell cultures and the molecular identification of viral and bacterial isolates from clinical samples, quantization of microorganisms through real-time PCR are of particular importance in this area of research