mRNA vaccine formulations are generally considered to pose a lower genotoxic risk than conventional small-molecule pharmaceuticals; however, long-term data regarding their potential genotoxicity remain limited. Furthermore, to date, no standardized genotoxicity testing guidelines specifically tailored to the unique characteristics of mRNA vaccines have been formally established. In this study, we conducted a comprehensive geno...

Cardiotoxicity remains the leading driver of drug attrition; however, its prediction remains suboptimal when conventional hERG assays and animal models are used. Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) offer a human-relevant alternative that aligns with the CiPA initiative and ICH E14/S7B guidelines. This study validated an integrated platform that combines high-purity hiPSC-CMs with Artificial I...

The increasing use of SARS-CoV-2 mRNA vaccines has raised concerns about their potential toxicological effects, necessitating further investigation to ensure their safety. To address this issue, we aimed to evaluate the toxicological effects of SARS-CoV-2 mRNA vaccine candidates formulated with four different types of lipid nanoparticles in ICR mice, focusing on repeated doses and administration routes. We conducted an extensi...