Article

Regulatory Assessment Gaps and Genotoxicity Considerations in mRNA-LNP Technologies

2025-10-20

Abstract excerpt

Current FDA and ICH genotoxicity requirements allow pharmaceutical developers to meet safety obligations using legacy assays designed for small, cell permeable chemicals, resulting in the use of bacterial reverse-mutation tests (Ames) and in vitro micronucleus assays in human peripheral blood mononuclear cells (PBMCs) to evaluate the presumed non genotoxicity of lipid nanoparticle (LNP) based platforms, including...

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Literature Corpus work: a752139a-554c-520a-8108-bb6900e06f5a
DOI: 10.20944/preprints202510.1433.v1

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